govardhanpillari
☆    

India,
2007-11-22 08:15
(6795 d 01:39 ago)

Posting: # 1319
Views: 2,202
 

 Required Pharmacokinetic studies [Regulatives / Guidelines]

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Dear All
Please let me know the pharmacokinetic studies should equired for 505 (b) (2) NDA submission. Any waivers is there for pharmacokinetic studies.

Regards,
govardhan.P
—
Govardhan.P
 
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