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Bioequivalence assessment: a pharmaceutical industry perspective.

Godbillon, J and Cardot, J M and Lecaillon, J B and Lefevre, Gilbert and Sioufi, A (1996) Bioequivalence assessment: a pharmaceutical industry perspective. European journal of drug metabolism and pharmacokinetics, 21 (2). pp. 153-158. ISSN 0378-7966

Abstract

Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequivalence studies conducted either during the development of the drug or after its marketing will be presented and discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for the final market image. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.

Item Type: Article
Date Deposited: 28 Jan 2012 00:45
Last Modified: 01 Feb 2013 00:46
URI: https://oak.novartis.com/id/eprint/5284

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