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.


  • 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


  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




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