Contents

Introduction 41

Pharmacodynamic Biomarkers 42

Pharmacodynamic Biomarker Method Validation 44

Pharmacodynamic Biomarker Evaluation 47

Early Clinical Drug Development 48

Transitioning of Pharmacodynamic Biomarkers from Discovery to

Development 49

Using Pharmacodynamic Biomarkers in Early Clinical Drug

Development 50

Conclusion 51

References 52

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