Helmut ★★★ Vienna, Austria, 2008-04-11 00:42 (5858 d 08:14 ago) Posting: # 1767 Views: 4,884 |
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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 21st 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. For some presentations please visit here. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |