retention samples for WHO submission study [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-06-06 02:15 (4334 d 15:28 ago) – Posting: # 8667
Views: 1,244

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! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,986 posts in 4,823 threads, 1,668 registered users;
63 visitors (0 registered, 63 guests [including 4 identified bots]).
Forum time: 17:44 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5