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Back to the forum  2018-06-22 19:11 CEST (UTC+2h)
tarak_desai
Junior

India,
2012-06-05 07:06

Posting: # 8659
Views: 1,204
 

 retention samples for WHO submission study [Regulatives / Guidelines]

Dear all,

is there any retention requirement of IMP for WHO submission study?

regards,
TARAK
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2012-06-06 00:15

@ tarak_desai
Posting: # 8667
Views: 971
 

 retention samples for WHO submission study

Dear Tarak!

» 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.


Cheers,
Helmut Schütz
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