Transcription of Annex 9 - WHO
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Annex 9 - WHO
439 World Health OrganizationWHO Technical Report Series, No. 937, 2006 Annex 9 Additional guidance for organizations performing in vivo bioequivalence studiesIntroduction1. Scope2. Glossary 3. Organization and management 4. Computer systems Hardware Software Data management 5. Archive facilities 6. Premises 7. Clinical phase 8. Clinical laboratory 9. Personnel 10. Quality assurance 11. Ethics Independent ethics committee Informed consent 12. Monitoring 13. Investigators 14. Receiving, storage and handling of investigational drug products15. Case-report forms 16. Volunteers recruitment methods 17. Dietary considerations 18. Safety, adverse events and reporting of adverse events 19. Sample collection, storage and handling of biological material20.
442 bioequivalence test A test that determines the equivalence between the multisource product and the comparator product using in vivo and/or in vitro approaches.
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