1. Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
- Author
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Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, and Yu L
- Subjects
- Bupropion pharmacokinetics, Bupropion pharmacology, Chemistry, Pharmaceutical, Drug Approval, Methylphenidate pharmacokinetics, Methylphenidate pharmacology, Pyridines pharmacokinetics, Pyridines pharmacology, Therapeutic Equivalency, United States, United States Food and Drug Administration, Zolpidem, Delayed-Action Preparations pharmacokinetics, Delayed-Action Preparations pharmacology, Drug and Narcotic Control legislation & jurisprudence
- 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.
- Published
- 2010
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