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RegisterPathway for Softgel vs Tablet Comparison [Design Issues]
Dear bebac_fan,
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,
❝ 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
Scopy
Complete thread:
- Bioequivalence of IR vs MR tablet heritage 2018-05-05 06:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Pathway for Softgel vs Tablet ComparisonObinoscopy 2018-05-15 19:04
- Consider 505(b)(2) Pathway bebac_fan 2018-05-05 17:08
Ing. Helmut Schütz