bkrao
☆    

India,
2015-08-17 15:45
(3965 d 22:01 ago)

Posting: # 15281
Views: 4,024
 

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

Post reply
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
(3965 d 20:55 ago)

@ bkrao
Posting: # 15282
Views: 3,191
 

 Criteria for Highly variable drugs in Canada Regulatory

Post reply
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
(3965 d 05:26 ago)

@ Mahesh M
Posting: # 15291
Views: 3,261
 

 Criteria for Highly variable drugs in Canada Regulatory

Post reply
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.
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
386 visitors (0 registered, 386 guests [including 25 identified bots]).
Forum time: 13:47 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

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