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

posted by Pharma_88 – China, 2020-03-13 08:37  – Posting: # 21261
Views: 2,195

Hello All,

Greetings!!

We got an inquiry to conduct BE for XYZ molecule but at the time of feasibility we came to know that RLD for XYZ molecule is not approved/marketed in our country. Means there is no RLD.

Still sponsor wants to market their product. In this case, what we can do? Can we do directly PK study or Phase III study of sponsor's product in patients?

Thanks.

Complete thread:

Activity
 Admin contact
20,456 posts in 4,296 threads, 1,413 registered users;
online 14 (0 registered, 14 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 19:52 CEST

No one wants to learn from mistakes, but we cannot learn enough
from successes to go beyond the state of the art.    Henry Petroski

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