Bioequivalence and Bioavailability Forum

Yes we need to apply for fresh approval with DCGI

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Edit: Please follow the Forum’s Policy. [Helmut]

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

Dear Docksr;

Amendment in the basic study design should be notified to DCGI and approval is required before teh study initiation.

And there is another clause;
if you have three way with two sequence (T1RT2 & RT1T2); you can initiate the study and terminate the last period (T2). reason for terminating the last period should be stated in report, and the section change in conduct of the study to be updated with a deviation filled.

Regards

K@K

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]