Back to the Top
The following message was posted to: PharmPK
I would like to know if the acceptance criteria are as follow for
bioanalytical run:
1) 4/6 of the calibrators must be within 15% of nominal values.
2) 4/6 of QC must be within 15% of nominal values.
3) QC must have CV less than 15%, no exclusion of QC as is possible for
calibrator.
Thanks
Vuong
Back to the Top
you will find the complete acceptance criteriain the article
Bioanalytical validation - A revisit with a decade
2000, pharm Res v17 pp15511557
basically,
you should use 3 QCS at 3 differents conc assayed twice.(t least 5% QC
relative to the number of tube you assayed
at least 4/6 must be within 15% of their respective nominal value
2/6 may be outside but not replicate at the same concentration.
best regards
Eric MAGNAN
BEAUFOUR IPSEN - Ipsen Pharma Biotech
Dpt Contrôle Qualité/Quality control Dept
Service Pharmacologie/Pharmacology Unit
Tel : 33 (0)4 94 10 76 74 Fax:: 33 (0)4 94 10 76 79
eric.magnan.-at-.beaufour-ipsen.
Back to the Top
The following message was posted to: PharmPK
As detailed in the following publication, the acceptance criteria
outlined
in the article cited by Eric Magnan are not necessarily appropriate for
immunoassays.
Miller, K. J., Bowsher, R. R., Celniker, A., Gibbons, J. A., Gupta, S.,
Lee,
J. W., Smith, W. C. and Weiner, R. S. 2001. Workshop on Bioanalytical
Methods Validation for Macromolecules: Summary Report. Pharm Res. Pharm
Res. 18:1373.
Jacqueline Gibbons, Ph.D.
Pharmaceutical Consultant and Technical Writer
Specializing in Pharmacokinetics and Bioanalytics
148 Ricardo Avenue
Piedmont, CA 94611
510-601-8601
gibbonsj.at.pacbell.net
Back to the Top
The following message was posted to: PharmPK
1. At least 75% of the standard calibrators must be within the
acceptance criteria of your method.
2. 4/6 of QC must be within 15% of nominal values. - This correct.
Also No two QCs at the same level can fail.
QC must have CV less than 15%, no exclusion of QC as is possible for
3. The %CV can be set before validating your method and applied during
your in-study phase. You are correct, the QCs cannot be excluded to
pass an
assay like the calibrators
Binodh
Binodh S. DeSilva
PKDM Dept
Amgen Inc.
(805) 447-5562
Back to the Top
Dear Binodh:
Once you have established that an assay is acceptably precise,
then what do you do with this information? You might look at
Jelliffe RW, Schumitzky A, Van Guilder M, Liu M, Hu L, Maire P, Gomis
P, Barbaut X, and Tahani B: Individualizing Drug Dosage Regimens: Roles
of Population Pharmacokinetic and Dynamic Models, Bayesian Fitting, and
Adaptive Control. Therapeutic Drug Monitoring, 15: 380-393, 1993.
Very best regards,
Roger Jelliffe
Roger W. Jelliffe, M.D. Professor of Medicine,
Division of Geriatric Medicine,
Laboratory of Applied Pharmacokinetics,
USC Keck School of Medicine
2250 Alcazar St, Los Angeles CA 90033, USA
Phone (323)442-1300, fax (323)442-1302, email= jelliffe.-at-.usc.edu
Our web site= http://www.lapk.org
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)