debabrata
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2005-10-19 06:58

Posting: # 42
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 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
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Vienna, Austria,
2005-10-19 11:22

@ debabrata
Posting: # 43
Views: 16,741
 

 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'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states: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and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.

Cheers,
Helmut Schütz
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debabrata
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2005-10-20 07:22

@ debabrata
Posting: # 44
Views: 13,277
 

 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
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Germany,
2005-10-20 15:43

@ debabrata
Posting: # 45
Views: 13,093
 

 Investigational Products for BA/BE

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

Regards,
Hermann
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