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The primary aim of such studies remains to establish the optimal recommended dose for further trials.
Dose-finding phase I trials seek to determine an optimal recommended dose for a new compound for further testing in phase II trials [ 1, 2].
The optimal recommended dose of 400 mg once daily was confirmed by comparing the actual results of efficacy in phase III study and Monte Carlo simulations (predictions) at the stage just after the phase II study.
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However, because of the small sample sizes, the optimal recommended doses generally are determined imprecisely, especially when allowing intrapatient dose escalation.
Therefore, the conventional metric and endpoint to determine the optimal phase 2 recommended dose is the experienced toxicity [3].
Further to agreeing on the optimal recommended treatment doses, the consensus panel discussed situations in which the optimal effect might not be achieved.
Nowadays, it is increasingly recognised that the recommended dose for further exploration of a drug should be the optimal biological drug dose (OBD) rather than the MTD.
The recommended dose is 1g, twice a day.
RemiFemin's recommended dose is 40 milligrams a day.
(These days, the maximum recommended dose is around 12mg).
The recommended dose is 1,000 mg, twice a day.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com