精选优质文档-倾情为你奉上 Guidance for Industry 行业指南ANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA:原料药和制剂稳定性试验问答Final GUIDANCE最终稿指南U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2014GenericsGuidance for IndustryANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA:原料药和制剂稳定性试验问答Additional copies are available from:Office of