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Registersteady state for modified release [Regulatives / Guidelines]
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]
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- steady state for modified releaseKelen 2019-09-20 20:04 [Regulatives / Guidelines]
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- steady state for modified release Helmut 2019-09-23 10:04
Ing. Helmut Schütz