Bioequivalence and Bioavailability Forum

Dear Bharat,

❝ 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.

❝ 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.

Well, how could the CDSCO/DCGI know how long it will take between the production of your batch and its use in your trial ? Only you can say whether 3 months will be enough or not...