Transcription of Annex 7 - WHO
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Annex 7 - WHO
131 Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability11 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Products: fortieth report . World Health Organization: Geneva; 2006: Annex 7 (WHO Technical report Series, No. 937).1. Introduction 1342. Glossary 1353. Documentation of equivalence for marketing authorization 1394. When equivalence studies are not necessary 1405. When equivalence studies are necessary and types of study required In vivo studies In vitro studies 1426.
132 WHO Technical Report Series No. 992, 2015 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-ninth report 7.3 Investigational product 150 7.3.1 Multisource pharmaceutical product 150 7.3.2 Choice of comparator product 150 7.4 Study conduct 151 7.4.1 Selection of strength 151 7.4.1.1 Non-linear pharmacokinetics 151 7.4.2 Study standardization …
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