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Volumn , Issue , 2013, Pages 1-411

Biosimilars: Design and analysis of follow-on biologics

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EID: 85054711441     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b15303     Document Type: Book
Times cited : (25)

References (262)
  • 2
    • 0024988106 scopus 로고
    • Consideration of individual bioequivalence
    • Anderson, S. and Hauck, W.W. (1990). Consideration of individual bioequivalence. J. Pharmacokinet. Biopharm., 18, 259–273.
    • (1990) J. Pharmacokinet. Biopharm. , vol.18 , pp. 259-273
    • Anderson, S.1    Hauck, W.W.2
  • 3
    • 0013501279 scopus 로고
    • Bound on expectations of linear systematic statistics based on dependent samples
    • Arnold, B. and Groeneveld, R. (1979). Bound on expectations of linear systematic statistics based on dependent samples. Ann. Statist., 7, 220–223.
    • (1979) Ann. Statist. , vol.7 , pp. 220-223
    • Arnold, B.1    Groeneveld, R.2
  • 4
    • 84919436881 scopus 로고
    • Multiparametric hypothesis testing and acceptance sampling
    • Berger, R.L. (1982). Multiparametric hypothesis testing and acceptance sampling. Technometrics, 24, 295–300.
    • (1982) Technometrics , vol.24 , pp. 295-300
    • Berger, R.L.1
  • 5
    • 0029567034 scopus 로고
    • An approach for widening the bioequivalence limits in the case of highly variable drugs
    • Boddy, A.W., Snikeris, F.C., Kringle, R.O., Wei, G.C.G., Opperman, J.A., and Midha, K.K. (1995). An approach for widening the bioequivalence limits in the case of highly variable drugs. Pharm. Res., 12, 1865–1868.
    • (1995) Pharm. Res. , vol.12 , pp. 1865-1868
    • Boddy, A.W.1    Snikeris, F.C.2    Kringle, R.O.3    Wei, G.C.G.4    Opperman, J.A.5    Midha, K.K.6
  • 7
    • 80051997026 scopus 로고
    • Robust tests for the equality of variances
    • Brown, M.B. and Forsythe, A.B. (1974). Robust tests for the equality of variances. J. Am. Statist. Assoc., 69, 364–367.
    • (1974) J. Am. Statist. Assoc. , vol.69 , pp. 364-367
    • Brown, M.B.1    Forsythe, A.B.2
  • 8
    • 0037473207 scopus 로고    scopus 로고
    • Assessing individual bioequivalence using structural equation model
    • Carrasco, J.L. and Jover, L. (2003). Assessing individual bioequivalence using structural equation model. Stat. Med, 22, 901–912.
    • (2003) Stat. Med , vol.22 , pp. 901-912
    • Carrasco, J.L.1    Jover, L.2
  • 9
    • 0026524109 scopus 로고
    • Statistical approaches to stability protocol design
    • Carstenson, J.T., Franchini, M., and Ertel, K. (1992). Statistical approaches to stability protocol design. J. Pharm. Sci., 81, 303–308.
    • (1992) J. Pharm. Sci. , vol.81 , pp. 303-308
    • Carstenson, J.T.1    Franchini, M.2    Ertel, K.3
  • 13
    • 85054762396 scopus 로고    scopus 로고
    • Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Off. J. Eur. Union L 159/46
    • CD. (2003). Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Off. J. Eur. Union L 159/46.
    • (2003)
  • 14
    • 84882524588 scopus 로고    scopus 로고
    • CMC issues and regulatory requirements for biosimilars
    • Chen, B.L. (2009). CMC issues and regulatory requirements for biosimilars. Trends Bio/Pharm. Ind., 5, 19–26.
    • (2009) Trends Bio/Pharm. Ind. , vol.5 , pp. 19-26
    • Chen, B.L.1
  • 15
    • 85054717661 scopus 로고    scopus 로고
    • FDA’s views on bracketing and matrixing. EFPIA Symposium: Advanced Topics in Pharmaceutical Stability Testing—Building in the ICH Guideline, Brussels, Belgium, October 1996
    • Chen, C. (1996). FDA’s views on bracketing and matrixing. EFPIA Symposium: Advanced Topics in Pharmaceutical Stability Testing—Building in the ICH Guideline, Brussels, Belgium, October 1996.
    • (1996)
    • Chen, C.1
  • 16
    • 0031397277 scopus 로고    scopus 로고
    • A note on sample size determination for bioequivalence studies with higher-order crossover designs
    • Chen, K.W., Chow, S.C., and Li, G. (1997). A note on sample size determination for bioequivalence studies with higher-order crossover designs. J. Pharm. Biopharm., 25, 753–765.
    • (1997) J. Pharm. Biopharm. , vol.25 , pp. 753-765
    • Chen, K.W.1    Chow, S.C.2    Li, G.3
  • 17
    • 0030503894 scopus 로고    scopus 로고
    • A confidence region approach for assessing equivalence in variability of bioavailability
    • Chen, K.W., Li, G., Sun, Y., and Chow, S.C. (1996). A confidence region approach for assessing equivalence in variability of bioavailability. Biom. J., 4, 475–487.
    • (1996) Biom. J. , Issue.4 , pp. 475-487
    • Chen, K.W.1    Li, G.2    Sun, Y.3    Chow, S.C.4
  • 19
    • 0030949859 scopus 로고    scopus 로고
    • Individual bioequivalence—A regulatory update
    • Chen, M.L. (1997). Individual bioequivalence—A regulatory update. J. Biopharm. Stat., 7, 5–11.
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 5-11
    • Chen, M.L.1
  • 21
    • 0029744834 scopus 로고    scopus 로고
    • Design and analysis of intra-subject variability in cross-over experiments
    • Chinchilli, V.M. and Esinhart, J.D. (1996). Design and analysis of intra-subject variability in cross-over experiments. Stat. Med., 15, 1619–1634.
    • (1996) Stat. Med. , vol.15 , pp. 1619-1634
    • Chinchilli, V.M.1    Esinhart, J.D.2
  • 22
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • Chirino, A.J. and Mire-Sluis, A. (2004). Characterizing biological products and assessing comparability following manufacturing changes. Nat. Biotechnol., 22, 1383–1391.
    • (2004) Nat. Biotechnol. , vol.22 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 24
    • 38249031695 scopus 로고
    • A new procedure for the estimation of variance components
    • Chow, S.C. (1988). A new procedure for the estimation of variance components. Stat. Prob. Lett., 6, 349–355.
    • (1988) Stat. Prob. Lett. , vol.6 , pp. 349-355
    • Chow, S.C.1
  • 26
    • 0033038778 scopus 로고    scopus 로고
    • Individual bioequivalence-A review of the FDA draft guidance
    • Chow, S.C. (1999). Individual bioequivalence-A review of the FDA draft guidance. Drug Inf. J., 33, 435–444.
    • (1999) Drug Inf. J. , vol.33 , pp. 435-444
    • Chow, S.C.1
  • 28
    • 85054711115 scopus 로고    scopus 로고
    • On Scientific factors of biosimilarity and interchangeability. Presented at FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products. Silver Spring, MD
    • Chow, S.C. (2010). On Scientific factors of biosimilarity and interchangeability. Presented at FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products. Silver Spring, MD, November 2–3, 2010.
    • (2010) November , vol.2010 , pp. 2-3
    • Chow, S.C.1
  • 29
    • 84872387851 scopus 로고    scopus 로고
    • Quantitative evaluation of bioequivalence/biosimilarity
    • Chow, S.C. (2011). Quantitative evaluation of bioequivalence/biosimilarity. J. Bioequiv. Bioavailab., Suppl. 1-002, 1–8, http://dx.doi.org/10.4172/jbbs1-002.
    • (2011) J. Bioequiv. Bioavailab. , pp. 1-8
    • Chow, S.C.1
  • 30
    • 84872419787 scopus 로고    scopus 로고
    • Assessing biosimilarity and drug interchangeability of biosimilar products
    • Chow, S.C. (2013). Assessing biosimilarity and drug interchangeability of biosimilar products. Stat. Med., 32, 361–363.
    • (2013) Stat. Med. , vol.32 , pp. 361-363
    • Chow, S.C.1
  • 31
    • 84872416874 scopus 로고    scopus 로고
    • Comments on FDA draft guidances on biosimilar products
    • Chow, S.C., Endrenyi, L., and Lachenbruch, P.A. (2013a). Comments on FDA draft guidances on biosimilar products. Stat. Med., 32, 364–369.
    • (2013) Stat. Med. , vol.32 , pp. 364-369
    • Chow, S.C.1    Endrenyi, L.2    Lachenbruch, P.A.3
  • 32
    • 79960341709 scopus 로고    scopus 로고
    • Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics
    • Chow, S.C., Endrenyi, L., Lachenbruch, P.A., Yang, L.Y., and Chi, E. (2011). Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars, 1, 13–26.
