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Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data

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During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that… Click to show full abstract

During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that effects are observed in blinded evaluations of data in a simulated phase I study design.

Keywords: phase studies; feasibility interpreting; studies feasibility; escalations phase; phase; dose escalations

Journal Title: British Journal of Clinical Pharmacology
Year Published: 2022

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