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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Product Lifecycle Management for the Pharmaceutical, Development, Pharmaceutical, Oracle Pharmaceutical, ICH Q10 Pharmaceutical Quality System, Pharmaceutical Development, Valuation Analysis in Pharmaceutical Licensing, DEVELOPMENT OF PAEDIATRIC MEDICINES: POINTS, Development of paediatric medicines: points to consider in pharmaceutical development, Stability Testing of Pharmaceutical Products