Bioequivalence and Bioavailability Forum • Which method for SS achievement?

Which method for SS achievement? [Regulatives / Guidelines]

posted by mittyri – Russia, 2017-07-23 13:52 (2802 d 02:50 ago) – Posting: # 17595
Views: 6,440

Hi Helmut,

❝ ❝ […] 3 consecutive day samples to assess steady state then it should be fine as long as you can demonstrate that steady state is achieved (regression analysis).

❝

❝ Been there, done that. Nowadays I don’t recommend it any more.

I'm confused...
Then which method would you recommend instead? :confused:

—
Kind regards,
Mittyri

Complete thread:

multiple dose steady state BE and emesis criteria Mahesh M 2017-07-06 06:45 [Regulatives / Guidelines]
- multiple dose steady state BE and emesis criteria Mahesh M 2017-07-14 12:31
  - multiple dose steady state BE and emesis criteria jag009 2017-07-20 05:15
    - regression of pre-dose concentrations Helmut 2017-07-22 15:12
      - Which method for SS achievement?mittyri 2017-07-23 11:52
- IR and MR: pre-specified! Helmut 2017-07-22 15:33