Spring Intro 2023

16/02/2023

Single rising / ascending dose = SRD / SAD Multiple rising / ascending dose = MRD / MAD

Rising ascending dose studies

Basic safety: Is it safe to use in Phase II?

Typical characteristics:

• Healthy volunteers • Successive small cohorts • Dose increases with each cohort • Often 6 active + 2 placebo • Often single exposure • Safety assessments only • Very careful medical supervision

Ph I

Ph IIa

Ph IIb

Ph III

Ph IIIb/IV

PMS

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15

Cross-over design

Period 1

Period 2

Test drug

Test drug

Control

Control

Washout

• Each subject receives both treatments (acts as own control) • Statistically powerful – trials can be smaller

The Organisation for Professionals in Regulatory Affairs

16