ER vs. IR [Design Issues]

posted by Dr_Dan  – Germany, 2019-12-19 09:01 (919 d 20:38 ago) – Posting: # 21004
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Hi Helmut
your statement only holds true in your example with different strengths. If you have only one or the highest IR strength then my statement applies. The once daily (or 8 h) dosing of the ER formulation does not have to mimicry the performance of the multiple dosing of the IR formulation if you can show that there is a well-defined therapeutic window in terms of safety and efficacy and the rate of input is known not to influence the safety and efficacy profile or the risk for tolerance development.
KR
Dan

Kind regards and have a nice day
Dr_Dan

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