Literature DB >> 2348380

Power of the two one-sided tests procedure in bioequivalence.

K F Phillips1.   

Abstract

The power of the two one-sided tests procedure for testing bioequivalence is derived from the bivariate noncentral t distribution. Power curves are shown and their use in planning bioequivalence experiments discussed. Sample sizes computed in the usual manner from an analysis of variance are shown to be too small to assure a declaration of bioequivalence except under favorable conditions.

Mesh：

Year:  1990        PMID： 2348380     DOI： 10.1007/bf01063556

Source DB:  PubMed          Journal:  J Pharmacokinet Biopharm        ISSN： 0090-466X


  2 in total

1.  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

2.  A new statistical procedure for testing equivalence in two-group comparative bioavailability trials.

Authors:  W W Hauck; S Anderson
Journal:  J Pharmacokinet Biopharm       Date:  1984-02
  2 in total
  18 in total

1.  Sample size calculation in bioequivalence trials.

Authors:  Peter Blood
Journal:  J Pharmacokinet Pharmacodyn       Date:  2002-02       Impact factor: 2.745

2.  Sample size determination for bioequivalence assessment using a multiplicative model.

Authors:  D Hauschke; V W Steinijans; E Diletti; M Burke
Journal:  J Pharmacokinet Biopharm       Date:  1992-10

3.  Sample size determination for the two one-sided tests procedure in bioequivalence.

Authors:  J P Liu; S C Chow
Journal:  J Pharmacokinet Biopharm       Date:  1992-02

Review 4.  Controversies in bioequivalence studies.

Authors:  V W Steinijans; D Hauschke; J H Jonkman
Journal:  Clin Pharmacokinet       Date:  1992-04       Impact factor: 6.447

5.  Using statistical equivalence testing in clinical biofeedback research.

Authors:  J P Hatch
Journal:  Biofeedback Self Regul       Date:  1996-06

6.  A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Authors:  Wenlei Jiang; Fairouz Makhlouf; Donald J Schuirmann; Xinyuan Zhang; Nan Zheng; Dale Conner; Lawrence X Yu; Robert Lionberger
Journal:  AAPS J       Date:  2015-04-04       Impact factor: 4.009

7.  Sample size determination in bioequivalence studies using statistical assurance.

Authors:  A Ring; B Lang; C Kazaroho; D Labes; R Schall; H Schütz
Journal:  Br J Clin Pharmacol       Date:  2019-08-13       Impact factor: 4.335

Review 8.  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

9.  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

10.  Sample sizes for comparative inhaled corticosteroid trials with emphasis on showing therapeutic equivalence.

Authors:  P Zanen; J W Lammers
Journal:  Eur J Clin Pharmacol       Date:  1995       Impact factor: 2.953
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