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Volumn 34, Issue 1, 2008, Pages 66-77

A new principal component analysis-based approach for testing "similarity" of drug dissolution profiles

Author keywords

Acetaminophen; Dissolution profiles; Furosemide; Multivariate method; Principal component analysis; Similarity test

Indexed keywords

FUROSEMIDE; PARACETAMOL;

EID: 42649113374     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2008.02.009     Document Type: Article
Times cited : (60)

References (43)
  • 2
    • 0037006610 scopus 로고    scopus 로고
    • Principal component analysis of dissolution data with missing elements
    • Adams E., Walczak B., Vervaet C., Risha P.G., and Massart D.L. Principal component analysis of dissolution data with missing elements. Int. J. Pharm. 234 (2002) 169-178
    • (2002) Int. J. Pharm. , vol.234 , pp. 169-178
    • Adams, E.1    Walczak, B.2    Vervaet, C.3    Risha, P.G.4    Massart, D.L.5
  • 3
    • 0030976225 scopus 로고    scopus 로고
    • Multiple-time-point dissolution specifications for a sampling acceptance plan
    • Chen J.J., and Tsong Y. Multiple-time-point dissolution specifications for a sampling acceptance plan. J. Biopharm. Stat. 7 (1997) 259-270
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 259-270
    • Chen, J.J.1    Tsong, Y.2
  • 4
    • 0036429995 scopus 로고    scopus 로고
    • On the assessment of similarity for dissolution profiles of two drug products
    • Chow S.-C., and Shao J. On the assessment of similarity for dissolution profiles of two drug products. J. Biopharm. Stat. 12 (2002) 311-321
    • (2002) J. Biopharm. Stat. , vol.12 , pp. 311-321
    • Chow, S.-C.1    Shao, J.2
  • 5
    • 0035073301 scopus 로고    scopus 로고
    • Modelling and comparison of dissolution profiles
    • Costa P., and Sousa Lobo J.M. Modelling and comparison of dissolution profiles. Eur. J. Pharm. Sci. 13 (2001) 123-133
    • (2001) Eur. J. Pharm. Sci. , vol.13 , pp. 123-133
    • Costa, P.1    Sousa Lobo, J.M.2
  • 7
    • 42649123427 scopus 로고    scopus 로고
    • Eaton, M.L., Muirhead, R.J., Steeno, G.S., 2003. Biopharmaceutical Report, Winter. Biopharmaceutical Section, American Statistical Association 11, 2-7.
    • Eaton, M.L., Muirhead, R.J., Steeno, G.S., 2003. Biopharmaceutical Report, Winter. Biopharmaceutical Section, American Statistical Association 11, 2-7.
  • 8
    • 84964203940 scopus 로고
    • Bootstrap methods for standard errors, confidence intervals and other measures of statistical accuracy
    • Efron B., and Tibshirani R.J. Bootstrap methods for standard errors, confidence intervals and other measures of statistical accuracy. Stat. Sci. 1 (1986) 54-77
    • (1986) Stat. Sci. , vol.1 , pp. 54-77
    • Efron, B.1    Tibshirani, R.J.2
  • 10
    • 0344019460 scopus 로고    scopus 로고
    • Dissolution specifications based on release rates
    • Elkoshi Z. Dissolution specifications based on release rates. J. Pharm. Sci. 88 (1999) 434-444
    • (1999) J. Pharm. Sci. , vol.88 , pp. 434-444
    • Elkoshi, Z.1
  • 11
    • 0027436487 scopus 로고
    • Multiple layer, direct compression controlled release system: in vitro and in vivo evaluation
    • Fassihi R.A., and Ritschel W.A. Multiple layer, direct compression controlled release system: in vitro and in vivo evaluation. J. Pharm. Sci. 82 (1993) 750-754
    • (1993) J. Pharm. Sci. , vol.82 , pp. 750-754
    • Fassihi, R.A.1    Ritschel, W.A.2
