Transcription of DRAFT PHARMACEUTICAL DEVELOPMENT FOR …
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DRAFT PHARMACEUTICAL DEVELOPMENT FOR …
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.
Fixed-dose combinations (FDCs) are rare among prescription drugs. FDCs occur frequently in the WHO List of Essential Medicines and they have special features for pharmaceutical development. The manufacturing process development is the same for innovator and generic pharmaceutical industries. 1.1 Objectives
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