Module 9 2024

05/09/2024

Sensitive Population

REFERENCE TRIAL

Frogs treated with anti-jumping drug

Frogs treated with placebo

The Organisation for Professionals in Regulatory Affairs

51

Insensitive Population

BIOSIMILAR TRIAL

Sick frogs treated with originator anti jumping drug

Sick frogs treated with biosimilar anti jumping drug

Effect seems the same. But do these drugs have comparable effect? This is a different population to the reference trial and these frogs are not inclined to jump even if untreated

The Organisation for Professionals in Regulatory Affairs

52

26