Dose linearity (multiple dose) study is also called Multiple Ascending Dose study. It is one of the earliest studies performed in the clinical development of a drug. It is preceded by an initial Single Ascending Dose study. In a Multiple Ascending Dose study, each subject receives multiple doses of the study drug. “Ascending” indicates that the amount of drug increases for each new cohort of subjects (the dose level ascends as the study goes on).

Multiple Ascending Dose studies are intended to fully characterize the pharmacokinetics of a drug and its metabolites at a steady state, investigate a drug’s accumulation potential, explore its dose proportionality, and determine the Maximum Tolerated Dose (MTD).

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