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.
5.1 In vivo studies 142 5.2 In vitro studies 142 6. In vivo equivalence studies in humans 142 6.1 General considerations 142 6.1.1 Provisions for studies in humans 142 6.1.2 Justification of human bioequivalence studies 143 6.1.3 Selection of investigators 143 6.1.4 Study protocol 143 7. Pharmacokinetic comparative bioavailability (bioequivalence)
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