    • (2011) Biosimilars , vol.1 , pp. 13-26
    • Chow, S.C.1    Endrenyi, L.2    Lachenbruch, P.A.3    Yang, L.Y.4    Chi, E.5
  • 33
    • 75649124109 scopus 로고    scopus 로고
    • A comparison of moment-based and probability-based criteria for assessment of follow-on biologics
    • Chow, S.C., Hsieh, T.C., Chi, E., and Yang, J. (2010a). A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. J. Biopharm. Stat., 20, 31–45.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 31-45
    • Chow, S.C.1    Hsieh, T.C.2    Chi, E.3    Yang, J.4
  • 34
    • 75649086457 scopus 로고    scopus 로고
    • Statistical methods for assessment of biosimilarity using biomarker data
    • Chow, S.C., Lu, Q., Tse, S.K., and Chi, E. (2010b). Statistical methods for assessment of biosimilarity using biomarker data. J. Biopharm. Stat., 20, 90–105.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 90-105
    • Chow, S.C.1    Lu, Q.2    Tse, S.K.3    Chi, E.4
  • 35
    • 0034732697 scopus 로고    scopus 로고
    • Statistical analysis for placebo-challenging design in clinical trials
    • Chow, S.C., Shao, J., and Ho, H.C. (2000). Statistical analysis for placebo-challenging design in clinical trials, Stat. Med., 19, 1029–1037.
    • (2000) Stat. Med. , vol.19 , pp. 1029-1037
    • Chow, S.C.1    Shao, J.2    Ho, H.C.3
  • 36
    • 9244263007 scopus 로고    scopus 로고
    • Assessing bioequivalence using genomic data
    • Chow, S.C., Shao, J., and Li, L. (2004). Assessing bioequivalence using genomic data. J. Biopharm. Stat., 14, 869–880.
    • (2004) J. Biopharm. Stat. , vol.14 , pp. 869-880
    • Chow, S.C.1    Shao, J.2    Li, L.3
  • 37
    • 0037088339 scopus 로고    scopus 로고
    • Individual bioequivalence testing under 2 × 3 crossover designs
    • Chow, S.C., Shao, J., and Wang, H. (2002). Individual bioequivalence testing under 2 × 3 crossover designs. Stat. Med., 21, 629–648.
    • (2002) Stat. Med. , vol.21 , pp. 629-648
    • Chow, S.C.1    Shao, J.2    Wang, H.3
  • 39
    • 84872382872 scopus 로고    scopus 로고
    • Scientific considerations for assessing biosimilar products
    • Chow, S.C., Wang, J., Endrenyi, L., and Lachenbruch, P.A. (2013b). Scientific considerations for assessing biosimilar products. Stat. Med., 32, 370–381.
    • (2013) Stat. Med. , vol.32 , pp. 370-381
    • Chow, S.C.1    Wang, J.2    Endrenyi, L.3    Lachenbruch, P.A.4
  • 40
    • 84872383751 scopus 로고    scopus 로고
    • Statistical methods for assessing interchangeability of biosimilars
    • Chow, S.C., Yang, L.Y., Starr, A, and Chiu, S.T. (2013c). Statistical methods for assessing interchangeability of biosimilars. Stat. Med., 32, 442–448.
    • (2013) Stat. Med. , vol.32 , pp. 442-448
    • Chow, S.C.1    Yang, L.Y.2    Starr, A.3    Chiu, S.T.4
  • 43
    • 0030998774 scopus 로고    scopus 로고
    • Statistical comparison between dissolution profiles of drug products
    • Chow, S.C. and Ki, F. (1997). Statistical comparison between dissolution profiles of drug products. J. Biopharm. Stat., 7, 241–258.
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 241-258
    • Chow, S.C.1    Ki, F.2
  • 45
    • 0030907413 scopus 로고    scopus 로고
    • Meta-analysis for bioequivalence review
    • Chow, S.C. and Liu, J.P. (1997). Meta-analysis for bioequivalence review. J. Biopharm. Stat., 7, 97–111.
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 97-111
    • Chow, S.C.1    Liu, J.P.2
  • 47
    • 75649146954 scopus 로고    scopus 로고
    • Statistical assessment of biosimilar products
    • Chow, S.C. and Liu, J.P. (2010). Statistical assessment of biosimilar products. J. Biopharm. Stat., 20, 10–30.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 10-30
    • Chow, S.C.1    Liu, J.P.2
  • 48
    • 0025994942 scopus 로고
    • Estimating drug shelf-life with random batches
    • Chow, S.C. and Shao, J. (1991). Estimating drug shelf-life with random batches. Biometrics, 47, 1071–1079.
    • (1991) Biometrics , vol.47 , pp. 1071-1079
    • Chow, S.C.1    Shao, J.2
  • 49
    • 0030965772 scopus 로고    scopus 로고
    • Statistical methods for two-sequence dual crossover designs with incomplete data
    • Chow, S.C. and Shao, J. (1997). Statistical methods for two-sequence dual crossover designs with incomplete data. Stat. Med., 16, 1031–1039.
    • (1997) Stat. Med. , vol.16 , pp. 1031-1039
    • Chow, S.C.1    Shao, J.2
  • 50
    • 0032867106 scopus 로고    scopus 로고
    • Bioequivalence review for drug interchangeability
    • Chow, S.C. and Shao, J. (1999). Bioequivalence review for drug interchangeability. J. Biopharm. Stat., 9, 485–497.
    • (1999) J. Biopharm. Stat. , vol.9 , pp. 485-497
    • Chow, S.C.1    Shao, J.2
  • 52
    • 0036776070 scopus 로고    scopus 로고
    • A note on statistical methods for assessing therapeutic equivalence
    • Chow, S.C. and Shao, J. (2002b). A note on statistical methods for assessing therapeutic equivalence. Controll. Clin. Trials, 23, 515–520.
    • (2002) Controll. Clin. Trials , vol.23 , pp. 515-520
    • Chow, S.C.1    Shao, J.2
  • 53
    • 33645468869 scopus 로고    scopus 로고
    • On non-inferiority margin and statistical test in active control trials
    • Chow, S.C. and Shao, J. (2006). On non-inferiority margin and statistical test in active control trials. Stat. Med., 25, 1101–1113.
    • (2006) Stat. Med. , vol.25 , pp. 1101-1113
    • Chow, S.C.1    Shao, J.2
  • 54
    • 84981986855 scopus 로고
    • A related problem in bioavailability/bioequivalence studies—Estimation of intrasubject variability with a common CV
    • Chow, S.C. and Tse, S.K. (1990). A related problem in bioavailability/bioequivalence studies—Estimation of intrasubject variability with a common CV. Biomet. J., 32, 597–607.
    • (1990) Biomet. J. , vol.32 , pp. 597-607
    • Chow, S.C.1    Tse, S.K.2
  • 55
    • 0025816887 scopus 로고
    • On the estimation of total variability in assay validation
    • Chow, S.C. and Tse, S.K. (1991). On the estimation of total variability in assay validation. Stat. Med., 10, 1543–1553.
    • (1991) Stat. Med. , vol.10 , pp. 1543-1553
    • Chow, S.C.1    Tse, S.K.2
  • 56
    • 0002528731 scopus 로고
    • The estimation of reliability from stress–strength relationships
    • Church, J.D. and Harris, B. (1970). The estimation of reliability from stress–strength relationships. Technometrics, 12, 49–54.
    • (1970) Technometrics , vol.12 , pp. 49-54
    • Church, J.D.1    Harris, B.2
  • 57
    • 0001654912 scopus 로고
    • Rank tests for one sample, two samples, and k samples without the assumption of a continuous distribution function
    • Conover, W.J. (1973). Rank tests for one sample, two samples, and k samples without the assumption of a continuous distribution function. Ann. Stat., 1, 1105–1125.
    • (1973) Ann. Stat. , vol.1 , pp. 1105-1125
    • Conover, W.J.1
  • 59
    • 0039955934 scopus 로고
    • The evaluation of bioequivalence using nonparametric procedures
    • Cornell, R.G. (1990). The evaluation of bioequivalence using nonparametric procedures. Commun. Stat.: Theory Methods, 19, 4153–4169.
    • (1990) Commun. Stat.: Theory Methods , vol.19 , pp. 4153-4169
    • Cornell, R.G.1
  • 66
    • 51249120275 scopus 로고    scopus 로고
    • Highly variable drugs: Observations from bioequivalence data submitted to the FDA for new generic drug applications
    • Davit, B.M., Conner, D.P., Fabian-Fritsch, B. et al. (2008). Highly variable drugs: Observations from bioequivalence data submitted to the FDA for new generic drug applications. AAPS J, 10, 148–156.
    • (2008) AAPS J , vol.10 , pp. 148-156
    • Davit, B.M.1    Conner, D.P.2    Fabian-Fritsch, B.3
  • 68
    • 0030950712 scopus 로고    scopus 로고
    • Some optimal matrix designs in stability studies
    • DeWoody, K. and Raghavarao, D. (1997). Some optimal matrix designs in stability studies. J. Biopharm. Stat., 7, 205–213.
