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• In Vitro Release Testing of Dosage Forms Based on Novel Technologies: Developments and Challenges

Monday, November 12

2:00 pm – 4:30 pm

Symposium

ACPE #073-999-07-514-L04

Rapid advances in formulation and design of dosage forms using novel technologies have highlighted a need for in vitro release test methods as an indicator of product performance. Since there are no regulatory standards available for these dosage forms, e.g., sustained release parenteral delivery systems or drug-device combination products, a variety of in vitro release tests have been reported in literature. Although these in vitro release tests have been used as an indicator of in vivo performance, the basis of selection for an in vitro release method is in having a good IVIVC (In vitro-In vivo Correlation). Therefore, it is necessary that the in vitro method employed must simulate the in vivo condition and the release mechanism as accurately as possible. This would provide a greater understanding of mechanisms that govern release and possibly enable setting of more meaningful specifications from a regulatory perspective. Therefore, the objectives of this symposium are to highlight new strategies used to evaluate drug release from dosage forms designed using novel technologies and their potential use in product development.

ModeratorS

Susan S. D'Souza, Ph.D.
Schering Plough Research Institute

Sunil S. Iyer, Ph.D.
Virginia Commonwealth University

A New ‘Biorelevant’ Approach to Accelerated Release Testing and IVIVC of a Long-acting Biodegradable Implant
Sunil S. Iyer, Ph.D.
Virginia Commonwealth University

Accelerated Methods to Characterize In Vitro Drug Release from Biodegradable Microspheres
Susan S. D'Souza, Ph.D.
Schering Plough Research Institute

Combinatorial Design of Biomaterials and Drug Delivery: Challenges and Opportunities
Balaji Narasimhan, Ph.D.
Iowa State University

Drug Eluting Stents: Characterization of Release Kinetics
Micheline Markey, Ph.D.
Conor Medsystems

Dissolution of Low Solubility Products: Case Studies
Pradeep Sathe, Ph.D.
U.S. Food and Drug Administration

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