Posting: # 8659
retention samples for WHO submission study [Regulatives / Guidelines]
is there any retention requirement of IMP for WHO submission study?
Posting: # 8667
retention samples for WHO submission study
» is there any retention requirement of IMP for WHO submission study?
Up to you.
WHO Technical Report Series, No. 937, Annex 9: Additional guidance for organizations performing in vivo bioequivalence studies (2006)
5.4. Product samples should be retained for a specified period in compliance with local requirements or international recommendations as appropriate and should be defined in the SOP.
All the best, Helmut Schütz.
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