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

posted by ping4santosh  – India, 2020-03-13 10:01 (927 d 12:47 ago) – Posting: # 21263
Views: 1,720

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
22,390 posts in 4,685 threads, 1,594 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Monday 23:49 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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