Bioequivalence and Bioavailability Forum

EMA: GL on bioanalytical method validation Rev.1 [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2014-09-19 19:09 (4301 d 09:14 ago) – Posting: # 13543
Views: 5,888

Dear all,

on Sep 15 EMA updated its Guideline on bioanalytical method validation.
The new document reference is EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.*

Changes:

1. Section 4.1.5. ‘Accuracy’
   • old
     […] around 50% of the calibration curve range (medium QC)
     
   • new
     […] around 30 – 50% of the calibration curve range (medium QC)
     
2. Section 6 ‘Incurred samples reanalysis’
   • old
     The concentration obtained for the initial analysis and the concentration obtained by reanalysis should be within 20% of their mean […].
     
   • new
     The concentration obtained for the initial analysis and the concentration obtained by reanalysis should be within 20% of their mean […]. The following equation should be used for the cal­cu­lations:
                                (repeat value – initial value)
          %difference = ──────────────────── ×100
                                           mean value
3. Section 7.1.1.11. ‘Stability of the samples’
   • old
     In addition, long-term freezer stability should be studied at each temperature at which study samples will be stored. A bracketing approach may be considered.
     
   • new
     In addition, long-term freezer stability should be studied at each temperature at which study samples will be stored. A bracketing approach may be considered.

I’m fine with #1/#2. But why #3? If one has already shown stability at –80 ℃ and –20 ℃ – intending to store samples at any temperature in between – that’s an unscientific formalism, IMHO (yes; I’m aware about some Crystal City Conference discussions).
If you are referring to certain sections in your SOPs/protocols/reports (quoting a page-number), beware. The GL has been reformatted (now 23 pages instead of 22).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• EMA: GL on bioanalytical method validation Rev.1Helmut 2014-09-19 17:09 
  • EMA: Guideline on bioanalytical method validation Rev.1 ElMaestro 2014-09-19 17:39
    • EMA: NSA-approach Helmut 2014-09-19 18:02
      • EMA: NSA-approach ElMaestro 2014-09-19 19:28
        • EMA: NSA-approach nobody 2014-09-19 19:41
          • EMA: NSA-approach ElMaestro 2014-09-20 21:41
            • EMA: NSA-approach nobody 2014-09-21 16:59
  • EMA: GL on bioanalytical method validation Rev.1 Ohlbe 2014-09-19 19:20
    • THX! Helmut 2014-09-22 16:34
    • EMA: GL on bioanalytical method validation Rev.1 Roberto 2014-09-23 17:52