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Wednesday, 04/10/2019 7:19:28 PM

Wednesday, April 10, 2019 7:19:28 PM

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"Dose-response Concurrent Control (1.3.3)In a randomized, fixed-dose, dose-response trial, subjects are randomized to one of several fixed-dose groups. Subjects may either be placed on their fixed dose initially or be raised to that dosegradually, but the intended comparison is between the groups on their final dose. Dose-response
6trials are usually double-blind. They MAY include a placebo (zero dose) and/or active control. In a concentration-controlled trial, treatment groups are titrated to several fixed-concentrationwindows; this type of trial is conceptually similar to a fixed-dose, dose-response trial. In a regimen-controlled trial subjects are randomized to two or more regimens of the study drug (e.g.,once vs. twice daily, 3 days vs. 7 days)."

https://www.fda.gov/downloads/guidances/ucm073139.pdf
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