DCGI-Stability Data [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-08-17 20:27 (3463 d 23:33 ago) – Posting: # 15289
Views: 2,659

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 :confused: 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...

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,662 registered users;
236 visitors (0 registered, 236 guests [including 6 identified bots]).
Forum time: 19:00 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5