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 205-213
    • Dewoody, K.1    Raghavarao, D.2
  • 69
    • 0037473213 scopus 로고    scopus 로고
    • Kullback-Leibler divergence for evaluating bioequivalence
    • Dragalin, V., Fedorov, V., Patterson, S. et al. (2003). Kullback-Leibler divergence for evaluating bioequivalence. Stat. Med., 22, 913–930.
    • (2003) Stat. Med. , vol.22 , pp. 913-930
    • Dragalin, V.1    Fedorov, V.2    Patterson, S.3
  • 70
    • 26444433586 scopus 로고
    • Bayesian statistical inference for psychological research
    • Edwards, W., Lindman, H., and Savage, L.J. (1963). Bayesian statistical inference for psychological research. Psycol. Rev., 70, 193.
    • (1963) Psycol. Rev. , vol.70 , pp. 193
    • Edwards, W.1    Lindman, H.2    Savage, L.J.3
  • 71
    • 0003478656 scopus 로고    scopus 로고
    • The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/EWP/QWP/1401/98, London, U.K
    • EMA. (2001). Note for guidance on the investigation of bioavailability and bioequivalence. The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/EWP/QWP/1401/98, London, U.K.
    • (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence.
  • 74
    • 33644952525 scopus 로고    scopus 로고
    • The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/ CHMP/437/04, London, U.K
    • EMA. (2006a). Guideline on similar biological medicinal products. The European Medicines Agency Evaluation of Medicines for Human Use. EMEA/ CHMP/437/04, London, U.K.
    • (2006) Guideline on Similar Biological Medicinal Products.
  • 92
    • 84872423673 scopus 로고    scopus 로고
    • On the interchangeability of biologic drug products
    • Endrenyi, L., Chang, C., Chow, S.C., and Tothfalusi, L. (2013). On the interchangeability of biologic drug products. Stat. Med., 32, 434–441.
    • (2013) Stat. Med. , vol.32 , pp. 434-441
    • Endrenyi, L.1    Chang, C.2    Chow, S.C.3    Tothfalusi, L.4
  • 94
    • 70349316406 scopus 로고    scopus 로고
    • Regulatory and study conditions for the determination of bioequivalence of highly variable drugs
    • Endrenyi, L. and Tothfalusi, L. (2009). Regulatory and study conditions for the determination of bioequivalence of highly variable drugs. J. Pharm. Pharm. Sci., 12, 138–149.
    • (2009) J. Pharm. Pharm. Sci. , vol.12 , pp. 138-149
    • Endrenyi, L.1    Tothfalusi, L.2
  • 95
    • 0001432540 scopus 로고
    • Estimation of the probability that Y < X
    • Enis, P. and Geisser, S. (1971). Estimation of the probability that Y < X. J. Am. Stat. Assoc., 66, 162–168.
    • (1971) J. Am. Stat. Assoc. , vol.66 , pp. 162-168
    • Enis, P.1    Geisser, S.2
  • 97
    • 0028790317 scopus 로고
    • Regulatory, design, and analysis aspects of complex stability studies
    • Fairweather, W.R., Lin, T.D., and Kelly, R. (1995). Regulatory, design, and analysis aspects of complex stability studies. J. Pharm. Sci., 84, 1322–1326.
    • (1995) J. Pharm. Sci. , vol.84 , pp. 1322-1326
    • Fairweather, W.R.1    Lin, T.D.2    Kelly, R.3
  • 98
    • 0003625861 scopus 로고
    • Center for Drugs and Biologics, Office of Drug Research and Review, Food and Drug Administration, Rockville, MD
    • FDA. (1987). Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics. Center for Drugs and Biologics, Office of Drug Research and Review, Food and Drug Administration, Rockville, MD.
    • (1987) Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics
  • 100
    • 0004324584 scopus 로고
    • Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD
    • FDA. (1992). Guidance on Statistical Procedures for Bioequivalence Using a Standard Two-treatment Crossover Design. Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD.
    • (1992) Guidance on Statistical Procedures for Bioequivalence Using a Standard Two-Treatment Crossover Design
  • 101
    • 85054735902 scopus 로고    scopus 로고
    • FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products, the U.S. Food and Drug Administration, Rockville, MD
    • FDA. (1996). FDA guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products, the U.S. Food and Drug Administration, Rockville, MD.
    • (1996)
  • 105
    • 0003922013 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD
    • FDA. (2001). Guidance on statistical approaches to establishing bioequivalence. Center for Drug Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD.
    • (2001) Guidance on Statistical Approaches to Establishing Bioequivalence
  • 110
    • 77954882772 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Siler Spring, MD
    • FDA. (2010). Guidance for industry—Non-inferiority clinical trials. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Siler Spring, MD.
    • (2010) Guidance for industry—Non-inferiority Clinical Trials
  • 114
    • 0000991825 scopus 로고
    • Some problems in interval estimation
    • Fieller, E. (1954). Some problems in interval estimation. J. R. Stat. Soc., Series B, 16, 175–185.
    • (1954) J. R. Stat. Soc., Series B , vol.16 , pp. 175-185
    • Fieller, E.1
  • 116
    • 0034038181 scopus 로고    scopus 로고
    • Design and interpretation of equivalence trials
    • Fleming, T.R. (2000). Design and interpretation of equivalence trials. Am. Heart J., 139, S172–S176.
    • (2000) Am. Heart J. , vol.139 , pp. S172-S176
    • Fleming, T.R.1
  • 117
    • 75649122517 scopus 로고    scopus 로고
    • Biosimilar medicines—New challenges for new class of medicine
    • Fox, A. (2010). Biosimilar medicines—New challenges for new class of medicine. J. Biopharm. Stat., 20, 1–9.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 1-9
    • Fox, A.1
  • 118
    • 85006569338 scopus 로고    scopus 로고
    • Generics grab 80% share of US market and fill 78% of prescriptions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International, Accessed on March 23, 2012
    • GaBI Online. (2012a). Generics and biosimilars initiative. Generics grab 80% share of US market and fill 78% of prescriptions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International. www.gabionline.net/Reports/ Generics-grab-80-share-of-US-marketand-fill-78-of-prescriptions. Accessed on March 23, 2012.
    • (2012) Generics and Biosimilars Initiative
  • 119
    • 85006569338 scopus 로고    scopus 로고
    • Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International, Accessed on March 23, 2012
    • GaBI Online. (2012b). Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International. www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed on March 23, 2012.
    • (2012) Generics and Biosimilars Initiative
  • 120
    • 0026600656 scopus 로고
    • A common on replication, p-values and evidence
    • Goodman, S.N. (1992). A common on replication, p-values and evidence. Stat. Med., 11, 875–879.
    • (1992) Stat. Med. , vol.11 , pp. 875-879
    • Goodman, S.N.1
  • 121
    • 0028863992 scopus 로고
    • Group sequential extensions of Standard bioequivalence testing procedure
    • Gould, A.L. (1995). Group sequential extensions of Standard bioequivalence testing procedure. J. Pharmacokinet. Biopharm., 23, 57–85.
    • (1995) J. Pharmacokinet. Biopharm. , vol.23 , pp. 57-85
    • Gould, A.L.1
  • 122
    • 75649130156 scopus 로고    scopus 로고
    • Generic Pharmaceutical Association, December 8, 2004. Docket No. 2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products, U.S. Food and Drug Administration, Rockville, MD
    • GPhA. (2004). Biopharmaceuticals (follow-on protein products): Scientific considerations for an abbreviated approval pathway. Generic Pharmaceutical Association, December 8, 2004. Docket No. 2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products, U.S. Food and Drug Administration, Rockville, MD.
    • (2004) Biopharmaceuticals (Follow-On Protein Products): Scientific Considerations for an Abbreviated Approval Pathway
  • 123
    • 0000521797 scopus 로고
    • Confidence intervals on nonnegative linear combinations of variances
    • Graybill, F. and Wang, C.M. (1980). Confidence intervals on nonnegative linear combinations of variances. J. Am. Stat. Assoc., 75, 869–873.
    • (1980) J. Am. Stat. Assoc. , vol.75 , pp. 869-873
    • Graybill, F.1    Wang, C.M.2
  • 124
    • 0002663322 scopus 로고
    • The maxima of the mean largest value and of the range
    • Gumbel, E.J. (1954). The maxima of the mean largest value and of the range. Ann. Math. Statist., 25, 76–84.
    • (1954) Ann. Math. Statist. , vol.25 , pp. 76-84
    • Gumbel, E.J.1
  • 125
    • 38049184592 scopus 로고    scopus 로고
    • Bioequivalence approaches for highly variable drugs and drug products
    • Haidar, S.H., Davit, B.M., Chen, M.L. et al. (2008). Bioequivalence approaches for highly variable drugs and drug products. Pharm. Res., 25, 237–241.
