Definition:

Subjects in a MAD study receive the same drug multiple times over a certain period, increasing the dose of the study drug at each administration.

A MAD study is a type of phase 1 trial typically performed following a single ascending dose (SAD) study. SAD and MAD studies are done to understand how the body tolerates and processes a drug.

It is recommended to dose subjects sequentially with an appropriate period of observation between dosing of individual subjects (sentinel dosing). This is carried out for each dose level for an adequate period of time. The recent EMA guidance emphasised routine use of sentinel dosing within each dosing cohort, for both single and multiple dosing.

See also: single ascending dose (SAD)

More information:

EMA: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (EMA, 2017)

Design and Conduct Considerations for First‐in‐Human Trials (Clinical and Translational Science, 2019)

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Definition, Encyclopaedia, Guideline, Publication, Phase 1, Regulatory