In vitro/in vivo correlations can and should be developed in many cases. This paper provides one approach to developing in vitro/in vivo correlations, along with examples, based upon the position of the United States Pharmacopeia (USP) Subcommittee on Bioavailability, Bioequivalence, and Dissolution (DBA). Although correlations should not be required, the Food and Drug Administration (FDA) must take a definitive position on the issue, accepting approaches which truly reflect in vivo performance.
LooJCKRiegelmanS.New Method for Calculating the Intrinsic Absorption Rate of Drugs. J Pharma Sci.1968;57:984–989.
5.
LangenbucherF.Numerical Convolution/De-convolution as a Tool for Correlating In Vitro with In Vivo Availability. Die Pharmazeutische Industrie.1982;44(11):1166–1172.
6.
SteinijansVW. Pharmacokinetic Characterization of Controlled-Release Formulations. European J Drug Metab Pharmacokin.1990;15(2):173–181.