    • (2008) Pharm. Res. , vol.25 , pp. 237-241
    • Haidar, S.H.1    Davit, B.M.2    Chen, M.L.3
  • 126
    • 57149091543 scopus 로고    scopus 로고
    • Evaluation of a scaling approach for the bioequivalence of highly variable drugs
    • Haidar, S.H., Makhlouf, F., Schuirmann, D.J., Hyslop, T., Davit, B., Conner, D., and Yu, L.X. (2008). Evaluation of a scaling approach for the bioequivalence of highly variable drugs. AAPS J., 10, 450–454.
    • (2008) AAPS J , vol.10 , pp. 450-454
    • Haidar, S.H.1    Makhlouf, F.2    Schuirmann, D.J.3    Hyslop, T.4    Davit, B.5    Conner, D.6    Yu, L.X.7
  • 127
    • 0002515764 scopus 로고
    • Universal bounds for mean range and extreme observation
    • Hartley, H.O. and David, H.A. (1954). Universal bounds for mean range and extreme observation. Ann. Math. Statist., 25, 85–99.
    • (1954) Ann. Math. Statist. , vol.25 , pp. 85-99
    • Hartley, H.O.1    David, H.A.2
  • 128
    • 0027097542 scopus 로고
    • Sample size determination for bioequivalence assessment using a multiplicative model
    • Hauschke, D., Steinijans, V.W., Diletti, E., and Burke, W. (1992). Sample size determination for bioequivalence assessment using a multiplicative model. J. Pharmacokinet. Biopharm., 20, 557–581.
    • (1992) J. Pharmacokinet. Biopharm. , vol.20 , pp. 557-581
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3    Burke, W.4
  • 129
    • 0025332058 scopus 로고
    • A distribution-free procedure for the statistical analyses of bioequivalence studies
    • Hauschke, D., Steinijians, V.W., and Diletti, E. (1990). A distribution-free procedure for the statistical analyses of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol., 28, 72–78.
    • (1990) Int. J. Clin. Pharmacol. Ther. Toxicol. , vol.28 , pp. 72-78
    • Hauschke, D.1    Steinijians, V.W.2    Diletti, E.3
  • 134
    • 0026462857 scopus 로고
    • New designs for stability testing programs: Matrix or factorial designs. Authorities’ viewpoint on the predictive value of such studies
    • Helboe, P. (1992). New designs for stability testing programs: Matrix or factorial designs. Authorities’ viewpoint on the predictive value of such studies. Drug Inform. J., 26, 629–634.
    • (1992) Drug Inform. J. , vol.26 , pp. 629-634
    • Helboe, P.1
  • 135
    • 0000722255 scopus 로고
    • Approximate confidence limits on the mean of X + Y where X and Y are two tabled independent random variables
    • Howe, W.G. (1974). Approximate confidence limits on the mean of X + Y where X and Y are two tabled independent random variables. J. Am. Stat. Assoc., 69, 789–794.
    • (1974) J. Am. Stat. Assoc. , vol.69 , pp. 789-794
    • Howe, W.G.1
  • 136
    • 75649092932 scopus 로고    scopus 로고
    • Statistical test for evaluation of biosimilarity of follow-on biologics
    • Hsieh, T.C., Chow, S.C., Liu, J.P., Hsiao, C.F., and Chi, E. (2010). Statistical test for evaluation of biosimilarity of follow-on biologics. J. Biopharm. Stat., 20, 20, 75–89.
    • (2010) J. Biopharm. Stat. , vol.20 , Issue.20 , pp. 75-89
    • Hsieh, T.C.1    Chow, S.C.2    Liu, J.P.3    Hsiao, C.F.4    Chi, E.5
  • 137
    • 84872387242 scopus 로고    scopus 로고
    • The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics
    • Hsieh, T.C., Chow, S.C., Yang, L.Y., and Chi, E. (2013). The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. Stat. Med., 32, 406–414.
    • (2013) Stat. Med. , vol.32 , pp. 406-414
    • Hsieh, T.C.1    Chow, S.C.2    Yang, L.Y.3    Chi, E.4
  • 138
    • 12244264188 scopus 로고    scopus 로고
    • Some fundamental issues with non-inferiority testing in active controlled trials
    • Hung, H.M.J., Wang, S.J., Tsong, Y., Lawrence, J., and O’Neil, R.T. (2003). Some fundamental issues with non-inferiority testing in active controlled trials. Stat. Med., 22, 213–225.
    • (2003) Stat. Med. , vol.22 , pp. 213-225
    • Hung, H.M.J.1    Wang, S.J.2    Tsong, Y.3    Lawrence, J.4    O’Neil, R.T.5
  • 139
    • 0034735561 scopus 로고    scopus 로고
    • A small-sample confidence interval approach to assess individual bioequivalence
    • Hyslop, T., Hsuan, F., and Holder, K.J. (2000). A small-sample confidence interval approach to assess individual bioequivalence. Stat. Med., 19, 2885–2897.
    • (2000) Stat. Med. , vol.19 , pp. 2885-2897
    • Hyslop, T.1    Hsuan, F.2    Holder, K.J.3
  • 140
    • 85054732767 scopus 로고
    • Tripartite International Conference on Harmonization Guideline, Q1A, Geneva, Switzerland
    • ICH. (1993). Stability testing of new drug substances and products. Tripartite International Conference on Harmonization Guideline, Q1A, Geneva, Switzerland.
    • (1993) Stability Testing of New Drug Substances and Products
  • 142
    • 0009756580 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD
    • ICH. (1997). Guidance for industry—S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD.
    • (1997) Guidance for industry—S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
  • 143
    • 0011476837 scopus 로고    scopus 로고
    • E5 guideline on ethnic factors in acceptability of foreign data
    • ICH. (1998). E5 guideline on ethnic factors in acceptability of foreign data. The U.S. Federal Register, 83, 31790–31796.
    • (1998) The U.S. Federal Register , vol.83 , pp. 31790-31796
  • 144
    • 0003582181 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD
    • ICH. (1999). Q6B guideline on test procedures and acceptance criteria for biotechnological/biological products. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD.
    • (1999) Q6B Guideline on Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
  • 146
    • 27144478295 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD, November 2003
    • ICH. (2003). Guidance for industry. Q1A(R2) stability testing of new drug substances and products. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD, November 2003.
    • (2003) Guidance for Industry. Q1A(R2) Stability Testing of New Drug Substances and Products
  • 148
    • 26844482505 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD, June 2004
    • ICH. (2004). Guidance for industry. Q1E evaluation of stability data. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the U.S. Food and Drug Administration, Rockville, MD, June 2004.
    • (2004) Guidance for Industry. Q1E Evaluation of Stability Data
  • 150
    • 0029155006 scopus 로고
    • On stability designs in drug shelf-life estimation
    • Ju, H.L. and Chow, S.C. (1995). On stability designs in drug shelf-life estimation. J. Biopharm. Stat., 5, 210–214.
    • (1995) J. Biopharm. Stat. , vol.5 , pp. 210-214
    • Ju, H.L.1    Chow, S.C.2
  • 151
    • 84872403675 scopus 로고    scopus 로고
    • Statistical assessment of biosimilarity based on relative distance between follow-on biologics
    • Kang, S.H. and Chow, S.C. (2013). Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Stat. Med., 32, 382–392.
    • (2013) Stat. Med. , vol.32 , pp. 382-392
    • Kang, S.H.1    Chow, S.C.2
  • 152
    • 6344293527 scopus 로고    scopus 로고
    • Novel scaled average bioequivalence limits based on GMR and variability considerations
    • Karalis, V., Symillides, M., and Macheras, P. (2004). Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm. Res., 21, 1933–1942.
    • (2004) Pharm. Res. , vol.21 , pp. 1933-1942
    • Karalis, V.1    Symillides, M.2    Macheras, P.3
  • 153
    • 6344293527 scopus 로고    scopus 로고
    • Novel scaled average bioequivalence limits based on GMR and variability considerations
    • Karalis, V., Symillides, M., and Macheras, P. (2004). Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm. Res., 21, 1933–1942.
    • (2004) Pharm. Res. , vol.21 , pp. 1933-1942
    • Karalis, V.1    Symillides, M.2    Macheras, P.3
  • 154
    • 77951638082 scopus 로고    scopus 로고
    • Comparability of biotechnological/biological products subject to changes in their manufacturing
    • Kendrick, B.S., Chrimes, G., Cockrill, S.L., Gabrielson, J.P., Arthur, K.K. et al. (2009). Comparability of biotechnological/biological products subject to changes in their manufacturing. BioPharm Int., 22, 32–44.
    • (2009) Biopharm Int , vol.22 , pp. 32-44
    • Kendrick, B.S.1    Chrimes, G.2    Cockrill, S.L.3    Gabrielson, J.P.4    Arthur, K.K.5
  • 157
    • 12344270270 scopus 로고    scopus 로고
    • Assessing surrogated as trial end-points using mixed models
    • Korn, E.L., Albert, P.S., and McShane, L.M. (2005). Assessing surrogated as trial end-points using mixed models, Stat. Med., 24, 163–182.
