Bioequivalence and Bioavailability Forum

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – 2021-10-21 18:51 (1703 d 16:00 ago) – Posting: # 22651
Views: 5,799

Dear Ohlbe,

❝ You can very well write in your SOP acceptance criteria of 2/3 and 50% at each level of concentration. By the way, the ICH M10 draft guideline (step 2, public consultation now ended) has dropped the awkward 67% criterion and replaced it with 2/3. We'll see what is decided in the final guideline.

❝

Yes. Will update the SOP and then when ICH M10 will be finalized our SOP already in line with the guideline.

Regards,
Qualityassurance

Complete thread:

• Acceptance criteria of analytical run qualityassurance 2021-10-18 07:00 
  • Acceptance criteria of analytical run ElMaestro 2021-10-18 08:35
  • Acceptance criteria of analytical run dshah 2021-10-18 12:36
    • Acceptance criteria of analytical run qualityassurance 2021-10-19 15:25
      • Acceptance criteria of analytical run Ohlbe 2021-10-19 18:54
        • Acceptance criteria of analytical runqualityassurance 2021-10-21 16:51
  • Acceptance criteria of analytical run Ohlbe 2021-10-18 14:43
    • ’Percentage’ of few values Helmut 2021-10-20 14:06
      • ’Percentage’ of few values qualityassurance 2021-10-21 16:57