Integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development

목차 (Table of Contents)

• CONTENTS
• INTRODUCTION = xv
• SECTION Ⅰ INTRODUCTION
• 1. Rationale for the Effective Use of Pharmacokinetics and Pharmacodynamics in Early Drug Development / Carl C. Peck = 1
• 2. The Case for Preclinical Pharmacodynamics / Gerhard Levy = 7
• 3. Utility of Kinetic, Dynamic, and Metabolic Data in Nonclinical Pharmacology／Toxicology Studies / Judi Weissinger = 15
• SECTION Ⅱ PRECLINICAL PHARMACOKINETIC & PHARMACODYNAMIC STUDIES
• 4. Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, protein Binding, Mass Balance, Animal Models) / Glenna G. Fitzgerald = 23
• 5. Nonclinical Considerations : Disposition of Drugs / Martin David Green = 33
• 6. Use of Acute Toxicity Data in the Design and Interpretation of Subchronic and Chronic Toxicity Studies / Karl K. Rozman = 39
• 7. Use of Pharmacokinetics and Pharmacodynamics in Preclinical Studies to Guide Dosage Escalation Schemes in Phase Ⅰ Studies of Anticancer Drugs / Jerry M. Collins = 49
• 8. Use of Toxicokinetic Principles in Drug Development : Bridging Preclinical and Clinical Studies / Mauricio Leal ; Avraham Yacobi ; Vijay K. Batra = 55
• SECTION Ⅲ METHODOLOGY FOR PRECLINICAL PHARMACODYNAMIC STUDIES
• 9. Preclinical Pharmacodynamics of Central Nervous System Active Agents / Meindert Danhof ; Jaap W. Mandama ; Arendien Hoogerkamp = 69
• 10. Preclinical Pharmacodynamics of antihypertensives / Robert A. Branch ; Edwin K. Jackson = 81
• 11. Preclinical Pharmacodynamics of Anxiolytics : Effects of chronic Benzodiazepine Administration / Lawrence G. Miler = 91
• 12. Guidelines for Development of a New Diuretic Agent / D. Craig Brater = 97
• 13. Preclinical Pharmacodynamics of Anti - Inflammatory Drugs / Asoke Mukherjee ; Conrad Chen ; Lucy Jean ; Claude B. Coutinho = 105
• SECTION Ⅳ PRECLINICAL & CLINICAL PHARMACOKINETICS
• 14. The Role of Pharmacokinetics in the Drug Development Process / Leslie Z. Benet = 115
• 15. Implementation of an Effective Pharmacokinetics Research Program in Industry / Avraham Yacobi ; Vijay K. Batra ; Robert Desjardins ; Robert D. Faulkner ; Gabriela Nicolau ; William R. Pool ; Anita Shah ; Alfred P. Tonelli = 125
• 16. Pharmacoepidemiology, Population Pharmacokinetics and New Drug Development / Thaddeus H. Grasela ; Edward J. Antal = 137
• 17. Assessment of Pharmacokinetic Drug Interactions in Clinical Drug Development / Jerome J. Schentag = 149
• SECTION Ⅴ CLINICAL PHARMACODYNAMICS
• 18. Pharmacokinetic／Pharmacodynamic Models and Methods / Davide Verotta ; Lewis B. Sheiner = 159
• 19. Pharmacokinetic and Pharmacodynamic Modeling Applied to Anesthetic Drugs / Donald R. Stanski = 179
• 20. Pharmacodynamic／harmacokinetic Relationships for Rapidly Acting Drugs (NSAIDS) in Rheumatoid Arthritis : Problems and Preliminary Solutions / Daniel E. Furst = 193
• 21. The Value of Plasma - Warfarin Measurement / Robert A. O'Reilly = 201
• 22. Clinical Pharmacodynamics of Cardiovascular Agents : Focus on Sudden Cardiac Death / Dan M. Roden = 207
• 23. The Benzodiazepines : Kinetic - Dynamic Relationships / David J. Greenblatt = 217
• SECTION Ⅵ APPLICATION OF PHARMACODYNAMICS & PHARMACOKINETICS IN THE DRUG DEVELOPMENT PROCESS
• 24. The Integration of Pharmacodynamics and Pharmacokinetics in Rational Drug Development / Sally Usdin Yasuda ; Sorell L. Schwartz ; Anton Wellstein ; Raymond L. Woosley = 225
• 25. Concentration - Controlled Trials : Basic Concepts, Design, and Implementation / Lilly Sanathanan ; Carl C. Peck = 239
• SECTION Ⅶ SUMMARY REPORT
• 26. Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development = 249
• Author Index = 265
• Subject Index = 267