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

posted by jag009  – NJ, 2020-02-03 20:15  – Posting: # 21132
Views: 1,001

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

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