    • (2005) Stat. Med. , vol.24 , pp. 163-182
    • Korn, E.L.1    Albert, P.S.2    McShane, L.M.3
  • 158
    • 75649145776 scopus 로고    scopus 로고
    • FDA policy on follow on biologics
    • George Washington University, Washington, DC
    • Kozlowski, S. (2007). FDA policy on follow on biologics. Proceedings of the Biosimilars 2007, George Washington University, Washington, DC.
    • (2007) Proceedings of the Biosimilars 2007
    • Kozlowski, S.1
  • 159
    • 33748687181 scopus 로고    scopus 로고
    • The protein science of biosimilars
    • Kuhlmann, M. and Covic, A. (2006). The protein science of biosimilars. Nephrol. Dial. Transplant., 21, Suppl 5: v4–v8.
    • (2006) Nephrol. Dial. Transplant. , vol.21 , pp. v4-v8
    • Kuhlmann, M.1    Covic, A.2
  • 161
    • 0037472846 scopus 로고    scopus 로고
    • Non-inferiority trials: The ‘at least as good as’ criterion
    • Laster, L.L. and Johnson, M.F. (2003). Non-inferiority trials: the ‘at least as good as’ criterion. Stat. Med., 22, 187–200.
    • (2003) Stat. Med. , vol.22 , pp. 187-200
    • Laster, L.L.1    Johnson, M.F.2
  • 162
    • 35848970587 scopus 로고    scopus 로고
    • Identifying potential immunodominant positions and predicting antigenic variants of influenza A/H3N2 viruses
    • Lee, M.S., Chen, M.C., Liao, Y.C., and Hsiung, A.G. (2007). Identifying potential immunodominant positions and predicting antigenic variants of influenza A/H3N2 viruses. Vaccine, 25, 8133–8139.
    • (2007) Vaccine , vol.25 , pp. 8133-8139
    • Lee, M.S.1    Chen, M.C.2    Liao, Y.C.3    Hsiung, A.G.4
  • 163
    • 3543007739 scopus 로고    scopus 로고
    • Predicting antigenic variants of influenza A/H3N2 viruses
    • Lee, M.S. and Chen, M.C. (2004). Predicting antigenic variants of influenza A/H3N2 viruses. Emerg. Infect. Dis., 10, 1385–1390.
    • (2004) Emerg. Infect. Dis. , vol.10 , pp. 1385-1390
    • Lee, M.S.1    Chen, M.C.2
  • 164
    • 2942536762 scopus 로고    scopus 로고
    • Modified large-sample confidence intervals for linear combinations of variance components: Extension, theory, and application
    • Lee, Y., Shao, J., and Chow, S.C. (2004). Modified large-sample confidence intervals for linear combinations of variance components: Extension, theory, and application. J. Am. Stat. Assoc., 99, 467–478.
    • (2004) J. Am. Stat. Assoc. , vol.99 , pp. 467-478
    • Lee, Y.1    Shao, J.2    Chow, S.C.3
  • 165
    • 0036448950 scopus 로고    scopus 로고
    • Test for inter-subject and total vari-abilities under crossover designs
    • Lee, Y., Shao, J., Chow, S.C., and Wang, H. (2002). Test for inter-subject and total vari-abilities under crossover designs. J. Biopharm. Stat., 12, 503–534.
    • (2002) J. Biopharm. Stat. , vol.12 , pp. 503-534
    • Lee, Y.1    Shao, J.2    Chow, S.C.3    Wang, H.4
  • 166
    • 0029166760 scopus 로고
    • In vitro/in vivo correlation
    • Leeson, L.J. (1995). In vitro/in vivo correlation. Drug Inform. J., 29, 903–915.
    • (1995) Drug Inform. J. , vol.29 , pp. 903-915
    • Leeson, L.J.1
  • 167
    • 75649121048 scopus 로고    scopus 로고
    • Evaluating statistical methods to establish clinical similarity of two biologics
    • Lei, L. and Olson, K. (2010). Evaluating statistical methods to establish clinical similarity of two biologics. J. Biopharm. Stat., 20, 62–74.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 62-74
    • Lei, L.1    Olson, K.2
  • 168
    • 0003139708 scopus 로고
    • Contributions to Probability and Statistics. Olkin, I., Ed. Stanford University Press, Palo Alto, CA
    • Levene, H. (1960). Robust tests for the equality of variances. In: Contributions to Probability and Statistics. Olkin, I., Ed. Stanford University Press, Palo Alto, CA, pp. 278–292.
    • (1960) Robust Tests for the Equality of Variances , pp. 278-292
    • Levene, H.1
  • 169
    • 85054721969 scopus 로고
    • A presentation to the U.S. Food and Drug Administration Heaving on Bioequivalence of Solid Oral Dosage Forms, September 29–October 1, Pharmaceutical Manufacturer Association, Section II
    • Levy, N.W. (1986). Bioequivalence of Solid oral dosage forms. A presentation to the U.S. Food and Drug Administration Heaving on Bioequivalence of Solid Oral Dosage Forms, September 29–October 1, Pharmaceutical Manufacturer Association, Section II, pp. 9–11.
    • (1986) ). Bioequivalence of Solid Oral Dosage Forms. , pp. 9-11
    • Levy, N.W.1
  • 170
    • 84872371168 scopus 로고    scopus 로고
    • Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins
    • Li, Y., Liu, Q., Wood, P., and Johri, A. (2013). Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins. Stat. Med., 32, 393–405.
    • (2013) Stat. Med. , vol.32 , pp. 393-405
    • Li, Y.1    Liu, Q.2    Wood, P.3    Johri, A.4
  • 171
    • 34547842196 scopus 로고    scopus 로고
    • Regulating follow-on biologics
    • Liang, B.A. (2007). Regulating follow-on biologics. Harvard J. Legis., 44, 363–373.
    • (2007) Harvard J. Legis. , vol.44 , pp. 363-373
    • Liang, B.A.1
  • 172
    • 84872404773 scopus 로고    scopus 로고
    • Comparability of critical quality attributes for establishing biosimilarity
    • Liao, J.J.Z. and Darken, P.F. (2013). Comparability of critical quality attributes for establishing biosimilarity. Stat. Med., 32, 462–469.
    • (2013) Stat. Med. , vol.32 , pp. 462-469
    • Liao, J.J.Z.1    Darken, P.F.2
  • 173
    • 84867036086 scopus 로고    scopus 로고
    • Biosimilarity for follow-on biologics
    • Liao, J.J.Z and Heyse, J.F. (2011). Biosimilarity for follow-on biologics. Stat. Biopharm. Res., 3, 445–455.
    • (2011) Stat. Biopharm. Res. , vol.3 , pp. 445-455
    • Liao, J.J.Z.1    Heyse, J.F.2
  • 174
    • 39149126039 scopus 로고    scopus 로고
    • Bioinformatics models for predicting variants of influenza A/H3N2 viruses
    • Liao, Y.C., Lee, M.S., Ko, C.Y., and Hsiung, C.A. (2008). Bioinformatics models for predicting variants of influenza A/H3N2 viruses. Bioinformatics, 24, 505–512.
    • (2008) Bioinformatics , vol.24 , pp. 505-512
    • Liao, Y.C.1    Lee, M.S.2    Ko, C.Y.3    Hsiung, C.A.4
  • 175
    • 85054756623 scopus 로고    scopus 로고
    • PERI Course: Non-Clinical Statistics for Drug Discovery and Development, Arlington, VI, March 1997
    • Lin, D. (1997). Stability studies at the FDA. PERI Course: Non-Clinical Statistics for Drug Discovery and Development, Arlington, VI, March 1997.
    • (1997) Stability Studies at the FDA
    • Lin, D.1
  • 176
    • 84872397773 scopus 로고    scopus 로고
    • Application of the parallel line assay to assessment of biosimilar products based on binary end-points
    • Lin, J.R., Chow, S.C., Chang, C.H., Lin, Y.C., and Liu, J.P. (2013). Application of the parallel line assay to assessment of biosimilar products based on binary end-points. Stat. Med., 32, 449–461.
    • (2013) Stat. Med. , vol.32 , pp. 449-461
    • Lin, J.R.1    Chow, S.C.2    Chang, C.H.3    Lin, Y.C.4    Liu, J.P.5
  • 179
    • 0005362710 scopus 로고    scopus 로고
    • Statistical evaluation of individual bioequivalence
    • Liu, J.P. (1998). Statistical evaluation of individual bioequivalence. Commun. Stat.: Theory Methods, 27, 1433–1451.
    • (1998) Commun. Stat.: Theory Methods , vol.27 , pp. 1433-1451
    • Liu, J.P.1
  • 180
    • 73949142341 scopus 로고    scopus 로고
    • Inference on treatment effects for targeted clinical trials under enrichment design
    • published on line
    • Liu, J.P., Lin, J.R., and Chow, S.C. (2009). Inference on treatment effects for targeted clinical trials under enrichment design. Pharm. Stat., published on line. DOI: 10.1002/pst.364.
