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

posted by Pharma_88 – India, 2020-03-13 09:37 (1696 d 19:55 ago) – Posting: # 21261
Views: 4,259

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.

Regards,
Pharma_88

Complete thread:

UA Flag
Activity
 Admin contact
23,280 posts in 4,889 threads, 1,655 registered users;
45 visitors (0 registered, 45 guests [including 9 identified bots]).
Forum time: 05:32 CET (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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