EMA: GL on bioanalytical method validation Rev.1 [Regulatives / Guidelines]
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:
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).
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:
- 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)
- old
- 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
- old
- 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.
- old
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
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: GL on bioanalytical method validation Rev.1Helmut 2014-09-19 17:09 [Regulatives / Guidelines]
- 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: NSA-approach ElMaestro 2014-09-20 21:41
- EMA: NSA-approach nobody 2014-09-19 19:41
- EMA: NSA-approach ElMaestro 2014-09-19 19:28
- EMA: NSA-approach Helmut 2014-09-19 18:02
- 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
- EMA: Guideline on bioanalytical method validation Rev.1 ElMaestro 2014-09-19 17:39