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Dose optimization in drug development

Author: Rajesh Krishna
Publisher: New York : Informa Healthcare, 2006.
Series: Drugs and the pharmaceutical sciences, v. 161.
Edition/Format:   Print book : EnglishView all editions and formats
Database:WorldCat
Summary:
"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 of 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  Read more...
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Additional Physical Format: Online version:
Dose optimization in drug development.
New York : Informa Healthcare, 2006
(OCoLC)607847208
Online version:
Dose optimization in drug development.
New York : Informa Healthcare, 2006
(OCoLC)607894667
Document Type: Book
All Authors / Contributors: Rajesh Krishna
ISBN: 1574448080 9781574448085
OCLC Number: 62736850
Description: xiv, 293 pages : illustrations ; 24 cm.
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
Series Title: Drugs and the pharmaceutical sciences, v. 161.
Responsibility: edited by Rajesh Krishna.
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