Dose Optimization in Drug Development

AvRajesh Krishna

E-bok

PDF, Engelska, 2006

Del i serien Drugs and the Pharmaceutical Sciences

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Beskrivning

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 dev

Produktinformation

Utgivningsdatum:2006-05-01
Språk:Engelska
Filformat:PDF
Kopieringsskydd:LCP
ISBN:9781420018585
Förlag:Taylor & Francis Inc
Serie:Drugs and the Pharmaceutical Sciences

Utforska kategorier

Medicinsk utrustning och medicinska tekniker inom Medicin
Medicinsk genetik inom Medicin
Farmakologi inom Medicin

Innehållsförteckning

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