Posting: # 8659 Views: 992
is there any retention requirement of IMP for WHO submission study?
Posting: # 8667 Views: 819
» 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,
The quality of responses received is directly proportional to the quality of the question asked. ☼