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Back to the forum  2018-07-23 17:02 CEST (UTC+2h)

Pathway for Softgel vs Tablet Comparison [Design Issues]

posted by Obinoscopy - Nigeria, 2018-05-15 19:04  - Posting: # 18764
Views: 305

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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