Bioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-13 10:01 (883 d 03:22 ago) – Posting: # 21263
Views: 1,708

Hello,

If the RLD is unavailable in your country (yet to get register), how would the generic market itself? In EU and middle East, the RLD has to be registered in the target market for the generic to get a chance based on BE. It could be different in China.

What I understand from your draft is that you are the CRO. If sponsor gives you the RLD and test article you can go for pK based study.

Cheers, SKM

Complete thread:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 17 (0 registered, 17 guests [including 10 identified bots]).
Forum time: Saturday 14:24 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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