bkrao ☆ India, 2015-08-17 15:45 (3173 d 16:18 ago) Posting: # 15281 Views: 2,729 |
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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 (3173 d 15:12 ago) @ bkrao Posting: # 15282 Views: 2,190 |
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bkrao ☆ India, 2015-08-18 08:21 (3172 d 23:43 ago) @ Mahesh M Posting: # 15291 Views: 2,208 |
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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. |