CRED Understanding Clinical Development 2024

08/10/2024

OBJECTIVES AND CHALLENGES OF A TRADITIONAL Ph 2 STUDY

The Organisation for Professionals in Regulatory Affairs

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Phase 2 Objectives

– Proof of Concept – Preliminary safety and tolerability – Investigate relevant endpoints – Dose Optimization; dose/exposure response relationship (PK/PD assessment) – Other considerations (DDI, food effect, specific safety -renal/hepatic)

The Organisation for Professionals in Regulatory Affairs

10

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