| Literature DB >> 20347972 |
Mei-Ling Chen1, Vinod P Shah, Derek Ganes, Kamal K Midha, James Caro, Prabu Nambiar, Mario L Rocci, 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.
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 regulatory expectations and industry practices for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.Entities:
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Year: 2010 PMID： 20347972 DOI： 10.1016/j.ejps.2010.03.017
Source DB: PubMed Journal: Eur J Pharm Sci ISSN： 0928-0987 Impact factor: 4.384