Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation

摘要

This guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change (1) the components or composition, (2) the site of manufacture, (3) the scale-up/scale-down of manufacture, and/or (4) the manufacturing (process and equipment) of a modified release solid oral dosage form during the post approval period. The guidance defines (1) levels of change, (2) recommended chemistry, manufacturing, and controls (CMC) tests for each level of change, (3) recommended in vitro dissolution tests and/or in vivo bioequivalence tests for each level of change; and (4) documentation that should support the change. This guidance specifies application information that should be provided to the Center for Drug Evaluation and Research (CDER) to ensure continuing product quality and performance characteristics of a modified release solid oral dose formulation for specified post approval changes.