Reference standards [Bioanalytics]

posted by janmacek – Czech Republic, 2015-07-15 11:28 (3494 d 21:54 ago) – Posting: # 15084
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Hi all,

I asked EMA on this problem and after two months they responded that they consider updating the guideline on bioanalytical method validation. They really did so by eliminating the reference to European Pharmacopoeia Certified Reference Standards, EPCRS (see EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2) and the problem is thus solved. In the future studies the EPCRS cannot be used anymore.

Best regards,
Jan

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