Pathway for Softgel vs Tablet Comparison [Design Issues]

posted by Obinoscopy  – USA, 2018-05-15 21:04 (2465 d 10:36 ago) – Posting: # 18764
Views: 3,080

Dear bebac_fan,

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



I share the same view with you on this.

However I have a case where a BE study was conducted comparing Metronidazole tablet (Reference) with Metronidazole soft gel (test). Both were IR. Is this acceptable?

Regards,

Scopy

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,661 registered users;
31 visitors (0 registered, 31 guests [including 4 identified bots]).
Forum time: 06:41 CET (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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