Pharmacometrics handbook from C.H.I.P.S.

The Science of Quantitative Pharmacology
edited by Ene I. Ette

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.

Edited and written by leaders in the field, this definitive handbook on pharmacometrics:

  • Integrates theory and practice to let the reader apply principles and concepts
  • Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field
  • Is unique in including computer code information with the examples


  1. Pharmacometrics: Impacting Drug Development and Pharmacotherpay

Part I: General Principles

  1. General Principles of Programming (Computer and Statistical)
  2. Validation of Software for Pharmacometric Analyses
  3. Linear, Generalized Linear, and Nonlinear Mixed-Effects Models
  4. Bayesian Hierarchical Modeling with Markov Chain Monte Carlo Methods
  5. Estimating the Dynamics of Drug Regimen Compliance
  6. Graphical Display for Modeling Population Data
  7. The Epistemology of Pharmacometrics
  8. Data Imputation

Part II: Population Pharmacokinetic Basis of Pharmacometrics

  1. Population Pharmacokinetic Estimation Methods
  2. Timing and Efficiency in Population Pharmacokinetic / Pharmacodynamic Data Analysis
  3. Designing Population Pharmacokinetic Studies for Efficient Parameter Estimation
  4. Population Models for Drug Absorption and Entero-hepatic Recycling
  5. Pharmacometric Knowledge Discovery from Clinical trial Data Sets
  6. Resampling Techniques and Their Application to Pharmacometrics
  7. The Population Approach to Bioequivalence

Part III: Pharmacokinetics/Pharmacodynamics Relationship Biomarkers and Pharmacogenomics

  1. Biomarkers in Drug Development and Pharmacometric Modeling
  2. Analysis of Gene Expression Data
  3. Pharmacogenomics and Pharmacokinetic/Pharmacodynamic Modeling
  4. Empirical Pharmacokinetic/Pharmacodynamic Models
  5. Developing Models of Disease Progression
  6. Mechanistic Pharmacokinetic/Pharmacodynamic (PK/PD) Models
  7. Mechanistic Pharmacokinetic/Pharmacodynamic Models II
  8. PK/PD Analysis of Binary (Logistic) Outcome Data
  9. Population Pharmacokinetic / Pharmacodynamic Modeling of Ordered Categorical Longitudinal Data
  10. Transition Models in Pharmacodynamics
  11. Mixed Effects Modeling of Count Data
  12. Mixture Modeling with NONMEM

Part IV: Clinical Trial Designs

  1. Designs for First Time-in-Man Studies in Non-Oncology Indications
  2. Design for Phase I Studies in Oncology
  3. Design and Analysis of Clinical Exposure - Response Trials

Part V: Pharmacometric Knowledge Creation

  1. Pharmacometric Knowledge Creation: Towards Characterizing an Unexplored Region of the Response Surface
  2. Clinical Trial Simulation: Theory
  3. Modeling and Simulation: Planning and Execution
  4. Clinical Trial Simulation: Efficacy Trials

Part VI: Pharmacometric Service and Communication

  1. Engineering a Pharmacometrics Enterprise
  2. Communication of Pharmacometric Analysis Outcome

Part VII: Specific Applications Examples

  1. Pharmacometrics Applications in Population Exposure-Response Data for New Drug Development and Evaluation
  2. Pharmacometrics in Pharmacotherapy and Drug Development: Pediatric Application
  3. Pharmacometric Methods for Assessing Drug-Induced QT and QTc Prolongations for Non-Antiarrhythmic Drugs
  4. Using Pharmacometrics in the Development of Biologic Therapeutic Agents
  5. Analysis of Quantic Pharmacokinetic Study: Robust Estimation of Tissue-to-Plasma Ratio
  6. Physiologically Based Pharmacokinetic Modeling: Inhalation, Ingestion and Dermal Absorption
  7. Modeling of Metablite Pharmacokinetics in a Large Pharmacokinetic Data Set: An Application
  8. Characterizing Nonlinear Pharmacokinetics: An Example Scenario for a Therapeutic Protein
  9. Development, Evaluation and Applications of In Vitro/ In Vivo Correlations: A Regulatory Perspective
  10. The Confluence of Pharmacometric Knowledge Discovery and Creation in the Characterization of Drug Safety


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The Science of Quantitative Pharmacology
edited by Ene I. Ette

2007 1,205 pages $174.00 + shipping
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