tarak_desai ☆ India, 2012-06-05 09:06 (4341 d 04:34 ago) Posting: # 8659 Views: 1,546 |
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Dear all, is there any retention requirement of IMP for WHO submission study? regards, TARAK |
Helmut ★★★ Vienna, Austria, 2012-06-06 02:15 (4340 d 11:24 ago) @ tarak_desai Posting: # 8667 Views: 1,260 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |