FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-05-24 03:26 (885 d 12:02 ago) – Posting: # 18810
Views: 2,231

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

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