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. The Expert Committee agreed to prepare this working document, which has been drafted by Dr.
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 Dissolution, Dissolution, Method Validation in Pharmaceutical Analysis, Drug Product, Drug, Development and validation of dissolution method, And Quality by Design exemplified, Product, For drug, Dissolution Method Development for Immediate Release, ANALYTICAL METHOD, CHROMATOGRAPHIC METHOD FOR THE ESTIMATION, Guidelines on good manufacturing practices, TPI 2015; 4(5): 14-20