Literature DB >> 11419963

Bioequivalent or nonbioequivalent?

A Rescigno1, J Powers, E E Herderick.   

Abstract

The current tests for bioequivalence are based on assumptions that are not valid in general; this paper shows why it is necessary to use a method that does not depend upon assumptions that cannot, and need not, be proved in general. Copyright 2001 Academic Press.

Mesh：

Year:  2001        PMID： 11419963     DOI： 10.1006/phrs.2001.0820

Source DB:  PubMed          Journal:  Pharmacol Res        ISSN： 1043-6618            Impact factor:   7.658


  3 in total

1.  When is a metric not a metric? Remarks on direct curve comparison in bioequivalence studies.

Authors:  Wojciech Jawień
Journal:  J Pharmacokinet Pharmacodyn       Date:  2009-06-21       Impact factor: 2.745

2.  Bioequivalence tests based on individual estimates using non-compartmental or model-based analyses: evaluation of estimates of sample means and type I error for different designs.

Authors:  Anne Dubois; Sandro Gsteiger; Etienne Pigeolet; France Mentré
Journal:  Pharm Res       Date:  2009-10-30       Impact factor: 4.200

3.  Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies.

Authors:  Joannes A A Reijers; T van Donge; F M L Schepers; J Burggraaf; J Stevens
Journal:  Eur J Clin Pharmacol       Date:  2016-08-11       Impact factor: 2.953
  3 in total

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