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RegisterFDA: Biowaiver on lower strengths [Regulatives / Guidelines]
Hi guys and girls,
Question. When one does the f2 comparisons for a biowaiver on lower strengths, they are usually strength 1 vs RLD strength 2, strength 2 vs RLD strength 2, etc etc. If one passes these comparison but fails f2 for some of the lower strength vs highest strength comparison of the test products themselves, would that be an issue?
Thanks
John
Question. When one does the f2 comparisons for a biowaiver on lower strengths, they are usually strength 1 vs RLD strength 2, strength 2 vs RLD strength 2, etc etc. If one passes these comparison but fails f2 for some of the lower strength vs highest strength comparison of the test products themselves, would that be an issue?
Thanks
John
Complete thread:
- FDA: Biowaiver on lower strengthsjag009 2018-05-24 03:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: Biowaiver on lower strengths wienui 2018-05-24 15:25
- FDA: Biowaiver on lower strengths Yura 2018-05-25 10:22
- FDA: Biowaiver on lower strengths Yura 2018-05-26 17:21
Ing. Helmut Schütz