Literature DB >> 11032083

The basis for individual bioequivalence. FDA Population and Individual Bioequivalence Working Group.

R L Williams1, R N Patnaik, M L Chen.   

Abstract

Mesh：

Year:  2000        PMID： 11032083     DOI： 10.1007/BF03190050

Source DB:  PubMed          Journal:  Eur J Drug Metab Pharmacokinet        ISSN： 0378-7966            Impact factor:   2.441


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  6 in total

Review 1.  PhRMA perspective on population and individual bioequivalence.

Authors:  J S Barrett; V Batra; A Chow; J Cook; A L Gould; A H Heller; M W Lo; S D Patterson; B P Smith; J A Stritar; J M Vega; N Zariffa
Journal:  J Clin Pharmacol       Date:  2000-06       Impact factor: 3.126

2.  Bioequivalence of methylphenidate immediate-release tablets using a replicated study design to characterize intrasubject variability.

Authors:  M C Meyer; A B Straughn; E J Jarvi; K S Patrick; F R Pelsor; R L Williams; R Patnaik; M L Chen; V P Shah
Journal:  Pharm Res       Date:  2000-04       Impact factor: 4.200

3.  Bioequivalence revisited.

Authors:  L B Sheiner
Journal:  Stat Med       Date:  1992-09-30       Impact factor: 2.373

Review 4.  Types of bioequivalence and related statistical considerations.

Authors:  W W Hauck; S Anderson
Journal:  Int J Clin Pharmacol Ther Toxicol       Date:  1992-05

5.  Individual bioequivalence: attractive in principle, difficult in practice.

Authors:  L Endrenyi; G L Amidon; K K Midha; J P Skelly
Journal:  Pharm Res       Date:  1998-09       Impact factor: 4.200

6.  A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.

Authors:  D J Schuirmann
Journal:  J Pharmacokinet Biopharm       Date:  1987-12
  6 in total
  3 in total

Review 1.  Individual bioequivalence revisited.

Authors:  M L Chen; L J Lesko
Journal:  Clin Pharmacokinet       Date:  2001       Impact factor: 6.447

2.  Spline functions in convolutional modeling of verapamil bioavailability and bioequivalence. I: conceptual and numerical issues.

Authors:  J Popović
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2006 Apr-Jun       Impact factor: 2.441

3.  Individualized, discrete event, simulations provide insight into inter- and intra-subject variability of extended-release, drug products.

Authors:  Sean H J Kim; Andre J Jackson; Rim Hur; C Anthony Hunt
Journal:  Theor Biol Med Model       Date:  2012-08-31       Impact factor: 2.432
  3 in total

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