bkrao
☆    

India,
2015-08-17 15:45
(3608 d 15:24 ago)

Posting: # 15281
Views: 3,391
 

 Criteria for Highly variable drugs in Canada Regulatory [Regulatives / Guidelines]

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Is there any special criteria in the Canada regulatory for highly variable drug products (HVD)? I hope, Canada source guidelines in the 2012 doesn't comprises any special criteria with respect to the HVD.

Thanks in advance.
B.K.Rao.
 
Mahesh M
★    

India,
2015-08-17 16:51
(3608 d 14:18 ago)

@ bkrao
Posting: # 15282
Views: 2,704
 

 Criteria for Highly variable drugs in Canada Regulatory

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Please find below link

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/index-eng.php

Regards
 
bkrao
☆    

India,
2015-08-18 08:21
(3607 d 22:48 ago)

@ Mahesh M
Posting: # 15291
Views: 2,728
 

 Criteria for Highly variable drugs in Canada Regulatory

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Thanks you Mahesh.
Now i came to know that the criteria for the HVD in Canada is widening and that to only applicable for the AUC but not to the Cmax.

I hope that i am too slow in regulatory updates.

Thanks to you and satyam thota gaaru also.

Regards,
B. K. Rao.
 
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