505 b(2) application & requirement of bio­equi­va­lence [Regulatives / Guidelines]

posted by Mithu – India, 2023-05-04 06:59 (330 d 01:06 ago) – Posting: # 23541
Views: 1,497

Hello All,


My question is, "is it mandatory to have 505b(2) application bio-equivalent to current reference listed drug?"

regards,

Mithu

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
87 visitors (0 registered, 87 guests [including 7 identified bots]).
Forum time: 07:05 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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