CRED Understanding Clinical Development 2024

11/10/2024

Learning Outcomes: Recap

First in human trials guideline

Objectives of clinical pharmacodynamic studies

Mechanism/onset/duration of action

Examples of pharmacodynamic models

Different study designs

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

Biomarkers

Practicalities of clinical pharmacodynamic studies

The Organisation for Professionals in Regulatory Affairs

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QUESTIONS

The Organisation for Professionals in Regulatory Affairs

22

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