Bioequivalence and Bioavailability Forum

AAPS Workshop on Role of Dissolution in QbD and Drug Product Life Cycle
April 28 - 30, 2008
Hyatt Regency
Crystal City, VA
Co-Sponsored by: The U.S. Food and Drug Administration

Background

Dissolution is an integral test utilized in establishing the quality of solid dosage forms. For some drugs, dissolution can serve as a test of both pharmaceutical as well as biopharmaceutical quality of the product. But for most drug products, dissolution serves as a test of pharmaceutical quality only, (i.e., a QC test). The dissolution specifications should be set keeping the objective in mind. In the context of PAT and QbD, dissolution may serve a more important role in some cases, while in others, if other critical parameters are more relevant, dissolution may not be needed as a test. This workshop is aimed at exploring the dissolution test as a viable tool in the Quality by Design environment in the 21^st century.

Goals and Objectives

During this workshop, we will discuss
> the impact of Quality by Design (QbD) as it applies to dissolution testing;
> why dissolution testing methods and specifications should be clinically relevant (IVIVC/IVIVR);
> the relevance of dissolution through various stages of product development;
> other tests that may complement the dissolution test;
> the role of dissolution in assessing drug release from novel and extended release dosage forms; and
> the recent advances in dissolution technology.

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