Literature DB >> 6747820

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

W W Hauck, S Anderson.   

Abstract

The clinical problem of testing for equivalence in comparative bioavailability trials is restated in terms of the proper statistical hypotheses. A simple t-test procedure for these hypotheses has been developed that is more powerful than the methods based on usual (shortest) and symmetric confidence intervals. In this note, this new procedure is explained and an example is given, including the method for sample size determination.

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Year:  1984        PMID： 6747820     DOI： 10.1007/BF01063612

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


  7 in total

1.  Symmetrical confidence intervals for bioequivalence trials.

Authors:  W J Westlake
Journal:  Biometrics       Date:  1976-12       Impact factor: 2.571

2.  Bioavailability--a problem in equivalence.

Authors:  C M Metzler
Journal:  Biometrics       Date:  1974-06       Impact factor: 2.571

3.  Use of confidence intervals in analysis of comparative bioavailability trials.

Authors:  W J Westlake
Journal:  J Pharm Sci       Date:  1972-08       Impact factor: 3.534

4.  Significance testing to establish equivalence between treatments, with special reference to data in the form of 2X2 tables.

Authors:  C W Dunnett; M Gent
Journal:  Biometrics       Date:  1977-12       Impact factor: 2.571

5.  Comparison of different methods for decision-making in bioequivalence assessment.

Authors:  D Mandallaz; J Mau
Journal:  Biometrics       Date:  1981-06       Impact factor: 2.571

6.  A Bayesian approach to bioequivalence for the 2 x 2 changeover design.

Authors:  M R Selwyn; A P Dempster; N R Hall
Journal:  Biometrics       Date:  1981-03       Impact factor: 2.571

7.  The bioavailability of erythromycin stearate versus enteric-coated erythromycin base when taken immediately before and after food.

Authors:  D Clayton; A Leslie
Journal:  J Int Med Res       Date:  1981       Impact factor: 1.671
  7 in total
  35 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

2.  Comparative bioavailability of two different rectal preparations of piroxicam in man.

Authors:  S Benkö; G Grézal; E Nagy; I Klebovich
Journal:  Eur J Clin Pharmacol       Date:  1992       Impact factor: 2.953

3.  Comparative bioavailability study of two brands of prazosin-containing tablets in healthy volunteers.

Authors:  P J Guelen; T J Janssen; M H Lam; T B Vree; P S Exler
Journal:  Pharm Weekbl Sci       Date:  1990-10-19

4.  Estimating physical activity using a cell phone questionnaire sent by means of short message service (SMS): a randomized population-based study.

Authors:  Ylva Trolle Lagerros; Sven Sandin; Christin Bexelius; Jan-Eric Litton; Marie Löf
Journal:  Eur J Epidemiol       Date:  2012-06-29       Impact factor: 8.082

5.  Spline functions in convolutional modeling of verapamil bioavailability and bioequivalence. II: study in healthy volunteers.

Authors:  J Popović; R Mitić; A Sabo; M Mikov; V Jakovljević; K Daković-Svajcer
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2006 Apr-Jun       Impact factor: 2.441

6.  Consideration of individual bioequivalence.

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

7.  Considerations in the attainment of steady state: aggregate vs. individual assessment.

Authors:  W W Hauck; T N Tozer; S Anderson; F Y Bois
Journal:  Pharm Res       Date:  1998-11       Impact factor: 4.200

Review 8.  Bioequivalence assessment of generic drugs: an American point of view.

Authors:  R Patnaik; L J Lesko; K Chan; R L Williams
Journal:  Eur J Drug Metab Pharmacokinet       Date:  1996 Apr-Jun       Impact factor: 2.441

Review 9.  Review of methods and criteria for the evaluation of bioequivalence studies.

Authors:  G Pabst; H Jaeger
Journal:  Eur J Clin Pharmacol       Date:  1990       Impact factor: 2.953

10.  Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).

Authors:  Margherita Torti; Jhessica Alessandroni; Daniele Bravi; Miriam Casali; Paola Grassini; Chiara Fossati; Cristiano Ialongo; Marco Onofrj; Fabiana Giada Radicati; Laura Vacca; Stefano Bonassi; Fabrizio Stocchi
Journal:  Br J Clin Pharmacol       Date:  2019-09-12       Impact factor: 4.335
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