Pharmacometrics: The Science of Quantitative Pharmacology / Edition 1

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Overview

Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians.

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Editorial Reviews

From the Publisher
"…this landmark text is the first to pull together and present in one volume the many facets of pharmacometrics." (American Journal of Pharmaceutical Education, Vol 71, No. 4, 2007)
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Product Details

  • ISBN-13: 9780471677833
  • Publisher: Wiley
  • Publication date: 2/16/2007
  • Edition number: 1
  • Pages: 1216
  • Product dimensions: 7.34 (w) x 10.04 (h) x 2.74 (d)

Meet the Author

ENE I. ETTE, PhD, is a Fellow of the American Colleges ofClinical Pharmacy and Clinical Pharmacology. He is thePresident/CEO of Anoixis Corp. and was formerly the senior directorand head of clinical pharmacology at Vertex Pharmaceuticals, Inc.He is also an adjunct professor of applied pharmaceutical sciencesat the University of Rhode Island. Dr. Ette was a pioneerpharmacometric staff in the Office of Clinical Pharmacology andBiopharmaceutics at the Food and Drug Administration, where hedeveloped the popular reference Guidance for Industry: PopulationPharmacokinetics. From 1989 –2001, he was an FDA Consultant.In recognition of his contributions to clinical pharmacy andclinical pharmacology, Dr. Ette is the recipient of The AmericanCollege of Clinical Pharmacy's Russell Miller Award. He is also the2006 recipient of The American College of Clinical Pharmacy'sTherapeutic Frontiers Lecture Award. Dr. Ette is chairman of thepharmacometrics panel of The Annals of Pharmacotherapy editorialboard.

PAUL J. WILLIAMS, PharmD, is a Fellow of the AmericanColleges of Clinical Pharmacy and Clinical Pharmacology andProfessor of Pharmaceutical Sciences and Pharmacy Practice at theThomas J. Long School of Pharmacy and Health Sciences. Dr. Williamsis the Vice President, Strategic Consulting, West Coast Operationsin Anoixis Corp. and was formerly a partner at Trials by Design,LLC, a clinical consulting company, and member of the editorialboard for The Annals of Pharmacotherapy. Dr. Williams is the 2006winner of the University of the Pacific Faculty Research Award, theLong's Faculty Fellowship, and Teacher of the Year.

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Table of Contents

Dedication.

Preface.

Acknowledgements.

Introduction.

Chapter 1. Pharmacometrics: Impacting Drug Development andPharmacotherpay.

I: GENERAL PRINCIPLES.

Chapter 2. General Principles of Programming (Computer andStatistical).

Chapter 3. Validation of Software for PharmacometricAnalyses.

Chapter 4. Linear, Generalized Linear, and NonlinearMixed-Effects Models.

Chapter 5. Bayesian Hierarchical Modeling with Markov ChainMonte Carlo Methods.

Chapter 6. Estimating the Dynamics of Drug RegimenCompliance.

Chapter 7. Graphical Display for Modeling Population Data.

Chapter 8. The Epistemology of Pharmacometrics.

Chapter 9. Data Imputation.

II: POPULATION PHARMACOKINETIC BASIS OF PHARMACOMETRICS.

Chapter 10. Population Pharmacokinetic Estimation Methods.

Chapter 11. Timing and Efficiency in Population Pharmacokinetic/ Pharmacodynamic Data Analysis.

Chapter 12. Designing Population Pharmacokinetic Studies forEfficient Parameter Estimation.

Chapter 13. Population Models for Drug Absorption andEntero-hepatic Recycling.

Chapter 14. Pharmacometric Knowledge Discovery from Clinicaltrial Data Sets.

Chapter 15. Resampling Techniques and Their Application toPharmacometrics.

Chapter 16. The Population Approach to Bioequivalence.

III: PHARMACOKINETICS / PHARMACODYNAMICS RELATIONSHIP BIOMARKERSAND PHARMACOGENOMICS.

Chapter 17. Biomarkers in Drug Development and PharmacometricModeling.

Chapter 18. Analysis of Gene Expression Data.

Chapter 19. Pharmacogenomics and Pharmacokinetic/PharmacodynamicModeling.

Chapter 20. Empirical Pharmacokinetic/PharmacodynamicModels.

Chapter 21. Developing Models of Disease Progression.

Chapter 22. Mechanistic Pharmacokinetic/Pharmacodynamic (PK/PD)Models.

Chapter 23. Mechanistic Pharmacokinetic/Pharmacodynamic ModelsII.

Chapter 24. PK/PD Analysis of Binary (Logistic) OutcomeData.

Chapter 25. Population Pharmacokinetic / PharmacodynamicModeling of Ordered Categorical Longitudinal Data.

Chapter 26. Transition Models in Pharmacodynamics.

Chapter 27. Mixed Effects Modeling of Count Data.

Chapter 28. Mixture Modeling with NONMEM.

IV. CLINICAL TRIAL DESIGNS.

Chapter 29. Designs for First Time-in-Man Studies inNon-Oncology Indications.

Chapter 30. Design for Phase I Studies in Oncology.

Chapter 31. Design and Analysis of Clinical Exposure - ResponseTrials.

V. PHARMACOMETRIC KNOWLEDGE CREATION.

Chapter 32. Pharmacometric Knowledge Creation: TowardsCharacterizing an Unexplored Region of the Response Surface.

Chapter 33. Clinical Trial Simulation: Theory.

Chapter 34. Modeling and Simulation: Planning and Execution.

Chapter 35. Clinical Trial Simulation: Efficacy Trials.

VI: PHARMACOMETRIC SERVICE AND COMMUNICATION.

Chapter 36. Engineering a Pharmacometrics Enterprise.

Chapter 37. Communication of Pharmacometric AnalysisOutcome.

VII: SPECIFIC APPLICATIONS EXAMPLES.

Chapter 38. Pharmacometrics Applications in Population Exposure-Response Data for New Drug Development and Evaluation.

Chapter 39. Pharmacometrics in Pharmacotherapy and DrugDevelopment: Pediatric Application.

Chapter 40. Pharmacometric Methods for Assessing Drug-Induced QTand QTc Prolongations for Non-Antiarrhythmic Drugs.

Chapter 41. Using Pharmacometrics in the Development of BiologicTherapeutic Agents.

Chapter 42. Analysis of Quantic Pharmacokinetic Study: RobustEstimation of Tissue-to-Plasma Ratio.

Chapter 43. Physiologically Based Pharmacokinetic Modeling:Inhalation, Ingestion and Dermal Absorption.

Chapter 44. Modeling of Metablite Pharmacokinetics in a LargePharmacokinetic Data Set: An Application.

Chapter 45. Characterizing Nonlinear Pharmacokinetics: AnExample Scenario for a Therapeutic Protein.

Chapter 46. Development, Evaluation and Applications of InVitro/ In Vivo Correlations: A Regulatory Perspective.

Chapter 47. The Confluence of Pharmacometric Knowledge Discoveryand Creation in the Characterization of Drug Safety.

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Sort by: Showing 1 Customer Reviews
  • Posted September 12, 2009

    Excellent, it's worth every penny paid for the Text book

    An excellent book who wants to learn quantitative pharmacology. it is a book to keep for a lifetime.

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