New EMA product specific guidance (PSG) [BE/BA News]

posted by dshah  – India/United Kingdom, 2024-01-17 11:12 (124 d 18:39 ago) – Posting: # 23830
Views: 915

Thanks SMA for sharing.

Dear all, In Azacitidine powder for suspension for injection PSG, I am having a small question.

For biowaiver it is mentioned- "Equivalent particle size distribution as demonstrated by showing average equivalence for D10, D50, D90 and span within an acceptance range of 15% for the ratio of geometric means between test and reference products (i.e., 85.00–117.64%)."
But it also mentions: "At least 3 batches of the test and reference product should be included in the comparability studies. More batches may be needed in case of higher variability of the reference product results."

So in case of higher variability in reference product result for PSD, the ratio should be limited to 85.00–117.64%?


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