    • (2009) Pharm. Stat.
    • Liu, J.P.1    Lin, J.R.2    Chow, S.C.3
  • 181
    • 84950182824 scopus 로고
    • On assessment of bioequivalence in variability of bioavailability
    • Liu, J.P. and Chow, S.C. (1992). On assessment of bioequivalence in variability of bioavailability. Comm. Stat. Theory Methods, 21, 2591–2608.
    • (1992) Comm. Stat. Theory Methods , vol.21 , pp. 2591-2608
    • Liu, J.P.1    Chow, S.C.2
  • 182
    • 37549027260 scopus 로고    scopus 로고
    • Statistical issues on the diagnostic multivariate index assay and targeted clinical trials
    • Liu, J.P. and Chow, S.C. (2008). Statistical issues on the diagnostic multivariate index assay and targeted clinical trials, J. Biopharm. Stat., 18, 167–182.
    • (2008) J. Biopharm. Stat. , vol.18 , pp. 167-182
    • Liu, J.P.1    Chow, S.C.2
  • 183
    • 65449172786 scopus 로고    scopus 로고
    • Statistical methods for targeted clinical trials under enrichment design
    • Liu, J.P. and Lin, J.R. (2008). Statistical methods for targeted clinical trials under enrichment design. J. Formosan Med. Assoc., 107, S34–S41.
    • (2008) J. Formosan Med. Assoc. , vol.107 , pp. S34-S41
    • Liu, J.P.1    Lin, J.R.2
  • 184
    • 0026581741 scopus 로고
    • Estimation of direct formulation effect under log-normal distribution in bioavailability/bioequivalence studies
    • Liu, J.P. and Weng, C.S. (1992). Estimation of direct formulation effect under log-normal distribution in bioavailability/bioequivalence studies. Stat. Med., 11, 881–896.
    • (1992) Stat. Med. , vol.11 , pp. 881-896
    • Liu, J.P.1    Weng, C.S.2
  • 185
    • 84963186067 scopus 로고
    • Estimation of log-transformation in assessing bioequivalence
    • Liu, J.P. and Weng, C.S. (1994). Estimation of log-transformation in assessing bioequivalence. Comm. Stat. Theory Methods, 23, 421–434.
    • (1994) Comm. Stat. Theory Methods , vol.23 , pp. 421-434
    • Liu, J.P.1    Weng, C.S.2
  • 186
    • 0029006314 scopus 로고
    • Bias of two one-sided tests procedures in assessment of bioequivalence
    • Liu, J.P. and Weng, C.S. (1995). Bias of two one-sided tests procedures in assessment of bioequivalence. Stat. Med., 14, 853–861.
    • (1995) Stat. Med. , vol.14 , pp. 853-861
    • Liu, J.P.1    Weng, C.S.2
  • 187
    • 0030696078 scopus 로고    scopus 로고
    • 2 as a criterion for assessment of similarity between dissolution profiles
    • 2 as a criterion for assessment of similarity between dissolution profiles. Drug Inf. J., 31, 1255–1271.
    • (1997) Drug Inf. J. , vol.31 , pp. 1255-1271
    • Liu, J.P.1    Ma, M.C.2    Chow, S.C.3
  • 188
    • 34247849335 scopus 로고    scopus 로고
    • Target practice: Lessons from phase III trials with bevacizumab and vatalanib in the treatment of advanced colorectal cancer
    • Los, M., Roodhart, J.M., and Voest, E.E. (2007). Target practice: Lessons from phase III trials with bevacizumab and vatalanib in the treatment of advanced colorectal cancer. Oncologist, 12, 443–450.
    • (2007) Oncologist , vol.12 , pp. 443-450
    • Los, M.1    Roodhart, J.M.2    Voest, E.E.3
  • 189
    • 34548815955 scopus 로고    scopus 로고
    • Statistical quality control process for traditional Chinese medicine with multiple correlative components
    • Lu, Q., Chow, S.C., and Tse, S.K. (2007). Statistical quality control process for traditional Chinese medicine with multiple correlative components. J. Biopharm. Stat., 17, 791–808.
    • (2007) J. Biopharm. Stat. , vol.17 , pp. 791-808
    • Lu, Q.1    Chow, S.C.2    Tse, S.K.3
  • 190
    • 70449638011 scopus 로고    scopus 로고
    • On assessing bioequivalence using genomic data with model misspecification
    • Lu, Q., Tse, S.K., Chow, S.C., and Yang, J. (2009). On assessing bioequivalence using genomic data with model misspecification. J. Biopharm. Stat., 19, 571–579.
    • (2009) J. Biopharm. Stat. , vol.19 , pp. 571-579
    • Lu, Q.1    Tse, S.K.2    Chow, S.C.3    Yang, J.4
  • 191
    • 0033271186 scopus 로고    scopus 로고
    • Statistical evaluation of dissolution similarity
    • Ma, M.C., Lin, R.P., and Liu, J.P. (1999). Statistical evaluation of dissolution similarity. Stat. Sin., 9, 1011–1027.
    • (1999) Stat. Sin. , vol.9 , pp. 1011-1027
    • Ma, M.C.1    Lin, R.P.2    Liu, J.P.3
  • 192
    • 0002322469 scopus 로고
    • On a test of whether one or two random variables is stochastically larger than the other
    • Mann, H.B. and Whitney, D.R. (1947). On a test of whether one or two random variables is stochastically larger than the other. Ann. Math. Stat., 18, 50–60.
    • (1947) Ann. Math. Stat. , vol.18 , pp. 50-60
    • Mann, H.B.1    Whitney, D.R.2
  • 193
    • 85054759888 scopus 로고    scopus 로고
    • Presented at NCI Biological Resources Branch Workshop “Working with FDA: Biological Products and Clinical Development”. National Cancer Institute, Bethesda, MD
    • Markovic, I. (2007). Chemistry, manufacturing and control issues in production of therapeutic biologic protein products. Presented at NCI Biological Resources Branch Workshop “Working with FDA: Biological Products and Clinical Development”. National Cancer Institute, Bethesda, MD.
    • (2007) Chemistry, Manufacturing and Control Issues in Production of Therapeutic Biologic Protein Products
    • Markovic, I.1
  • 195
    • 79952744875 scopus 로고    scopus 로고
    • Worldwide experience with biosimilar development
    • McCamish, M. and Woollett, G. (2011). Worldwide experience with biosimilar development. mAbs, 3, 209–217.
    • (2011) Mabs , vol.3 , pp. 209-217
    • McCamish, M.1    Woollett, G.2
  • 196
    • 85054766479 scopus 로고    scopus 로고
    • Guidelines for the quality, safety and efficacy assurance of follow-on biologics (Yakushoku shinsahatu 0304007). Japan
    • MHLW. (2009). Guidelines for the quality, safety and efficacy assurance of follow-on biologics (Yakushoku shinsahatu 0304007). Japan.
    • (2009)
  • 197
    • 2342652446 scopus 로고    scopus 로고
    • Mathematical comparison of curves with an emphasis on dissolution profiles
    • Moore, J.W. and Flanner, H.H. (1996). Mathematical comparison of curves with an emphasis on dissolution profiles. Pharm. Technol., 20, 64–74.
    • (1996) Pharm. Technol. , vol.20 , pp. 64-74
    • Moore, J.W.1    Flanner, H.H.2
  • 198
    • 0002829661 scopus 로고
    • A test for the significance of the difference between the two variances in a sample from a normal bivariate population
    • Morgan, W.A. (1939). A test for the significance of the difference between the two variances in a sample from a normal bivariate population. Biometrika, 31, 13–19.
    • (1939) Biometrika , vol.31 , pp. 13-19
    • Morgan, W.A.1
  • 199
    • 0030476130 scopus 로고    scopus 로고
    • Uniform matrix stability study designs
    • Murphy, J.R. (1996). Uniform matrix stability study designs. J. Biopharm. Stat., 6, 477–494.
    • (1996) J. Biopharm. Stat. , vol.6 , pp. 477-494
    • Murphy, J.R.1
  • 202
    • 0027027294 scopus 로고
    • Statistical comparison of stability study designs
    • Nordbrock, E. (1992). Statistical comparison of stability study designs. J. Biopharm. Stat.. 2, 91–113.
    • (1992) J. Biopharm. Stat. , vol.2 , pp. 91-113
    • Nordbrock, E.1
  • 203
    • 85054749305 scopus 로고
    • PERI: Training Course in Non-Clinical Statistics, Dallas, TX, February 1994
    • Nordbrock, E. (1994a). Computing power details. PERI: Training Course in Non-Clinical Statistics, Dallas, TX, February 1994.
