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RegisterPathway for Softgel vs Tablet Comparison [Design Issues]
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
» 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]
![[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 Comparison Obinoscopy 2018-05-15 19:04
- Pathway for Softgel vs Tablet Comparisonjag009 2018-05-18 16:33
- Pathway for Softgel vs Tablet Comparison Obinoscopy 2018-05-15 19:04
- Consider 505(b)(2) Pathway bebac_fan 2018-05-05 17:08
Ing. Helmut Schütz