Back to the Top
The following message was posted to: PharmPK
Hello,
I am a graduate student at the University of Rhode Island working in the
Pharmacokinetics area. I am validating a method for determination of
immunosuppressive agents in blood using LC/MS-MS. I have my
calibration curve
results along with the Q.C’s for 6 days and need to calculate inter and
intraday imprecision.
Please let me know what is the best method to calculate the imprecision
of my
assay method (interday, intraday and total). I would appreciate it if
I could
you could suggest some references in the area in accordance with FDA
guidelines, which would speed up my work.
Many Thanks
Anisha M.
Back to the Top
The following message was posted to: PharmPK
You should examine the guidance for industry available on FDA website.
Both precision and accuracy will have to within the guideline.
http://www.fda.gov/cder/guidance/4252fnl.htm
I included the web address here so you can go directly to it.
Regards
Vuong
Back to the Top
Dear Anisha:
The real question is what use will you make of these indices
once you have them? It is really useful to use determine the SD of an
assay over its entyire working range, and then to actually use that
information to fit each data point by a good index if the credibility
of each point - its Fisher information, the reciprocal of its variance.
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.aaa.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)