    • (1994) Computing Power Details
    • Nordbrock, E.1
  • 206
    • 85054738170 scopus 로고    scopus 로고
    • Stability matrix designs
    • 2nd Edn., Ed. Chow, S.C., Marcel Dekker, Inc., New York
    • Nordbrock, E. (2003). Stability matrix designs. In Encyclopedia of Biopharmaceutical Statistics, 2nd Edn., Ed. Chow, S.C., Marcel Dekker, Inc., New York, pp. 934–939.
    • (2003) Encyclopedia of Biopharmaceutical Statistics , pp. 934-939
    • Nordbrock, E.1
  • 207
    • 85054711734 scopus 로고    scopus 로고
    • Use of statistics to establish a stability trend: Matrixing
    • Kim Kuynh-Ba Ed. Springer, New York
    • Nordbrock, E. (2009). Use of statistics to establish a stability trend: Matrixing. In: Pharmaceutical Testing to Support Global Markets. Kim Kuynh-Ba Ed. Springer, New York, 2009.
    • (2009) Pharmaceutical Testing to Support Global Markets , pp. 2009
    • Nordbrock, E.1
  • 209
    • 0006075504 scopus 로고
    • A special case of a noncentral t distribution
    • Owen, D.B. (1965). A special case of a noncentral t distribution. Biometrika, 52, 437–446.
    • (1965) Biometrika , vol.52 , pp. 437-446
    • Owen, D.B.1
  • 210
    • 0642360504 scopus 로고
    • Maximum variance of order statistics
    • Papadatos, N. (1995). Maximum variance of order statistics. Ann. Inst. Stat. Math, 47, l85–193.
    • (1995) Ann. Inst. Stat. Math , vol.47 , pp. 185-193
    • Papadatos, N.1
  • 211
    • 84963178184 scopus 로고
    • Dose-response in pharmacokinetics
    • Patel, H.I. (1994). Dose-response in pharmacokinetics. Comm. Stat. Theory Methods, 23, 451–465.
    • (1994) Comm. Stat. Theory Methods , vol.23 , pp. 451-465
    • Patel, H.I.1
  • 212
    • 0025334006 scopus 로고
    • Power of the two one-sided tests procedure in bioequivalence
    • Phillips, K.F. (1990). Power of the two one-sided tests procedure in bioequivalence. J. Pharm. Biopharm., 18, 137–144.
    • (1990) J. Pharm. Biopharm. , vol.18 , pp. 137-144
    • Phillips, K.F.1
  • 213
    • 0037472812 scopus 로고    scopus 로고
    • A new test of non-inferiority for anti-infective trials
    • Phillips, K.F. (2003). A new test of non-inferiority for anti-infective trials. Stat. Med., 22, 201–212.
    • (2003) Stat. Med. , vol.22 , pp. 201-212
    • Phillips, K.F.1
  • 214
    • 85054749158 scopus 로고    scopus 로고
    • Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland
    • PIC/S. (2009). Guide to Good Manufacturing Practice for Switzerland Annexes. Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland.
    • (2009) Guide to Good Manufacturing Practice for Switzerland Annexes.
  • 215
    • 0002363710 scopus 로고
    • A note on normal correlation
    • Pitman, E.J.G. (1939). A note on normal correlation. Biometrika, 31, 9–12.
    • (1939) Biometrika , vol.31 , pp. 9-12
    • Pitman, E.J.G.1
  • 217
    • 0033819066 scopus 로고    scopus 로고
    • Comparison of bracketing and matrixing designs for a two-year stability study
    • Pong, A. and Raghavarao, D. (2000). Comparison of bracketing and matrixing designs for a two-year stability study, J. Biopharm. Stat., 10, 217–228.
    • (2000) J. Biopharm. Stat. , vol.10 , pp. 217-228
    • Pong, A.1    Raghavarao, D.2
  • 218
    • 0030449210 scopus 로고    scopus 로고
    • Assessing reproducibility by the within-subject coefficient of variation with random effects models
    • Quan, H. and Shih, W.J. (1996). Assessing reproducibility by the within-subject coefficient of variation with random effects models. Biometrics, 52, 1195–1203.
    • (1996) Biometrics , vol.52 , pp. 1195-1203
    • Quan, H.1    Shih, W.J.2
  • 219
    • 0036199096 scopus 로고    scopus 로고
    • Bad medicine: Why the generic drug regulatory paradigm is inapplicable to biotechnology products
    • Raines, L.J. (2002). Bad medicine: Why the generic drug regulatory paradigm is inapplicable to biotechnology products. Biolaw. Bus., 5, 6–13.
    • (2002) Biolaw. Bus. , vol.5 , pp. 6-13
    • Raines, L.J.1
  • 220
    • 0018976518 scopus 로고
    • Determining the probability of an important difference in bioavailability
    • Rodda, B.E. and Davis, R.L. (1980). Determining the probability of an important difference in bioavailability. Clin. Pharmacol. Ther., 28, 247–252.
    • (1980) Clin. Pharmacol. Ther. , vol.28 , pp. 247-252
    • Rodda, B.E.1    Davis, R.L.2
  • 221
    • 33746169811 scopus 로고    scopus 로고
    • Biosimilars: How similar or dissimilar are they?
    • Roger, S.D. (2006). Biosimilars: How similar or dissimilar are they? Nephrology, 11, 341–346.
    • (2006) Nephrology , vol.11 , pp. 341-346
    • Roger, S.D.1
  • 222
    • 34848844984 scopus 로고    scopus 로고
    • Biosimilars: Opportunity or cause for concern?
    • Roger, S.D. and Mikhail, A. (2007). Biosimilars: Opportunity or cause for concern? J. Pharm. Sci., 10, 405–410.
    • (2007) J. Pharm. Sci. , vol.10 , pp. 405-410
    • Roger, S.D.1    Mikhail, A.2
  • 223
    • 33644834827 scopus 로고    scopus 로고
    • Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies
    • Sargent, D.F., Wieand, S., Haller, D.G. et al. (2005). Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies. J. Clin. Oncol., 23, 8864–8670.
    • (2005) J. Clin. Oncol. , vol.23 , pp. 8864
    • Sargent, D.F.1    Wieand, S.2    Haller, D.G.3
  • 224
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • Schall, R. and Luus, H.G. (1993). On population and individual bioequivalence. Stat. Med., 12, 1109–1124.
    • (1993) Stat. Med. , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, H.G.2
  • 225
    • 0042009405 scopus 로고    scopus 로고
    • Relationship between biopharmaceutical immunogenicity of epoetin alfa and pure red cell aplasia
    • Schellekens, H. (2003). Relationship between biopharmaceutical immunogenicity of epoetin alfa and pure red cell aplasia. Curr. Med. Res. Opin., 19, 433–434.
    • (2003) Curr. Med. Res. Opin. , vol.19 , pp. 433-434
    • Schellekens, H.1
  • 226
    • 8344222959 scopus 로고    scopus 로고
    • How similar do ‘biosimilar’ need to be?
    • Schellekens, H. (2004). How similar do ‘biosimilar’ need to be? Nat. Biotechnol., 22, 1357–1359.
    • (2004) Nat. Biotechnol. , vol.22 , pp. 1357-1359
    • Schellekens, H.1
  • 227
    • 19044395847 scopus 로고    scopus 로고
    • Follow-on biologics: Challenges of the “next generation
    • Schellekens, H. (2005). Follow-on biologics: Challenges of the “next generation.” Nephrol. Dial. Transplant., 20(Suppl 4), 31–36.
    • (2005) Nephrol. Dial. Transplant. , vol.20 , pp. 31-36
    • Schellekens, H.1
  • 228
    • 0000117116 scopus 로고
    • On hypothesis testing to determine if the mean of a normal distribution is continued in a known interval
    • Schuirmann, D.J. (1981). On hypothesis testing to determine if the mean of a normal distribution is continued in a known interval. Biometrics, 37, 617.
    • (1981) Biometrics , vol.37 , pp. 617
    • Schuirmann, D.J.1
  • 229
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann, D.J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm., 15, 657–680.
    • (1987) J. Pharmacokinet. Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 232
    • 17444453579 scopus 로고    scopus 로고
    • Evaluation of orally administered highly variable drugs and drug formulations
    • Shah, V.P., Yacobi, A., Barr, W.H. et al. (1996). Evaluation of orally administered highly variable drugs and drug formulations. Pharm. Res., 13, 1590–1594.
    • (1996) Pharm. Res. , vol.13 , pp. 1590-1594
    • Shah, V.P.1    Yacobi, A.2    Barr, W.H.3
  • 233
    • 0031006172 scopus 로고    scopus 로고
    • Prediction bounds for random shelf-lives
    • Shao, J. and Chen, L. (1997). Prediction bounds for random shelf-lives. Stat. Med., 16, 1167–1173.
    • (1997) Stat. Med. , vol.16 , pp. 1167-1173
    • Shao, J.1    Chen, L.2
  • 234
    • 0027994758 scopus 로고
    • Statistical inference in stability analysis
    • Shao, J. and Chow, S.C. (1994). Statistical inference in stability analysis. Biometrics, 50, 753–763.
