Abstract #300698

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JSM 2003 Abstract #300698
Activity Number: 296
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300698
Title: A New Approach for Evaluating IVIVC that does not Require Common Measurement Times for Dissolution and Absorption
Author(s): A. Lawrence Gould*+ and Lisa Lynn Hickey and James T. Kost and Nancy G. Agrawal and Thanh V. Goel and Shaun Fitzpatrick
Companies: Merck Research Laboratories and Merck & Company and University of Rochester and Merck Research Laboratories and Merck Research Laboratories and Merck Research Laboratories
Address: BL3-2, West Point, PA, 19486,
Keywords: prediction ; bioavailability ; pharmacokinetic ; in vitro-in vivo correlation
Abstract:

In Vitro-In Vivo Correlation methods support approving a change in formulation of a drug using only dissolution data without additional bioequivalence trials in human subjects. IVIVC assumes that the absorption of a drug depends only on the time course of its presentation, e.g., in the gastric lumen, and not on how it actually is delivered. Current IVIVC methods relate the (cumulative) percentage of administered dose absorbed by the body to the cumulative dissolution of a dosage unit under controlled conditions, with both percentages measured at common time points. We describe, and illustrate with data on a controlled-release formulation, an approach to evaluating IVIVC that does not require absorption and dissolution measurements at common times. We express the plasma concentration curve in terms of dissolution percentage instead of time, using the dissolution curve to provide a noisy correspondence between these quantities. All conventional functionals of the concentration curve such as AUC, Cmax, and Tmax can be expressed in terms of dissolution percentage, with uncertainties arising from variability in measuring absorption and dissolution accounted for explicitly.

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