pravin17
★    

India,
2014-07-23 14:38
(4346 d 17:18 ago)

Posting: # 13299
Views: 3,120
 

 Archival period of investigational product retention for HC [Regulatives / Guidelines]

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Dear All,

Please tell me the archival period of investigational product retention of bioequivalence studies for Health Canada.

Thank you
Pravin
 
kvgreddy06
☆    

India,
2014-07-23 19:53
(4346 d 12:03 ago)

@ pravin17
Posting: # 13301
Views: 2,452
 

 Archival period of investigational product retention for HC

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Dear All,

HC: 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and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.

Thank you
venu
 
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