  • 12
    • 42649110434 scopus 로고    scopus 로고
    • Food and Drug Administration, 1995. FDA Guidance for Industry: Immediate Release Solid Dosage Forms: Scale-up and Post Approval Changes (SUPAC-IR). Chemistry, manufacturing and controls, In vitro dissolution testing and in vivo bioequivalence documentation. Rockville, MD.
    • Food and Drug Administration, 1995. FDA Guidance for Industry: Immediate Release Solid Dosage Forms: Scale-up and Post Approval Changes (SUPAC-IR). Chemistry, manufacturing and controls, In vitro dissolution testing and in vivo bioequivalence documentation. Rockville, MD.
  • 13
    • 23044533713 scopus 로고    scopus 로고
    • Application of a recurrent neural network to prediction of drug dissolution profiles
    • Goh W.Y., Lim C.P., Peh K.K., and Subari K. Application of a recurrent neural network to prediction of drug dissolution profiles. Neural Comp. Appl. 10 (2002) 311-317
    • (2002) Neural Comp. Appl. , vol.10 , pp. 311-317
    • Goh, W.Y.1    Lim, C.P.2    Peh, K.K.3    Subari, K.4
  • 14
    • 0037361032 scopus 로고    scopus 로고
    • Predicting drug dissolution profiles with an ensemble of boosted neural networks: a timeseries approach
    • Goh W.Y., Lim C.P., and Peh K.K. Predicting drug dissolution profiles with an ensemble of boosted neural networks: a timeseries approach. IEEE Trans. Neural Net. 14 (2003) 459-463
    • (2003) IEEE Trans. Neural Net. , vol.14 , pp. 459-463
    • Goh, W.Y.1    Lim, C.P.2    Peh, K.K.3
  • 15
    • 0030874214 scopus 로고    scopus 로고
    • Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vivo/in vitro correlation using a two-phase dissolution test
    • Grundy J.S., Anderson K.E., Rogers J.A., and Foster R.T. Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vivo/in vitro correlation using a two-phase dissolution test. J. Control. Release 48 (1997) 9-17
    • (1997) J. Control. Release , vol.48 , pp. 9-17
    • Grundy, J.S.1    Anderson, K.E.2    Rogers, J.A.3    Foster, R.T.4
  • 16
    • 42649100703 scopus 로고    scopus 로고
    • Human Medicines Evaluation Unit, 1999. Note For Guidance on quality of modified release products: A. Oral dosage forms; B. Transdermal dosage forms; Section I (Quality), EMEA, CPMP/QWP/604/96.
    • Human Medicines Evaluation Unit, 1999. Note For Guidance on quality of modified release products: A. Oral dosage forms; B. Transdermal dosage forms; Section I (Quality), EMEA, CPMP/QWP/604/96.
  • 18
    • 33144471121 scopus 로고    scopus 로고
    • Partial least square projections to latent structures analysis (PLS) in evaluating and predicting drug release from starch acetate matrix tablets
    • Korhonen O., Matero S., Poso A., and Ketolainen J. Partial least square projections to latent structures analysis (PLS) in evaluating and predicting drug release from starch acetate matrix tablets. J. Pharm. Sci. 94 (2005) 2716-2730
    • (2005) J. Pharm. Sci. , vol.94 , pp. 2716-2730
    • Korhonen, O.1    Matero, S.2    Poso, A.3    Ketolainen, J.4
  • 19
    • 0029166760 scopus 로고
    • In vitro/in vivo correlations
    • Leeson L.J. In vitro/in vivo correlations. Drug Inf. J. 29 (1995) 903-915
    • (1995) Drug Inf. J. , vol.29 , pp. 903-915
    • Leeson, L.J.1
  • 20
    • 27744476933 scopus 로고    scopus 로고
    • Application of the Gaussian mixture model to drug dissolution profiles prediction
    • Lim C.P., Quek S.S., and Peh K.K. Application of the Gaussian mixture model to drug dissolution profiles prediction. Neural Comp. Appl. 14 (2005) 345-352
