[2]ORALDRUGPRODUCTS—PRODUCTQUALITYTESTS#40;口服药物质量要求）USP39.pdf

Accessed from by ebsc0sa on Mon May 23 04:55:45 EDT 2016 76 á1ñ Injections / General Requirements USP 39 — Copolymer Ratio2 — Glass Transition Point2 — Coating Adhesion to Stent Surface2 — Tissue Reaction Tests2 — Polymer Molecular Weight2 PRODUCT PERFORMANCE TEST A performance test for injection and implanted products must have the ability to measure drug release from the manufac- tured pharmaceutical dosage forms. It must be reproducible and reliable, and although it is not a measure of bioavailability, the performance test must be capable of detecting changes in drug release characteristics from the finished product. These changes have the potential to alter the biological performance of the drug in the dosage form. They may be related to active or inactive/inert ingredients in the formulation, physical or chemical attributes of the finished formulation, manufacturing vari- ables, shipping and storage effects, aging effects, and other formulation factors critical to the quality characteristics of the fin- ished drug product. Please refer to The Dissolution Procedure: Development and Validation á1092ñ while developing the drug release test, selecting the drug release medium, apparatus or procedure, and analytical method. Product performance tests can serve many useful purposes in product development and in post-approval drug product monitoring. They provide assurance of equivalent per- formance for products that have undergone post-approval raw material changes, relocation or change in manufacturing site, s and other changes as detailed in the FDA SUPAC Guidances for Industry (SUPAC-IR, SUPAC-MR, and SUPAC-SS; available at