James Swarbrick (ed.)

Dose Optimization in Drug Development

Herausgeber: Krishna, Rajesh

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 318
• Erscheinungstermin: 1. Mai 2006
• Englisch
• Abmessung: 235mm x 157mm x 22mm
• Gewicht: 613g
• ISBN-13: 9781574448085
• ISBN-10: 1574448080
• Artikelnr.: 22442921

Autorenporträt

Rajesh Krishna

Inhaltsangabe

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