个体生物等效性。生物等效性指标统计评估中的新概念。美国食品药品监督管理局个体生物等效性工作组 - Suppr

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超能文献

Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.

作者信息

Patnaik R N, Lesko L J, Chen M L, Williams R L

机构信息

Division of Bioequivalence, Food and Drug Administration, Rockville, Maryland, USA.

出版信息

Clin Pharmacokinet. 1997 Jul;33(1):1-6. doi: 10.2165/00003088-199733010-00001.

DOI:10.2165/00003088-199733010-00001

PMID:9250419

Abstract

摘要

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Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.个体生物等效性。生物等效性指标统计评估中的新概念。美国食品药品监督管理局个体生物等效性工作组

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本文引用的文献

Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41.

The assessment of individual and population bioequivalence.

J Biopharm Stat. 1996 Mar;6(1):1-14. doi: 10.1080/10543409608835118.

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.

Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals.基于容忍区间法评估个体生物等效性时的样本量考量

Int J Clin Pharmacol Ther. 1994 Jan;32(1):26-32.

Extension to the use of tolerance intervals for the assessment of individual bioequivalence.用于评估个体生物等效性的容许区间使用的扩展。

J Biopharm Stat. 1994 Mar;4(1):39-52. doi: 10.1080/10543409408835071.

A method for the evaluation of individual bioequivalence.一种个体生物等效性的评估方法。

Int J Clin Pharmacol Ther. 1994 Sep;32(9):497-508.

Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar.利用生物利用度相似的概率评估个体和群体生物等效性。

Biometrics. 1995 Jun;51(2):615-26.

Measuring switchability and prescribability: when is average bioequivalence sufficient?衡量可转换性和可处方性：平均生物等效性何时足够？

J Pharmacokinet Biopharm. 1994 Dec;22(6):551-64. doi: 10.1007/BF02353794.

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.

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.

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