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 January 2008 RESTRICTED DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS This draft is based on the concept paper QSM/EC/07.29 “Guideline for pharmaceutical
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Analytical Method Selection for Drug Product, Analytical Method Selection for Drug Product Dissolution, Chapter-2 Analytical Method Development and, Analytical Method Development and Validation, Drug product, Q1A(R2) Guideline Stability Testing of New, Q1A(R2) Guideline Stability Testing of New Drug, ANALYTICAL METHOD, CHROMATOGRAPHIC METHOD FOR THE ESTIMATION, Fao animal production and health, DRUG SUBSTANCE: DEFINING REGULATORY, DRUG SUBSTANCE: DEFINING REGULATORY STARTING MATERIALS