WHO Guidance for organizations performing in vivo bioequivalence studies - Annex 9
Background
During an informal consultation held in 2014, and at the forty-ninth meeting of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations, discussion took place regarding the possible revision of the guidance for organizations performing in vivo bioequivalence studies (WHO Technical Report Series, No. 937, Annex 9, 2006). The WHO Expert Committee on Specifications for Pharmaceutical Preparations agreed that in light of the new developments a draft for revision would be prepared.
These new guidelines take into consideration the revision of the multisource guidelines, as well as the creation of new guidance on good data management. The revision will also take into account the experience accumulated in the area of assessing and inspecting bioequivalence (BE) studies since 2006. In areas where the same problems are repeatedly identified by inspectors, the new guidelines provide clarifications, and supplementary details have been added on bioanalysis. The guidelines also put increased emphasis on subject safety and data integrity.
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TABLE OF CONTENTS
3. Organization and management
11.1 Independent ethics committee
14. Receiving, storage and handling of investigational products
16. Volunteers and recruitment methods
18. Safety, adverse events and adverse event reporting
21. Sample collection, storage and handling of biological material
23. Data processing and documentation
D. PHARMACOKINETIC, STATISTICAL CALCULATIONS AND
25. Pharmacokinetic and statistical calculations
Appendix 1 Example list of standard operating procedures at a contract research organization
WHO TRS (Technical Report Series) 966, 2016 Annex 9
