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. 2010 Sep;12(3):371-7.
doi: 10.1208/s12248-010-9201-5. Epub 2010 May 4.

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report

Mei-Ling Chen  1 , 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
Affiliations

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report

Mei-Ling Chen et al. AAPS J. 2010 Sep.

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.

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References

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