Spring Intro 2023

03/03/2023

Legal environment and its consequences

New MAA – Article 8.3 – Full application • Single ascending dose and multiple ascending dose PK and safety • Dose-response studies • Randomized, double-blind, placebo/active controlled study

9 Understanding Clinical Development Program, March 2022

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The various study designs

• Superiority study

placebo controlled active controlled

• Non-inferiority trial • Switching form non-inferiority to superiority

10 Understanding Clinical Development Program, March 2022

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