DRAFT PHARMACEUTICAL DEVELOPMENT FOR …

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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GUIDELINE ON SUBMISSION OF …

Working document QAS/10.373/Rev.1 page 6 173 174 1.5 Guidance on format 175 176 The recommendations outlined in the WHO general filing guideline Guideline on submission 177 of documentation for a multisource (generic) finished pharmaceutical product (FPP): 178 preparation of product dossiers (PDs) in common technical …

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FDA/PQRI Conference on Advancing Product Quality

Biopharmaceutics Classification System • BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal

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Excipients and information for the package leaflet EN

9 October 2017 EMA/CHMP/302620/2017 Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)

Medicines Control Council : General Information

Registration of Medicines General Information 2.01 General information Feb08 v4.doc April 2008 Page1 of 48 MEDICINES CONTROL COUNCIL GENERAL INFORMATION

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MEDICINES CONTROL COUNCIL - mccza.com

Registration of Medicines Pharmaceutical & Analytical 2.02 PA Jun11 v6 showing changes.doc Page June 2011 1 of 27 MEDICINES CONTROL COUNCIL PHARMACEUTICAL AND ANALYTICAL

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GUIDELINE ON SUBMISSION OF …

Working document QAS/10.375 page 5 116 an existing API is one that has been previously authorized through a finished product by a 117 stringent regulatory authority1.APIs from fermentation, biological, biotechnological or

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