    • (2005) Neural Comp. Appl. , vol.14 , pp. 345-352
    • Lim, C.P.1    Quek, S.S.2    Peh, K.K.3
  • 21
    • 0030696078 scopus 로고    scopus 로고
    • Multiple-time-point dissolution specifications for a sampling acceptance plan
    • Liu J.P., Ma M.-C., and Chow S.-C. Multiple-time-point dissolution specifications for a sampling acceptance plan. Drug Inf. J. 31 (1997) 1255-1271
    • (1997) Drug Inf. J. , vol.31 , pp. 1255-1271
    • Liu, J.P.1    Ma, M.-C.2    Chow, S.-C.3
  • 22
    • 0033271186 scopus 로고    scopus 로고
    • Statistical evaluation of dissolution similarity
    • Ma M.-C., Lin R.P., and Liu J.P. Statistical evaluation of dissolution similarity. Stat. Sin. 9 (1999) 1011-1028
    • (1999) Stat. Sin. , vol.9 , pp. 1011-1028
    • Ma, M.-C.1    Lin, R.P.2    Liu, J.P.3
  • 23
    • 0033823162 scopus 로고    scopus 로고
    • Assessment of similarity between dissolution profiles
    • Ma M.-C., Wang B.B.C., Liu J.-P., and Tsong Y. Assessment of similarity between dissolution profiles. J. Biopharm. Stat. 10 (2000) 229-249
    • (2000) J. Biopharm. Stat. , vol.10 , pp. 229-249
    • Ma, M.-C.1    Wang, B.B.C.2    Liu, J.-P.3    Tsong, Y.4
  • 26
    • 2342652446 scopus 로고    scopus 로고
    • Mathematical comparison of curves with an emphasis on in-vitro dissolution profiles
    • Moore J.W., and Flanner H.H. Mathematical comparison of curves with an emphasis on in-vitro dissolution profiles. Pharm. Technol. 20 (1996) 64-74
    • (1996) Pharm. Technol. , vol.20 , pp. 64-74
    • Moore, J.W.1    Flanner, H.H.2
  • 27
    • 0028915087 scopus 로고
    • In vitro-in vivo correlation studies on a novel controlled release theophylline delivery system and on Theo-Dur tablets
    • Munday D.L., and Fassihi R.A. In vitro-in vivo correlation studies on a novel controlled release theophylline delivery system and on Theo-Dur tablets. Int. J. Pharm. 118 (1995) 251-255
    • (1995) Int. J. Pharm. , vol.118 , pp. 251-255
    • Munday, D.L.1    Fassihi, R.A.2
  • 28
    • 0027263353 scopus 로고
    • Comparison of the mechanism of dissolution of hydrocortisone in simple and mixed micelle systems
    • Naylor L.J., Bakatselou V., and Dressman J.B. Comparison of the mechanism of dissolution of hydrocortisone in simple and mixed micelle systems. Pharm. Res. 10 (1993) 865-870
    • (1993) Pharm. Res. , vol.10 , pp. 865-870
    • Naylor, L.J.1    Bakatselou, V.2    Dressman, J.B.3
  • 30
    • 0034495109 scopus 로고    scopus 로고
    • Use of artificial neural networks to predict drug dissolution profiles and evaluation of network performance using similarity factor
    • Peh K.K., Lim C.P., Quek S.S., and Khoh K.H. Use of artificial neural networks to predict drug dissolution profiles and evaluation of network performance using similarity factor. Pharm. Res. 17 (2000) 1384-1388
    • (2000) Pharm. Res. , vol.17 , pp. 1384-1388
    • Peh, K.K.1    Lim, C.P.2    Quek, S.S.3    Khoh, K.H.4
  • 31
    • 0029828547 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles
    • Polli J.E., Rekhi G.S., and Shah V.P. Methods to compare dissolution profiles. Drug Inf. J. 30 (1996) 1113-1120
    • (1996) Drug Inf. J. , vol.30 , pp. 1113-1120
    • Polli, J.E.1    Rekhi, G.S.2    Shah, V.P.3
  • 32
    • 0030926727 scopus 로고    scopus 로고
    • Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets
