Bioequivalence and Bioavailability Forum • Change in study design and required approval

Change in study design and required approval [Regulatives / Guidelines]

posted by Naveen Kumar – India, 2013-07-11 11:50 (4732 d 15:44 ago) – Posting: # 10971
Views: 4,104

Dear docksr,

Please follow the link http://cdsco.nic.in/prescreening_new_drug_applications.pdf (section 4. Checklist for Protocol Amendment), changes in study design and sample size are considered as major protocol amendments and the checklist for submission was also provided.

you may have the chance to justify that the drug exposure on the subjects was decreased (i.e. instead of three doses, you are exposing for only two).

Regards,
Naveen Kumar SR

Complete thread:

Change in study design and required approval docksr 2013-07-10 11:13
- Change in study design and required approval Dr sridevi 2013-07-10 12:28
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