hallenges and Opportunities In Establishing Scientific and Regulatory Standards for Determining Therapeutic Equivalence of Modifled-Release Products: Workshop Summary Report

摘要

Background: Modified-release (MR) products are complex dosage forms designed to release drug in a controlled manner to achieve the desired efficacy and safety profiles. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity.Objective: This paper is a summary report of the American Association of Pharmaceutical Scientists, International Pharmaceutical Federation, and Product Quality Research Institute workshop titled "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products," held October 1-2, 2009, in Baltimore, Maryland.