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

posted by jag009  – NJ, 2020-02-03 21:15 (1541 d 05:38 ago) – Posting: # 21132
Views: 3,782

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
22,993 posts in 4,828 threads, 1,656 registered users;
60 visitors (0 registered, 60 guests [including 10 identified bots]).
Forum time: 03:54 CEST (Europe/Vienna)

So far as I can remember,
there is not one word in the Gospels
in praise of intelligence.    Bertrand Russell

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