Literature DB >> 9250419

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

R N Patnaik1, L J Lesko, M L Chen, R L Williams.   

Abstract

Mesh：

Year:  1997        PMID： 9250419     DOI： 10.2165/00003088-199733010-00001

Source DB:  PubMed          Journal:  Clin Pharmacokinet        ISSN： 0312-5963            Impact factor:   6.447


× No keyword cloud information.
  13 in total

Review 1.  Types of bioequivalence and related statistical considerations.

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

2.  Consideration of individual bioequivalence.

Authors:  S Anderson; W W Hauck
Journal:  J Pharmacokinet Biopharm       Date:  1990-06

3.  The assessment of individual and population bioequivalence.

Authors:  V M Chinchilli
Journal:  J Biopharm Stat       Date:  1996-03       Impact factor: 1.051

4.  Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group.

Authors:  W W Hauck; M L Chen; T Hyslop; R Patnaik; D Schuirmann; R Williams
Journal:  Int J Clin Pharmacol Ther       Date:  1996-12       Impact factor: 1.366

5.  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.  Measuring switchability and prescribability: when is average bioequivalence sufficient?

Authors:  W W Hauck; S Anderson
Journal:  J Pharmacokinet Biopharm       Date:  1994-12

Review 7.  Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals.

Authors:  J D Esinhart; V M Chinchilli
Journal:  Int J Clin Pharmacol Ther       Date:  1994-01       Impact factor: 1.366

8.  On population and individual bioequivalence.

Authors:  R Schall; H G Luus
Journal:  Stat Med       Date:  1993-06-30       Impact factor: 2.373

9.  A method for the evaluation of individual bioequivalence.

Authors:  L Endrenyi
Journal:  Int J Clin Pharmacol Ther       Date:  1994-09       Impact factor: 1.366

10.  Bioequivalence and interchangeability.

Authors:  S Hwang; P B Huber; M Hesney; K C Kwan
Journal:  J Pharm Sci       Date:  1978-06       Impact factor: 3.534
View more
  16 in total

1.  Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. FDA Population/Individual Bioequivalence Working Group. Food and Drug Administration.

Authors:  W W Hauck; T Hyslop; M L Chen; R Patnaik; R L Williams
Journal:  Pharm Res       Date:  2000-04       Impact factor: 4.200

Review 2.  Individual bioequivalence revisited.

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

3.  Subject-by-formulation interaction in determinations of individual bioequivalence: bias and prevalence.

Authors:  L Endrenyi; L Tothfalusi
Journal:  Pharm Res       Date:  1999-02       Impact factor: 4.200

4.  Limits for the scaled average bioequivalence of highly variable drugs and drug products.

Authors:  Laszlo Tothfalusi; Laszlo Endrenyi
Journal:  Pharm Res       Date:  2003-03       Impact factor: 4.200

5.  Bioequivalence of highly variable drugs: a comparison of the newly proposed regulatory approaches by FDA and EMA.

Authors:  Vangelis Karalis; Mira Symillides; Panos Macheras
Journal:  Pharm Res       Date:  2011-12-28       Impact factor: 4.200

6.  Novel scaled average bioequivalence limits based on GMR and variability considerations.

Authors:  Vangelis Karalis; Mira Symillides; Panos Macheras
Journal:  Pharm Res       Date:  2004-10       Impact factor: 4.200

Review 7.  Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence.

Authors:  Laszlo Tothfalusi; Laszlo Endrenyi; Alfredo Garcia Arieta
Journal:  Clin Pharmacokinet       Date:  2009       Impact factor: 6.447

Review 8.  Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization.

Authors:  Laszlo Endrenyi; Laszlo Tothfalusi
Journal:  J Pharmacokinet Pharmacodyn       Date:  2019-02-23       Impact factor: 2.745

Review 9.  Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.

Authors:  Barbara M Davit; Mei-Ling Chen; Dale P Conner; Sam H Haidar; Stephanie Kim; Christina H Lee; Robert A Lionberger; Fairouz T Makhlouf; Patrick E Nwakama; Devvrat T Patel; Donald J Schuirmann; Lawrence X Yu
Journal:  AAPS J       Date:  2012-09-13       Impact factor: 4.009

10.  Inflation of the type I error: investigations on regulatory recommendations for bioequivalence of highly variable drugs.

Authors:  Meinolf Wonnemann; Cornelia Frömke; Armin Koch
Journal:  Pharm Res       Date:  2014-07-18       Impact factor: 4.200
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.