Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Consider 505(b)(2) Pathway [Design Issues]

posted by bebac_fan – US, 2018-05-05 19:08 (2968 d 23:09 ago) – Posting: # 18756
Views: 4,422

I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA.

In this case, comparative efficacy, rather than BE, will be considered pivotal.

Complete thread:

Bioequivalence of IR vs MR tablet heritage 2018-05-05 06:25
- Consider 505(b)(2) Pathwaybebac_fan 2018-05-05 17:08
  - Pathway for Softgel vs Tablet Comparison Obinoscopy 2018-05-15 19:04
    - Pathway for Softgel vs Tablet Comparison jag009 2018-05-18 16:33

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
142 visitors (0 registered, 142 guests [including 28 identified bots]).
Forum time: 18:18 CEST (Europe/Vienna)

Science is simply common sense at its best that is,
rigidly accurate in observation, and
merciless to fallacy in logic. Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz