Steady State Bioequivalence Study [Design Issues]

posted by Pharma_88 – India, 2020-01-08 10:07 (385 d 01:50 ago) – Posting: # 21067
Views: 3,836

Hello All,

A case of Steady state bioequivalence study in which dose is administered twice daily from Day XX to Day XX. Suppose Day 01 to Day 07 where on day 07 only morning dose will be administered. My question is what is the ideal pre-dose time points required to collect to get Cpd. As per guideline, at least 3 pre-dose samples are required to collect. But as we are administrating Drug twice daily, its is necessary to collect pre-dose for morning and evening both for few days i.e Day 01 (morning evening), Day 04 (morning evening) and Day 07 (Morning)?

Also suggest for t.i.d. administration.

Appreciate your valuable suggestion in this regards.

Edit: Category changed; see also this post #1[Helmut]

Complete thread:

 Admin contact
21,316 posts in 4,446 threads, 1,489 registered users;
online 6 (1 registered, 5 guests [including 1 identified bots]).
Forum time: Wednesday 11:58 CET (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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