CRED Understanding Clinical Development 2024

11/10/2024

Other Phase I Studies: Clinical Pharmacology Studies to Support Regulatory Package

Food Interaction

Absolute bioavailability

Organ Impairment

Drug Interaction

Effect of genetics and ethnicity

Special Populations

Effect of Age & Gender

Pharmacokinetics is a primary objectives in all these studies

The Organisation for Professionals in Regulatory Affairs

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Phase II - Patient Studies

Focusing on a small number of patients

Safety and efficacy

Evaluation of Pharmacokinetics and Pharmacodynamics in patient population

Measurement of in patient population

Proof of concept/principle (POC/POP)

Dose range finding study

Provide information to enable exploration of exposure/dose – response (PK/PD) relationships

To ensure robust dose selection for larger Phase III patient trials

The Organisation for Professionals in Regulatory Affairs

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