    • (1994) Biometrics , vol.50 , pp. 753-763
    • Shao, J.1    Chow, S.C.2
  • 235
    • 0037198999 scopus 로고    scopus 로고
    • Reproducibility probability in clinical trials
    • Shao, J. and Chow, S.C. (2002). Reproducibility probability in clinical trials. Stat. Med., 21, 17727–1742.
    • (2002) Stat. Med. , vol.21 , pp. 17727-21742
    • Shao, J.1    Chow, S.C.2
  • 236
    • 79959647129 scopus 로고    scopus 로고
    • Market access of biosimilars: Not only a cost issue
    • Simoens, S., Verbeken, G., and Huys, I. (2011). Market access of biosimilars: Not only a cost issue. Oncologie, 13(5), 218–221.
    • (2011) Oncologie , vol.13 , Issue.5 , pp. 218-221
    • Simoens, S.1    Verbeken, G.2    Huys, I.3
  • 237
    • 80053573008 scopus 로고    scopus 로고
    • Regulatory guideline for biosimilar products in Korea
    • Suh, S.K. and Park, Y. (2011). Regulatory guideline for biosimilar products in Korea. Biologicals, 39, 336–338.
    • (2011) Biologicals , vol.39 , pp. 336-338
    • Suh, S.K.1    Park, Y.2
  • 238
    • 85054763553 scopus 로고
    • The United States Food and Drug Administration Guideline Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Rockville, MD
    • SUPAC-IR. (1995). The United States Food and Drug Administration Guideline Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Rockville, MD.
    • (1995)
  • 239
    • 0002068388 scopus 로고
    • Confidence intervals on linear combinations of variance components that are unrestricted in sign
    • Ting, N., Burdick, R.K., Graybill, F.A., Jeyaratnam, S., and Lu, T.-F.C. (1990). Confidence intervals on linear combinations of variance components that are unrestricted in sign. J. Stat. Comput. Simul., 35, 135–143.
    • (1990) J. Stat. Comput. Simul. , vol.35 , pp. 135-143
    • Ting, N.1    Burdick, R.K.2    Graybill, F.A.3    Jeyaratnam, S.4    Lu, T.-F.C.5
  • 240
    • 85054750644 scopus 로고    scopus 로고
    • FDA response to house subcommittee on health
    • FDA, Rockville, MD, September 2008
    • Torti, F. (2008). FDA response to house subcommittee on health. Letter to the House on biosimilar issues. FDA, Rockville, MD, September 2008.
    • (2008) Letter to the House on Biosimilar Issues.
    • Torti, F.1
  • 241
    • 70349970382 scopus 로고    scopus 로고
    • Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence
    • Tothfalusi, L., Endrenyi, L., and Arieta, A.G. (2009). Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin. Pharmacokinet., 48, 725–743.
    • (2009) Clin. Pharmacokinet. , vol.48 , pp. 725-743
    • Tothfalusi, L.1    Endrenyi, L.2    Arieta, A.G.3
  • 242
    • 0034865996 scopus 로고    scopus 로고
    • Evaluation of the bioequivalence of highly variable drugs and drug products
    • Tothfalusi, L., Endrenyi, L., Midha, K.K., Rawson, M.J., and Hubbard, J.W. (2001). Evaluation of the bioequivalence of highly variable drugs and drug products. Pharm. Res., 18, 728–733.
    • (2001) Pharm. Res. , vol.18 , pp. 728-733
    • Tothfalusi, L.1    Endrenyi, L.2    Midha, K.K.3    Rawson, M.J.4    Hubbard, J.W.5
  • 243
    • 37249091680 scopus 로고    scopus 로고
    • Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets
    • Tothfalusi, L., Speidl, S., and Endrenyi, L. (2008). Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets. Br. J. Clin. Pharmacol., 65, 110–122.
    • (2008) Br. J. Clin. Pharmacol. , vol.65 , pp. 110-122
    • Tothfalusi, L.1    Speidl, S.2    Endrenyi, L.3
  • 244
    • 0037337782 scopus 로고    scopus 로고
    • Limits for the scaled average bioequivalence of highly variable drugs and drug products
    • Tothfalusi, L. and Endrenyi, L. (2003). Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm. Res., 20, 382–389.
    • (2003) Pharm. Res. , vol.20 , pp. 382-389
    • Tothfalusi, L.1    Endrenyi, L.2
  • 245
    • 33750882700 scopus 로고    scopus 로고
    • Statistical quality control process for traditional Chinese medicine
    • Tse, S.K., Chang, J.Y., Su, W.L., Chow, S.C., Hsiung, C., and Lu, Q. (2006). Statistical quality control process for traditional Chinese medicine. J. Biopharm. Stat., 16, 861–874.
    • (2006) J. Biopharm. Stat. , vol.16 , pp. 861-874
    • Tse, S.K.1    Chang, J.Y.2    Su, W.L.3    Chow, S.C.4    Hsiung, C.5    Lu, Q.6
  • 246
    • 0041663355 scopus 로고    scopus 로고
    • ANCOVA approach for shelf life analysis of stability study of multiple factor designs
    • Tsong, Y., Chen, W.J., and Chen, C.W. (2008). ANCOVA approach for shelf life analysis of stability study of multiple factor designs. J. Biopharm. Stat., 13, 375–393.
    • (2008) J. Biopharm. Stat. , vol.13 , pp. 375-393
    • Tsong, Y.1    Chen, W.J.2    Chen, C.W.3
  • 248
    • 79960011508 scopus 로고    scopus 로고
    • A consistency approach to evaluation of bridging studies and multiregional trials
    • Tsou, H.H., Chien, T.Y., Liu, J.P., and Hsiao, C.F. (2011). A consistency approach to evaluation of bridging studies and multiregional trials. Stat. Med., 30, 2171–2186.
    • (2011) Stat. Med. , vol.30 , pp. 2171-2186
    • Tsou, H.H.1    Chien, T.Y.2    Liu, J.P.3    Hsiao, C.F.4
  • 250
    • 84860285348 scopus 로고    scopus 로고
    • On regulatory approval pathway of biosimilar products
    • Wang, J. and Chow, S.C. (2012). On regulatory approval pathway of biosimilar products. Pharmaceuticals, 5, 353–368.
    • (2012) Pharmaceuticals , vol.5 , pp. 353-368
    • Wang, J.1    Chow, S.C.2
  • 251
    • 75649135221 scopus 로고    scopus 로고
    • Development of biosimilars—Pharmacokinetic and pharmacodynamic considerations
    • Wang, Y.M. and Chow, A.T. (2010). Development of biosimilars—Pharmacokinetic and pharmacodynamic considerations. J. Biopharm. Stat., 20, 46–61.
    • (2010) J. Biopharm. Stat. , vol.20 , pp. 46-61
    • Wang, Y.M.1    Chow, A.T.2
  • 257
    • 0001884644 scopus 로고
    • Individual comparisons by ranking methods
    • Wilcoxon, F. (1945). Individual comparisons by ranking methods. Biometrics, 1, 80–83.
    • (1945) Biometrics , vol.1 , pp. 80-83
    • Wilcoxon, F.1
  • 259
    • 34447503942 scopus 로고    scopus 로고
    • The FDA’s assessment of follow-on protein products: A historical perspective
    • Woodcock, J. (2007). The FDA’s assessment of follow-on protein products: A historical perspective. Nat. Rev. Drug Discov., 6, 437–442.
    • (2007) Nat. Rev. Drug Discov. , vol.6 , pp. 437-442
    • Woodcock, J.1
  • 260
    • 34447503942 scopus 로고    scopus 로고
    • The FDA’s assessment of follow-on protein products: A historical perspective
    • Woodcock, J., Griffin, J., Behrman, R. et al. (2007). The FDA’s assessment of follow-on protein products: A historical perspective. Nat. Rev. Drug Discov., 6, 437–442.
    • (2007) Nat. Rev. Drug Discov. , vol.6 , pp. 437-442
    • Woodcock, J.1    Griffin, J.2    Behrman, R.3
  • 261
    • 84872402838 scopus 로고    scopus 로고
    • An extended F-test for heterogeneity of variability in follow-on biological products
    • Yang, J., Zhang, N., Chow, S.C., and Chi, E. (2013). An extended F-test for heterogeneity of variability in follow-on biological products. Stat. Med., 32, 415–423.
    • (2013) Stat. Med. , vol.32 , pp. 415-423
    • Yang, J.1    Zhang, N.2    Chow, S.C.3    Chi, E.4
  • 262
    • 84872418710 scopus 로고    scopus 로고
    • Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics
    • Zhang, N., Yang, J., Chow, S.C., Endrenyi, L., and Chi, E. (2013). Impact of variability on the choice of biosimilarity limits in assessing follow-on biologics. Stat. Med., 32, 424–433.
    • (2013) Stat. Med. , vol.32 , pp. 424-433
    • Zhang, N.1    Yang, J.2    Chow, S.C.3    Endrenyi, L.4    Chi, E.5


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