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Bioequivalence assessment of generic drugs: an American point of view.

作者信息

Patnaik R, Lesko L J, Chan K, Williams R L

机构信息

Office of Pharmaceutical Science, Food and Drug Administration, Rockville, Maryland 20855, USA.

出版信息

Eur J Drug Metab Pharmacokinet. 1996 Apr-Jun;21(2):159-64. doi: 10.1007/BF03190265.

DOI:10.1007/BF03190265
PMID:8839690
Abstract
摘要

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Bioequivalence testing of a new tablet formulation of generic fluoxetine.通用型氟西汀新片剂配方的生物等效性测试。
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Individualizing therapy - in search of approaches to maximize the benefit of drug treatment (II).个体化治疗——探寻最大化药物治疗益处的方法(二)
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本文引用的文献

1
On population and individual bioequivalence.论群体生物等效性与个体生物等效性
Stat Med. 1993 Jun 30;12(12):1109-24. doi: 10.1002/sim.4780121202.
2
Bioequivalence: performance of several measures of rate of absorption.生物等效性:几种吸收速率测量指标的表现
Pharm Res. 1994 Jul;11(7):966-74. doi: 10.1023/a:1018970901116.
3
BIO-international '94 Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies and Pre-Conference Satellite on 'In Vivo/In Vitro Correlation'. Munich, Germany, June 14-17, 1994.
J Interv Card Electrophysiol. 1999 Jul;3(2):145-7. doi: 10.1023/a:1009817413845.
4
Management of narrow therapeutic index drugs.窄治疗指数药物的管理
J Thromb Thrombolysis. 1999 Apr;7(2):137-43. doi: 10.1023/a:1008829403320.
5
Cubic spline functions and polynomials for calculation of absorption rate.用于计算吸收速率的三次样条函数和多项式。
Eur J Drug Metab Pharmacokinet. 1998 Oct-Dec;23(4):469-73. doi: 10.1007/BF03189997.
Eur J Drug Metab Pharmacokinet. 1995 Jan-Mar;20(1):3-13. doi: 10.1007/BF03192283.
4
A new statistical procedure for testing equivalence in two-group comparative bioavailability trials.一种用于两组比较生物利用度试验中检验等效性的新统计方法。
J Pharmacokinet Biopharm. 1984 Feb;12(1):83-91. doi: 10.1007/BF01063612.
5
Sex-related differences in drug disposition in man.人类药物处置中的性别差异。
Clin Pharmacokinet. 1984 May-Jun;9(3):189-202. doi: 10.2165/00003088-198409030-00001.
6
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.两种单侧检验方法与评估平均生物利用度等效性的效能法的比较。
J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
7
Clinical pharmacokinetic considerations in the elderly. An update.老年人的临床药代动力学考量。最新进展。
Clin Pharmacokinet. 1989 Oct;17(4):236-63. doi: 10.2165/00003088-198917040-00003.
8
Consideration of individual bioequivalence.个体生物等效性的考量。
J Pharmacokinet Biopharm. 1990 Jun;18(3):259-73. doi: 10.1007/BF01062202.
9
Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.在生物等效性研究中,对于吸收速率而言,Cmax/AUC比Cmax是更清晰的衡量指标。
Int J Clin Pharmacol Ther Toxicol. 1991 Oct;29(10):394-9.
10
Controversies in bioequivalence studies.生物等效性研究中的争议
Clin Pharmacokinet. 1992 Apr;22(4):247-53. doi: 10.2165/00003088-199222040-00001.