US (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]

posted by jag009  – NJ, 2022-09-02 00:16 (152 d 08:39 ago) – Posting: # 23258
Views: 2,070

Hi all,

A question, has anyone ever filed an ANDA with great BE study results (90% Cmax and AUC ~ 98-100%, adequate sample size, ISCV~25%) but with f2 << 50 (F2=30 due to differences in very early timepts) in the comparative dissolution study based on method recommended in the BE guidance for IR product?

1) F2 is not really applicable for IR, correct? The sampling timepts were 5, 10 ,20, 30, 45mins. I know that f2 is not really relevant if % dissolve > 85% in 15 mins, but my product is >85% after 20 mins..
2) is f2 based on guidance recommendation even relevant if the BE results are so good?

Thx
john

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