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DOI: 10.1208/s12248-012-9359-0Pages: 491-499

In vitro–In Vivo Correlations: Tricks and Traps

1. Auvergne University, UFR Pharmacie, ERT-CIDAM, Biopharmaceutical Department

2. Center for Drug Evaluation and Research, US Food and Drug Administration, Division of Bioequivalence II, Office of Generic Drugs

Correspondence to:
J.-M. Cardot
Tel: +33-4-73177968
Fax: +33-4-73177959
Email: j-michel.cardot@u-clermont1.fr

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Abstract

In vitro–in vivo correlation (IVIVC) is a biopharmaceutical tool recommended to be used in development of formulation. When validated, it can speed up development of formulation, be used to fix dissolution limits and also as surrogate of in vivo study. However, as do all tools, it presents limitations and traps. The aim of the present paper is to investigate five common traps which could limit either the setting or use of IVIVC (1) using mean or individual values; (2) correction of absolute bioavailability; (3) correction of lag time and time scaling; (4) flip-flop model; and (5) predictability corrections.

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  • Accepted: Apr 5, 2012
  • Online: May 1, 2012

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