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Review
. 1993 Jan-Mar;18(1):121-9.
doi: 10.1007/BF03220015.

In vitro/in vivo correlations in biopharmaceutics: scientific and regulatory implications

J P Skelly  1 , G F Shiu
Affiliations
Review

In vitro/in vivo correlations in biopharmaceutics: scientific and regulatory implications

J P Skelly et al. Eur J Drug Metab Pharmacokinet. 1993 Jan-Mar.

Abstract

This paper explains the regulatory and scientific reasons for the regulatory authorities employing dissolution as a key variable for regulatory approval of batch to batch bioequivalence assurance, site of manufacture change, formulation changes, and batch size scale-up for immediate release dosage forms. It also explains the scientific and regulatory reasons why either an in vivo/in vitro correlation using USP's Level 'A', 'B' or 'C', or a newly proposed 'mapping' approach will be required for allowing such changes for controlled-release dosage forms.

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