Dose Optimization in Drug Development
1st Edition
Published on 1. May 2006
Book
Hardback
320 pages
978-1-57444-808-5 (ISBN)
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.
More details
Series
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Academic and Professional Practice & Development
Illustrations
68 s/w Abbildungen, 58 farbige Abbildungen, 4 s/w Photographien bzw. Rasterbilder, 19 s/w Tabellen
19 Tables, black and white; 4 Halftones, black and white; 58 Illustrations, color; 68 Illustrations, black and white
Dimensions
Height: 235 mm
Width: 157 mm
Thickness: 22 mm
Weight
613 gr
ISBN-13
978-1-57444-808-5 (9781574448085)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Rajesh Krishna
Dose Optimization in Drug Development
E-Book
05/2006
1st Edition
CRC Press
€264.99
Available for download
Rajesh Krishna
Dose Optimization in Drug Development
E-Book
05/2006
1st Edition
CRC Press
€264.99
Available for download
Person
Rajesh Krishna
Content
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