Bioequivalence and Bioavailability Forum

Dear All,

As per "GUIDELINES FOR REQUIREMENT OF CHEMICAL AND PHARMACEUTICAL INFORMATION INCLUDING STABILITY STUDY DATA BEFORE APPROVAL OF CLINICAL STUDIES/ BE STUDIES, EFFECTIVE DATE: 21.12.2011," Which states that For BA/BE studies applicant need to submit minimum one month accelerated as well real time stability study data in respect of trial batches to be used in the trial with commitment that stability data will be provided at required intervals as and when data becomes available.

After receipt of BENOC from CDSCO office,BENOC mentioned that "Stability data sufficient to cover storage, shipment, and uses of the investigational product should be submitted before initiation of the study.

If we got this clause on BENOC then we need to submit the stability data as per clause mentioned on the BENOC, before initiation of the study.

My question is when we got this clause on BENOC exact how much month stability data we need to submit the DCGI or we need to submit the data of three months.As per previous experience with DCGI is that even after submission of three month stability data we received the above clause on BENOC.


Regards
Bharat N.