    • Polli J.E., Rekhi G.S., Augsburger J.J., and Shah V.P. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. J. Pharm. Sci. 86 (1997) 690-700
    • (1997) J. Pharm. Sci. , vol.86 , pp. 690-700
    • Polli, J.E.1    Rekhi, G.S.2    Augsburger, J.J.3    Shah, V.P.4
  • 33
    • 15544386651 scopus 로고    scopus 로고
    • A multivariate test for similarity of two dissolution profiles
    • Saranadasa H., and Krishnamoorthy K. A multivariate test for similarity of two dissolution profiles. J. Biopharm. Stat. 15 (2005) 265-278
    • (2005) J. Biopharm. Stat. , vol.15 , pp. 265-278
    • Saranadasa, H.1    Krishnamoorthy, K.2
  • 35
    • 0001201102 scopus 로고
    • Statistical issues in drug quality control based on dissolution testing
    • American Statistical Association
    • Tsong Y., and Hammerstrom T. Statistical issues in drug quality control based on dissolution testing. Proceedings of the Biopharmaceutical Section. American Statistical Association (1994) 295-300
    • (1994) Proceedings of the Biopharmaceutical Section , pp. 295-300
    • Tsong, Y.1    Hammerstrom, T.2
  • 37
    • 0029825719 scopus 로고    scopus 로고
    • Statistical assessment of mean difference between two dissolution data sets
    • Tsong Y., Hammerstrom T., Sathe P., and Shah V.P. Statistical assessment of mean difference between two dissolution data sets. Drug Inf. J. 30 (1996) 1105-1112
    • (1996) Drug Inf. J. , vol.30 , pp. 1105-1112
    • Tsong, Y.1    Hammerstrom, T.2    Sathe, P.3    Shah, V.P.4
  • 38
    • 0030738943 scopus 로고    scopus 로고
    • Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis
    • Tsong Y., Hammerstrom T., and Chen J.J. Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis. J. Biopharm. Stat. 7 (1997) 423-439
    • (1997) J. Biopharm. Stat. , vol.7 , pp. 423-439
    • Tsong, Y.1    Hammerstrom, T.2    Chen, J.J.3
  • 39
    • 42649119179 scopus 로고    scopus 로고
    • USP Convention, 2007. The United States Pharmacopoeia 30. The National Formulary 25, Rockville, MD.
    • USP Convention, 2007. The United States Pharmacopoeia 30. The National Formulary 25, Rockville, MD.
  • 40
    • 0026077977 scopus 로고
    • Development of new control release formulation of chlorpheniramine maleate using in-vitro, in-vivo correlation
    • Williams R.L., Upton R.A., Ball L., Braun R.L., Lin E.T., Liang-Gee W., and Leeson L.J. Development of new control release formulation of chlorpheniramine maleate using in-vitro, in-vivo correlation. J. Pharm. Sci. 80 (1991) 22-25
    • (1991) J. Pharm. Sci. , vol.80 , pp. 22-25
    • Williams, R.L.1    Upton, R.A.2    Ball, L.3    Braun, R.L.4    Lin, E.T.5    Liang-Gee, W.6    Leeson, L.J.7
  • 42
    • 0029991598 scopus 로고    scopus 로고
    • Theophylline controlled-release formulations: in vivo-in vitro correlations
    • Yu Z., Schwartz J.B., and Sugita E.T. Theophylline controlled-release formulations: in vivo-in vitro correlations. Biopharm. Drug Dispos. 17 (1996) 259-272
    • (1996) Biopharm. Drug Dispos. , vol.17 , pp. 259-272
    • Yu, Z.1    Schwartz, J.B.2    Sugita, E.T.3
  • 43
    • 0034687583 scopus 로고    scopus 로고
    • Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods
    • Yuksel N., Kanik A.E., and Baykara T. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int. J. Pharm. 209 (2000) 57-67
    • (2000) Int. J. Pharm. , vol.209 , pp. 57-67
    • Yuksel, N.1    Kanik, A.E.2    Baykara, T.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.