Dose Optimization in Drug Development  book cover
1st Edition

Dose Optimization in Drug Development

Edited By

Rajesh Krishna

ISBN 9781574448085
Published May 1, 2006 by CRC Press
320 Pages 58 Color & 68 B/W Illustrations

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Book Description

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

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