In vitro-in vivo relationships for oral extended-release drug products

J Biopharm Stat. 1997 Nov;7(4):565-78. doi: 10.1080/10543409708835207.

Abstract

It is of interest to predict the in vivo behavior of an oral extended-release drug product based on its in vitro dissolution profile. In some cases a suitable convolution-based prediction model can be found. We present a methodology for developing statistical models of in vitro-in vivo relationships under the framework of the mixed-effects nonlinear model and discuss methods for assessing the validity and strength of the relationship. These methods are illustrated and contrasted with a level A in vitro-in vivo correlation using data from a study involving four different formulations of an oral extended-release drug product.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Delayed-Action Preparations*
  • Humans
  • In Vitro Techniques
  • Mathematical Computing
  • Models, Biological*
  • Models, Statistical*
  • Pharmacokinetics*
  • Predictive Value of Tests

Substances

  • Delayed-Action Preparations