Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report
Journal Title: The AAPS Journal - Year 2010, Vol 12, Issue 3
Abstract
Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current industry practices and regulatory expectations for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.
Authors and Affiliations
Mei-Ling Chen, Vinod P. Shah, Derek Ganes, Kamal K. Midha, James Caro, Prabu Nambiar, Mario L. Rocci, Jr. , Avinash G. Thombre, Bertil Abrahamsson, Dale Conner, Barbara Davit, Paul Fackler, Colm Farrell, Suneel Gupta, Russell Katz, Mehul Mehta, Sheldon H. Preskorn, Gerard Sanderink, Salomon Stavchansky, Robert Temple, Yaning Wang, Helen Winkle, Lawrence Yu
Keywords
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