Spring Intro 2023

16/02/2023

Cross-over design

Detailed PK: Drug interaction, bioequivalence etc

Typical characteristics:

• Healthy volunteers • Small size (e.g. n=24) • Single or multiple dose • Pharmacokinetic endpoints Not always on critical path (often done in parallel with phase III)

Ph I

Ph IIa

Ph IIb

Ph III

Ph IIIb/IV

PMS

The Organisation for Professionals in Regulatory Affairs

17

Parallel-group design

Test drug

Control arm (active comparator)

Statistical comparisons

Control arm (placebo)

The Organisation for Professionals in Regulatory Affairs

18