Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-03-31 02:30 CEST (UTC+2h)
 
tarak_desai
Junior

India,
2012-06-05 07:06

Posting: # 8659
Views: 1,159
 

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

@ tarak_desai
Posting: # 8667
Views: 930
 

 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.


[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
16,723 Posts in 3,587 Threads, 1,040 registered users;
9 users online (0 registered, 9 guests).

A big computer, a complex algorithm and a long time
does not equal science.    Robert Gentleman

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed