药品研发指南(英文)资料精.pdfVIP

ORAL TABLETS DEVELOPMENTDEVELOPMENT CHAPTER 2 PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETSTABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. The order of performing the various stages may change depending on the product under development. These guidelines may be modified for other geographic zones. Development Stage Scope of Product Development Stage 1 Literature Search Literature Rese