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. In vivo equivalence studies in humans General considerations Provisions for studies in humans Justification of human bioequivalence studies Selection of investigators Study protocol 1437.
7. Pharmacokinetic comparative bioavailability (bioequivalence) studies in humans 144 7.1 Design of pharmacokinetic studies 144 7.1.1 Alternative study designs for studies in patients 145 7.1.2 Considerations for active pharmaceutical ingredients with long elimination half-lives 145 7.1.3 Considerations for multiple-dose studies 145
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