SAD and MAD studies are early Phase 1 study designs used to understand how a new drug behaves in humans. This video explains how Single Ascending Dose and Multiple Ascending Dose studies support early decisions on safety, tolerability, pharmacokinetics, dose escalation, and repeat-dose behaviour.
WHAT THIS VIDEO COVERS
• How SAD studies provide the first human read on exposure and tolerability
• How MAD studies assess repeated dosing, accumulation, steady state, and tolerability over time
• Why SAD findings often shape MAD dose levels, sampling schedules, and review points
• How sentinel dosing supports early cohort safety review
• Why timely safety, ECG, adverse event, and PK data are critical for escalation decisions
• When optional elements, such as food-effect work, need clear decision rules
SAD and MAD studies are small, but they can be operationally demanding. Clear escalation rules, reliable data flow, controlled flexibility, and close coordination around dosing and sampling all affect how useful the results are for later dose planning.
At Quanticate, our early phase biometrics teams support sponsors with practical, rigorous input across SAD and MAD studies, from dose escalation review and PK data flow through to analysis-ready outputs for later dose planning.