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

Contents

1. Pharmacometrics: Impacting Drug Development and Pharmacotherpay

Part I: General Principles

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

Part II: Population Pharmacokinetic Basis of Pharmacometrics

10. Population Pharmacokinetic Estimation Methods
11. Timing and Efficiency in Population Pharmacokinetic / Pharmacodynamic Data Analysis
12. Designing Population Pharmacokinetic Studies for Efficient Parameter Estimation
13. Population Models for Drug Absorption and Entero-hepatic Recycling
14. Pharmacometric Knowledge Discovery from Clinical trial Data Sets
15. Resampling Techniques and Their Application to Pharmacometrics
16. The Population Approach to Bioequivalence

Part III: Pharmacokinetics/Pharmacodynamics Relationship Biomarkers and Pharmacogenomics

17. Biomarkers in Drug Development and Pharmacometric Modeling
18. Analysis of Gene Expression Data
19. Pharmacogenomics and Pharmacokinetic/Pharmacodynamic Modeling
20. Empirical Pharmacokinetic/Pharmacodynamic Models
21. Developing Models of Disease Progression
22. Mechanistic Pharmacokinetic/Pharmacodynamic (PK/PD) Models
23. Mechanistic Pharmacokinetic/Pharmacodynamic Models II
24. PK/PD Analysis of Binary (Logistic) Outcome Data
25. Population Pharmacokinetic / Pharmacodynamic Modeling of Ordered Categorical Longitudinal Data
26. Transition Models in Pharmacodynamics
27. Mixed Effects Modeling of Count Data
28. Mixture Modeling with NONMEM

Part IV: Clinical Trial Designs

29. Designs for First Time-in-Man Studies in Non-Oncology Indications
30. Design for Phase I Studies in Oncology
31. Design and Analysis of Clinical Exposure - Response Trials

Part V: Pharmacometric Knowledge Creation

32. Pharmacometric Knowledge Creation: Towards Characterizing an Unexplored Region of the Response Surface
33. Clinical Trial Simulation: Theory
34. Modeling and Simulation: Planning and Execution
35. Clinical Trial Simulation: Efficacy Trials

Part VI: Pharmacometric Service and Communication

36. Engineering a Pharmacometrics Enterprise
37. Communication of Pharmacometric Analysis Outcome

Part VII: Specific Applications Examples

38. Pharmacometrics Applications in Population Exposure-Response Data for New Drug Development and Evaluation
39. Pharmacometrics in Pharmacotherapy and Drug Development: Pediatric Application
40. Pharmacometric Methods for Assessing Drug-Induced QT and QTc Prolongations for Non-Antiarrhythmic Drugs
41. Using Pharmacometrics in the Development of Biologic Therapeutic Agents
42. Analysis of Quantic Pharmacokinetic Study: Robust Estimation of Tissue-to-Plasma Ratio
43. Physiologically Based Pharmacokinetic Modeling: Inhalation, Ingestion and Dermal Absorption
44. Modeling of Metablite Pharmacokinetics in a Large Pharmacokinetic Data Set: An Application
45. Characterizing Nonlinear Pharmacokinetics: An Example Scenario for a Therapeutic Protein
46. Development, Evaluation and Applications of In Vitro/ In Vivo Correlations: A Regulatory Perspective
47. The Confluence of Pharmacometric Knowledge Discovery and Creation in the Characterization of Drug Safety

Index

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