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 Confidentiality Notice: This is a medical communication. This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain privileged and confidential information. Any unauthorized review, use, copying, saving, re-transmission, disclosure or distribution is strictly prohibited. If you are not the intended recipient, please contact the author by reply email and destroy all original and copies of this email message. ________________________________ This e-mail may contain confidential, personal and/or health information(information which may be subject to legal restrictions on use, retention and/or disclosure) for the sole use of the intended recipient. Any review or distribution by anyone other than the person for whom it was originally intended is strictly prohibited. If you have received this e-mail in error, please contact the sender and delete all copies.
