question about sampling time
Hello NONMEM users and Dr. Holford
I am a novice when it comes to pop PK simulations-
Our group is planning on a prospective once daily aminoglycoside
pharmacokinetic study in patients with proposed serial time levels post dose
with 30min, 2hr, 4hr, 12hr and 24hr post dose drug levels. We will have only a
small sample size (less than 50 patients) and some patients may not be able to
have samples at all these timepoints from logistical reasons.
I would really appreciate some advice on the following:
1. Is there a number of minimum patients that I need for each sampling
time point for pop pk analysis?
2. For each time point - is it better to have some variability within the
sampling time window e.g. 10-12hr with a few patients with samples distributed
at 10, 11 or 12 hour mark?
3. I have learnt only the basics with NONMEM; I have used WIN NONLIN in
the past - recently I have added their WIN-NLME pop PK software to my
subscriptions - should I use both NONMEM and NLME to run results ? would there
be differences? I suspected that NLME may be easier for novice and students to
catch up during short-student rotations to run simulations then to learn NONMEM
on a 4 week rotation. Any opinions?
Thank you in advance for your help.
Winnie
Winnie Seto, BScPhm, PharmD, MSc, ACPR, R.Ph.
Therapeutic Drug Monitoring Coordinator & Critical Care Unit Pharmacist
Clinical Manager
Department of Pharmacy
The Hospital for Sick Children
555 University Avenue
Toronto, Ontario
Canada M5G 1X8
phone: 416-813-6236
fax: 416-813-5880
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