Bioequivalence and Bioavailability Forum

Which method for SS achievement? [Regulatives / Guidelines]

posted by mittyri  – Russia, 2017-07-23 13:52 (3254 d 13:54 ago) – Posting: # 17595
Views: 7,281

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?

Complete thread:

• multiple dose steady state BE and emesis criteria Mahesh M 2017-07-06 06:45 
  • 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