tarak_desai
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India,
2012-06-05 09:06
(4339 d 23:01 ago)

Posting: # 8659
Views: 1,543
 

 retention samples for WHO submission study [Regulatives / Guidelines]

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Dear all,

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

regards,
TARAK
 
Helmut
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Vienna, Austria,
2012-06-06 02:15
(4339 d 05:51 ago)

@ tarak_desai
Posting: # 8667
Views: 1,259
 

 retention samples for WHO submission study

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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.

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