Bioequivalence and Bioavailability Forum • steady state for modified release

steady state for modified release [Regulatives / Guidelines]

posted by Kelen – Brazil, 2019-09-20 18:04 (578 d 16:14 ago) – Posting: # 20636
Views: 3,783

I would like to ask help for understand the objetive of the steady state study when you are comparing a MR formulation with a IR formulation. The objective would be compare the effect of the accumulation? Is there any reason to conduct the study only with de highest dose?

Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

steady state for modified releaseKelen 2019-09-20 20:04 [Regulatives / Guidelines]
- steady state for modified release Helmut 2019-09-23 10:04
  - steady state for modified release apapanas 2020-06-24 14:25
    - Superposition principle Helmut 2020-06-24 14:38
      - Superposition principle apapanas 2020-06-24 15:32