Bioequivalence and Bioavailability Forum • Pathway for Softgel vs Tablet Comparison

Pathway for Softgel vs Tablet Comparison [Design Issues]

posted by Obinoscopy – USA, 2018-05-15 21:04 (2556 d 11:27 ago) – Posting: # 18764
Views: 3,223

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:

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