Study which captures SD and SS PK Profiles [Design Issues]

posted by jag009  – NJ, 2020-02-03 21:15 (1536 d 20:59 ago) – Posting: # 21132
Views: 3,752

Hi all,

I seek your opinion on the follow:
If you are being asked to design a PK study to capture single dose and SS PK profiles for a drug product, which dosing and sampling design would you use?
A) On Day 1 dosing, PK sample from time 0 to X (wait a day to a few days or whatever so to capture 1/2 life). Repeat dosing for x number of days to hit steady state (while collecting predose samples to assess SS), then capture SS pk profile from 0 - x hours as per dosing interval (if dosing interval 6 hours then stop at 12 hrs).
B) Capture day 1 PK from time 0 to end of dosing interval, repeat dosing for x # of days (base on dosing interval) to hit SS. On last day of dosing capture time 0 - x (x = whatever hrs needed to fully capture the elimination phase + half-life).

I have seen both designs but I (and my former bosses) prefer method A. The only drawback I see from A is it takes longer time.

Thx
J

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,661 registered users;
86 visitors (0 registered, 86 guests [including 2 identified bots]).
Forum time: 19:14 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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