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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:   eBook : Document : EnglishView all editions and formats
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 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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Dose optimization in drug development.
New York : Informa Healthcare, 2006
(DLC) 2005046645
(OCoLC)62736850
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Rajesh Krishna
ISBN: 9781420018585 1420018582
OCLC Number: 143065488
Reproduction Notes: Electronic reproduction. [S.l.] : HathiTrust Digital Library, 2010. MiAaHDL
Description: 1 online resource (xiv, 293 pages) : illustrations.
Details: Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002.
Contents: Front Cover; Foreword; Preface; Contents; Contributors; 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 (FIH) Trials-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 Perspective7. PK and PD Variability-Estimation and Appraisal of Its Impact on Dose Optimization with an Example of Gender Differences; 8. Pharmacogenetics (PGx) 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 III; 11. Dose Optimization Strategy for Stratteraw, a CYP2D6 Substrate.
Series Title: Drugs and the pharmaceutical sciences, v. 161.
Responsibility: edited by Rajesh Krishna.
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