Bioequivalence and Bioavailability Forum 09:18 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Test License [Regulatives / Guidelines]

posted by rajasekharkakarla - India, 2018-10-06 08:05  - Posting: # 19411
Views: 559

Dear All,

I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts:

1) Can I use remaining quantity of reference drug for pivotal

2) If we use remaining IPs, Is we need to get Test license permission for pivotal.

or

Is we need to apply fresh Test license to import Reference drug separately for pivotal.

Please guide me to overcome this issue.

Regards,
RK

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,929 posts in 4,039 threads, 1,286 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed