Sampling Time points and Sample Size [Regulatives / Guidelines]

posted by Maitri – India, 2018-03-04 10:59 (1329 d 18:16 ago) – Posting: # 18495
Views: 1,893

» Thanks Jag for the response. I'm writing a protocol to a generic drug. I would like to know how to use half-life or Tmax and figure out or calculate the sampling time points.
»
» Regards
» Sai

Hi Sai,

This sampling should continue for at least three or more terminal elimination half-lives of the drug to capture 90 percent of the relevant AUC. There are some other key parameters to be considered to calculate sampling time points. Blood samples be drawn at appropriate times to describe the absorption, distribution, and elimination phases of the drug. For most drugs FDA recommend that 12 to 18 samples, including a pre-dose sample, be collected per subject per dose. The exact timing for sample collection depends on the nature of the drug and the rate of input from the administered dosage form. The sample collection should be spaced in such a way that the maximum concentration (Cmax) of the drug in the blood and terminal elimination rate constant can be estimated accurately.

Regards,
Maitri

Complete thread:

Activity
 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Sunday 06:15 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5