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Pathway for Softgel vs Tablet Comparison [Design Issues]

posted by jag009 – NJ, 2018-05-18 18:33 (2168 d 18:54 ago) – Posting: # 18786
Views: 2,483

Hi,

❝ 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?

Have you read this guidance? FDA

John

Complete thread:

Bioequivalence of IR vs MR tablet heritage 2018-05-05 06:25 [Design Issues]
- Consider 505(b)(2) Pathway bebac_fan 2018-05-05 17:08
  - Pathway for Softgel vs Tablet Comparison Obinoscopy 2018-05-15 19:04
    - Pathway for Softgel vs Tablet Comparisonjag009 2018-05-18 16:33

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