Bioequivalence and Bioavailability Forum

tarak_desai 2012-06-05 07:06 Posting: # 8659	retention samples for WHO submission study [Regulatives / Guidelines] Post reply
	Dear all, is there any retention requirement of IMP for WHO submission study? regards, TARAK

Helmut

Vienna, Austria,
2012-06-06 00:15

@ tarak_desai
Posting: # 8667

retention samples for WHO submission study

Post reply

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.

—

All the best, Helmut Schütz.

Profile «accessible to registered users only»
The quality of responses received is directly proportional to the quality of the question asked. ☼
→ Science Quotes

retention samples for WHO submission study [Regulatives / Guidelines]

retention samples for WHO submission study