Dose Optimization in Drug Development: 1st Edition (Hardback) book cover

Dose Optimization in Drug Development

1st Edition

Edited by Rajesh Krishna

CRC Press

320 pages | 58 Color Illus. | 68 B/W Illus.

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Hardback: 9781574448085
pub: 2006-05-01
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pub: 2006-05-01
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This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.

Table of Contents

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

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology