SMA
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Europe,
2024-01-16 10:51
(47 d 15:29 ago)

(edited by SMA on 2024-01-16 11:07)
Posting: # 23828
Views: 617
 

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

Dear all

EMA has published two new PSGs:
  • Azacitidine powder for suspension for injection 25 mg/ml product-specific bioequivalence guidance (here)
  • Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance (here)
Consultations open until 2024-04-30
dshah
★★  

India/United Kingdom,
2024-01-17 11:12
(46 d 15:08 ago)

@ SMA
Posting: # 23830
Views: 487
 

 New EMA product specific guidance (PSG)

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%?

Regards,
Divyen
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