Achievement of steady state [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-06-12 12:17 (959 d 01:07 ago) – Posting: # 21530
Views: 1,121

Hi Roy,

❝ Please Help!!!

Is your  !  key jammed?

❝ Please find Below detail for my question,

Since you posted in this category, see also this post #3. Please do your homework first.

Dosing Day: Day 1 to Day 8.

Blood Sample collection on: Day 4 to Last time Point for both period.

You mean on days 4 and 8, right?

Wash out: 10 Days.

Doesn’t make sense. If you attain (pseudo) steady state on day 4, you can immediately switch to the other treatment. EMA MR-GL (2014):

In steady-state studies, the washout period of the previous treatment can overlap with the build-up of the second treatment (direct switching), provided the build-up period is sufficiently long (at least 5 times the terminal half-life).

❝ Pre-dose Blood sample collection for Day1, Day2 and Day3 are required?

On all days.

Whether the steady-state has been achieved is assessed by comparing at least three pre-dose concentrations for each formulation. The apparent half-life should also be taken into account.

FDA ANDA draft (2013):

We recommend that if a steady-state study is recommended, applicants carry out appropriate dosage administration and sampling to document the attainment of steady-state.

There was a consensus at two GBHI-workshops (Amsterdam, April 2018; Bethesda, December 2019) that a statistical assessment is not required. See this presentation.

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