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

posted by Achievwin – US, 2023-05-05 18:08 (350 d 18:26 ago) – Posting: # 23546
Views: 1,353

Hello Mithu:

505 (b)(2) is all about the submission and marketing strategy. Most of the 505(b)(2) applications take BE route as drug Chemistry, safety and efficacy along with biopharmaceutics is already known and BE is used as a knowledge (claim) gap bridging approach. There are other means you can get 505(b)(2. Please review different guidance (FDA, EMA etc.) or white papers on 505(b)(2).

Hope this helps

Complete thread:

UA Flag
 Admin contact
22,988 posts in 4,825 threads, 1,657 registered users;
79 visitors (0 registered, 79 guests [including 3 identified bots]).
Forum time: 12:34 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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