Pathway for Softgel vs Tablet Comparison [Design Issues]

posted by Obinoscopy  – USA, 2018-05-15 19:04 (897 d 20:10 ago) – Posting: # 18764
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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

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