Amalia
☆    

Greece,
2018-09-24 14:22
(1166 d 05:02 ago)

Posting: # 19299
Views: 1,123
 

 Pivotal study documentation for submission [Regulatives / Guidelines]

Dear all,

as this is my first post I will try to be as elaborate as possible.
Is it possible to send for a pivotal study, not from the validation batches, but from a 100,000 tabs batch prepared in the R&D lab (with GMP accreditation)?
If yes, I guess that it is vital for the specifications of your batch to be the same as the ones from the validation batches (which have not been concluded yet).
What documentation is required in order to link the biobatch with the validation batches?

Thank you in advance,

Amalia
Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).
Forum time: Friday 18:25 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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