CRED Understanding Clinical Development 2024

First page Table of contents Next page Last page
Cover Page1
Course Programme2
Speaker Biographies7
Lecture 1: Introduction and Clinical Development in Context9
Lecture 2: Clinical Pharmacokinetics15
Lecture 3: Clinical Pharmacodynamics31
Lecture 4: Optimal Design - Objectives and Issues Relating to Phase II studies42
Lecture 5: Paediatric Investigation Plans58
Lecture 6: Design of Clinical Trials to Support Proof of Efficacy (Phase III)76
Lecture 7: Safety91
Lecture 8: The Perspective of a Regulatory Authority Reviewer108
Case Study115

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