Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development [electronic resource] /

Rationale for the Effective Use of Pharmacokinetics and Pharmacodynamics in Early Drug Development -- The Case for Preclinical Pharmacodynamics -- Utility of Kinetic, Dynamic, and Metabolic Data in Nonclinical Pharmacology/Toxicology Studies -- Preclinical Pharmacokinetic & Pharmacodynamic Studies -- Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal Models) -- Nonclinical Considerations: Disposition of Drugs -- Use of Acute Toxicity Data in the Design and Interpretation of Subchronic and Chronic Toxicity Studies -- Use of Pharmacokinetics and Pharmacodynamics in Preclinical Studies to Guide Dosage Escalation Schemes in Phase I Studies of Anticancer Drugs -- Use of Toxicokinetic Principles in Drug Development: Bridging Preclinical and Clinical Studies -- Methodology for Preclinical Pharmacodynamic Studies -- Preclinical Pharmacodynamics of Central Nervous System Active Agents -- Preclinical Pharmacodynamics of Antihypertensives -- Preclinical Pharmacodynamics of Anxiolytics: Effects of Chronic Benzodiazepine Administration -- Guidelines for Development of a New Diuretic Agent -- Preclinical Pharmacodynamics of Anti-Inflammatory Drugs -- Preclinical & Clinical Pharmacokinetics -- The Role of Pharmacokinetics in the Drug Development Process -- Implementation of an Effective Pharmacokinetics Research Program in Industry -- Pharmacoepidemiology, Population Pharmacokinetics and New Drug Development -- Assessment of Pharmacokinetic Drug Interactions in Clinical Drug Development -- Clinical Pharmacodynamics -- Pharmacokinetic/Pharmacodynamic Models and Methods -- Pharmacokinetic and Pharmacodynamic Modeling Applied to Anesthetic Drugs -- Pharmacodynamic/Pharmacokinetic Relationships for Rapidly Acting Drugs (NSAIDS) in Rheumatoid Arthritis: Problems and Preliminary Solutions -- The Value of Plasma-Warfarin Measurement -- Clinical Pharmacodynamics of Cardiovascular Agents: Focus on Sudden Cardiac Death -- The Benzodiazepines: Kinetic-Dynamic Relationships -- Application of Pharmacodynamics & Pharmacokinetics in the Drug Development Process -- The Integration of Pharmacodynamics and Pharmacokinetics in Rational Drug Development -- Concentration-Controlled Trials: Basic Concepts, Design, and Implementation -- Summary Report -- Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development.

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Bibliographic Details
Main Authors: Yacobi, Avraham. editor., Skelly, Jerome P. editor., Shah, Vinod P. editor., Benet, Leslie Z. editor., SpringerLink (Online service)
Format: Texto biblioteca
Language:eng
Published: Boston, MA : Springer US : Imprint: Springer, 1993
Subjects:Medicine., Pharmacy., Pharmacology., Biomedicine., Pharmacology/Toxicology.,
Online Access:http://dx.doi.org/10.1007/978-1-4757-1520-0
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Summary:Rationale for the Effective Use of Pharmacokinetics and Pharmacodynamics in Early Drug Development -- The Case for Preclinical Pharmacodynamics -- Utility of Kinetic, Dynamic, and Metabolic Data in Nonclinical Pharmacology/Toxicology Studies -- Preclinical Pharmacokinetic & Pharmacodynamic Studies -- Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal Models) -- Nonclinical Considerations: Disposition of Drugs -- Use of Acute Toxicity Data in the Design and Interpretation of Subchronic and Chronic Toxicity Studies -- Use of Pharmacokinetics and Pharmacodynamics in Preclinical Studies to Guide Dosage Escalation Schemes in Phase I Studies of Anticancer Drugs -- Use of Toxicokinetic Principles in Drug Development: Bridging Preclinical and Clinical Studies -- Methodology for Preclinical Pharmacodynamic Studies -- Preclinical Pharmacodynamics of Central Nervous System Active Agents -- Preclinical Pharmacodynamics of Antihypertensives -- Preclinical Pharmacodynamics of Anxiolytics: Effects of Chronic Benzodiazepine Administration -- Guidelines for Development of a New Diuretic Agent -- Preclinical Pharmacodynamics of Anti-Inflammatory Drugs -- Preclinical & Clinical Pharmacokinetics -- The Role of Pharmacokinetics in the Drug Development Process -- Implementation of an Effective Pharmacokinetics Research Program in Industry -- Pharmacoepidemiology, Population Pharmacokinetics and New Drug Development -- Assessment of Pharmacokinetic Drug Interactions in Clinical Drug Development -- Clinical Pharmacodynamics -- Pharmacokinetic/Pharmacodynamic Models and Methods -- Pharmacokinetic and Pharmacodynamic Modeling Applied to Anesthetic Drugs -- Pharmacodynamic/Pharmacokinetic Relationships for Rapidly Acting Drugs (NSAIDS) in Rheumatoid Arthritis: Problems and Preliminary Solutions -- The Value of Plasma-Warfarin Measurement -- Clinical Pharmacodynamics of Cardiovascular Agents: Focus on Sudden Cardiac Death -- The Benzodiazepines: Kinetic-Dynamic Relationships -- Application of Pharmacodynamics & Pharmacokinetics in the Drug Development Process -- The Integration of Pharmacodynamics and Pharmacokinetics in Rational Drug Development -- Concentration-Controlled Trials: Basic Concepts, Design, and Implementation -- Summary Report -- Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development.