Dose Optimization in Drug Development edited by Rajesh Krishna

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Dose Optimization in Drug Development
edited by Rajesh Krishna

2006 � 320 pages

Dose Optimization in Drug Developmentprovides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications.

Features:

• Focuses on two key interfaces in new drug development: transition from preclinical to Phase I clinical development and transition from Phase IIA/IIB proof-of-concept to Phase IIB/III pivotal efficacy trials
• Promotes innovative clinical trial designs that may allow for a more optimal strategy for dose selection
• Covers procedures and best practices in biomarker validation and qualification
• Considers the benefits of novel clinical trial designs in clinical pharmacology and experimental medicine
• Analyzes the importance of dose optimization during Phase II/III

Contents

1. Introduction to Dose Optimization in Drug Development
2. Bridging Preclinical and Clinical Development: Disease Progression Modeling in Translational Research
3. Bridging Preclinical and Clinical Development: Biomarker Validation and Qualification
4. Dose Selection for First-In-Human Study: A Regulatory Perspective
5. Novel Clinical Trial Designs in Clinical Pharmacology and Experimental Medicine
6. Biomarkers, Surrogate Endpoints, and Clinical Endpoints in the Development of Cardiovascular Drugs: A Regulatory Perspective
7. Pharmacokinetic and Pharmacodynamic Variability
8. Pharmacogenetics and Dose Response: Dose Individualization
9. Optimal Dose Finding in Drug Development: Approaches and Regulatory Perspectives
10. Optimal Dose Selection in Drug Development: Role of Population Pharmacokinetics in Phase 3
11. Dose Optimization Strategy for Strattera, A CYP2D6 Substrate
12. Pediatric Dose Optimization Using Pharmacokinetics/Pharmacodynamics

Index