CRED Understanding Clinical Development 2024

11/10/2024

Clinical Pharmacodynamics

Marco Siccardi, ESQlabs

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

First in human trials

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Guidelines

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• Objectives of clinical pharmacodynamic studies

Mechanism/onset/duration of action

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Examples of pharmacodynamic models

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Different study designs

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• Identification of sub-group differences e.g. disease-related, gender, age, race, geography (racial sub-populations)

Biomarkers

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• Practicalities of clinical pharmacodynamic studies

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