debabrata
●    

2005-10-19 08:58
(6735 d 07:48 ago)

Posting: # 42
Views: 21,480
 

 Investigational Products for BA/BE [Regulatives / Guidelines]

According to Canadian Regulatory requirement, what is the retention sample quantity that has to be kept in the CRO after completion of the study? Also what is the retention period?
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2005-10-19 13:22
(6735 d 03:24 ago)

@ debabrata
Posting: # 43
Views: 20,116
 

 Investigational Products for BA/BE

Hi!

'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states:

Retention of Samples
It is recommended that samples of the test and reference drug products used in the comparative bioavailability study(ies), and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.

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
debabrata
●    

2005-10-20 09:22
(6734 d 07:24 ago)

@ debabrata
Posting: # 44
Views: 16,515
 

 Investigational Products for BA/BE

❝ According to Canadian Regulatory requirement, what is the retention sample quantity that has to be kept in the CRO after completion of the study? Also what is the retention period?


Is there any specific retention quantity that has to be kept in the CRO like US FDA?
H_Rotter
★    

Germany,
2005-10-20 17:43
(6733 d 23:03 ago)

@ debabrata
Posting: # 45
Views: 16,312
 

 Investigational Products for BA/BE

I don't think so; have you considered asking HPFB?

Regards,
Hermann
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
72 visitors (0 registered, 72 guests [including 6 identified bots]).
Forum time: 15:46 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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