Bioequivalence and Bioavailability Forum • Reference standards

Reference standards [Bioanalytics]

posted by janmacek – Czech Republic, 2015-07-15 11:28 (3573 d 08:12 ago) – Posting: # 15084
Views: 10,134

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

Complete thread:

Reference standards janmacek 2015-02-13 10:57 [Bioanalytics]
- Reference standards ElMaestro 2015-02-13 11:51
  - OECD GLP Helmut 2015-02-13 14:13
  - Reference standards Ionsource 2015-02-16 08:04
- Reference standards Ohlbe 2015-02-13 15:49
  - Reference standards nobody 2015-02-13 19:22
    - Reference standards ElMaestro 2015-02-13 23:00
      - ....got a wicked idea ElMaestro 2015-02-13 23:18
        
        ....got a wicked idea nobody 2015-02-14 12:49
  - Reference standards janmacek 2015-02-16 12:59
    - Reference standardsjanmacek 2015-07-15 09:28
      - "solved" ??? ElMaestro 2015-07-15 10:35