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.

Policy and Standards (PSM), World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; e-mails: ... on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or ... Pharmaceutical product target profile (PPTP) forms the basis of design for the ...

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