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Volumn 15, Issue 1, 2011, Pages 73-84

Sample sizes for designing bioequivalence studies for highly variable drugs

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; COMPUTER PROGRAM; COMPUTER SIMULATION; CONTROLLED STUDY; EUROPEAN MEDICINE AGENCY; FOOD AND DRUG ADMINISTRATION; GEOMETRIC MEAN RATIO; HEALTH CARE ORGANIZATION; MATHEMATICAL COMPUTING; MATHEMATICS; OBSERVER VARIATION; SAMPLE SIZE; STATISTICAL ANALYSIS;

EID: 84856186304     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (56)

References (16)
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    • Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence
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    • Tothfalusi, L.1    Endrenyi, L.2    Garcia Areta, A.3
  • 2
    • 67649932264 scopus 로고    scopus 로고
    • European Medicines Agency, London, United Kingdom, January 20
    • European Medicines Agency. Guideline on the investigation of bioequivalence. London, United Kingdom, January 20, 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.p df.
    • (2010) Guideline on the investigation of bioequivalence
  • 4
    • 0034865996 scopus 로고    scopus 로고
    • Evaluation of the bioequivalence of highly-variable drugs and drug products
    • L. Tothfalusi, L. Endrenyi, K.K. Midha, M.J. Rawson, and J.W. Hubbard. Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm. Res. 18: 728-733 (2001).
    • (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
  • 5
    • 0025334006 scopus 로고
    • Power of the two one-sided tests procedure in bioequivalence
    • K. F. Phillips. Power of the two one-sided tests procedure in bioequivalence. J. Pharmacokin. Biopharm. 18: 137-144 (1990).
    • (1990) J. Pharmacokin. Biopharm. , vol.18 , pp. 137-144
    • Phillips, K.F.1
  • 6
    • 0025958371 scopus 로고
    • Sample size determination for bioequivalence assessment by means of confidence intervals
    • E. Diletti E, D. Hauschke, and V. W. Steinijans. Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Pharm. Ther. Toxicol. 29: 1-8 (1991).
    • (1991) Int. J. Pharm. Ther. Toxicol. , vol.29 , pp. 1-8
    • Diletti, E.E.1    Hauschke, D.2    Steinijans, V.W.3
  • 7
    • 0027097542 scopus 로고
    • Sample size determination for bioequivalence assessment using a multiplicative model
    • D. Hauschke, V. W. Steinijans, E. Diletti, and M. Burke. Sample size determination for bioequivalence assessment using a multiplicative model. J. Pharmacokin. Biopharm. 20: 557-561 (1992).
    • (1992) J. Pharmacokin. Biopharm. , vol.20 , pp. 557-561
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3    Burke, M.4
  • 8
    • 0026711141 scopus 로고
    • Sample size determination for the two one-sided test procedure in bioequivalence
    • J. P. Liu and S. C. Chow. Sample size determination for the two one-sided test procedure in bioequivalence. J. Pharmacokin. Biopharm. 20: 101-104 (1992).
    • (1992) J. Pharmacokin. Biopharm. , vol.20 , pp. 101-104
    • Liu, J.P.1    Chow, S.C.2
  • 10
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach assessing the equivalence of average bioavailability
    • D. Schuirmann. A comparison of the two one-sided tests procedure and the power approach assessing the equivalence of average bioavailability. J. Pharmacokin. Biopharm. 15: 657-680 (1987).
    • (1987) J. Pharmacokin. Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.1
  • 11
    • 0029567034 scopus 로고
    • An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs
    • A.W. Boddy, F.C. Snikeris, R.O. Kringle, G.C.G. Wei, J.A. Opperman, and K.K. Midha. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm. Res. 12: 1865-1868 (1995).
    • (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
  • 12
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    • Limits for the scaled average bioequivalence of highly variable drugs and drug products
    • L. Tothfalusi, and L. Endrenyi. Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm. Res. 20: 382-389 (2003).
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    • Tothfalusi, L.1    Endrenyi, L.2
  • 13
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    • http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209294.pdf
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    • Regulatory conditions for the determination of bioequivalence of highly variable drugs
    • L. Endrenyi and L. Tothfalusi. Regulatory conditions for the determination of bioequivalence of highly variable drugs. J. Pharm. Pharmaceut. Sci. 12: 138-149 (2009).
    • (2009) J. Pharm. Pharmaceut. Sci. , vol.12 , pp. 138-149
    • Endrenyi, L.1    Tothfalusi, L.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.