Transcription of DRAFT PHARMACEUTICAL DEVELOPMENT FOR …
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Working document January 2008 RESTRICTED DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS This DRAFT is based on the concept paper QSM/ Guideline for PHARMACEUTICAL DEVELOPMENT for generics presented to the 42nd meeting of the WHO Expert Committee on Specifications for PHARMACEUTICAL Preparations, Geneva, 15-19 October 2007, and on the DRAFT report from that meeting.
Working document QAS/08.251 page 4 1. INTRODUCTION Differences between the innovator and multisource (generic) finished pharmaceutical products (FPPs) justify the need for a WHO guideline on pharmaceutical product
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