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Preface; Contents; Editors and Contributors; Systems Modeling; 1 Systems Pharmacology and Pharmacodynamics: An Introduction; Abstract; 1.1 Introduction; 1.2 Systems Theory in Biology and Pharmacokinetics; 1.2.1 Network-Based Pharmacology and Physiological Control Systems; 1.3 Pharmacodynamics; 1.3.1 Population-Based Pharmacology; 1.4 Systems Pharmacology Models; 1.5 Prospectus; References; 2 Role of Systems Modeling in Regulatory Drug Approval; Abstract; 2.1 Introduction; 2.2 Physiologically-Based Pharmacokinetic (PBPK) Modeling; 2.2.1 Drug-Drug and Gene-Drug Interactions
2.2.2 Specific Populations2.3 Mechanism-Based Drug Safety Evaluation Using Systems Pharmacology; 2.3.1 Ontology of Adverse Events; 2.3.2 Databases-Leveraging "Precompetitive" Data; 2.3.3 Initial Test Cases: Cardiotoxicity and Hepatotoxicity; 2.4 Conclusion and Future Directions; References; 3 Quantitative Systems Pharmacology: Applications and Adoption in Drug Development; Abstract; 3.1 Introduction; 3.1.1 Industry Status and Needs; 3.1.2 Quantitative Systems Pharmacology in the Drug Development Context; 3.2 Application of QSP Across the R&D Pipeline
3.2.1 Research and Preclinical Applications3.2.2 Translational Application; 3.2.3 Clinical Application; 3.3 Understanding and Back-Translation of Clinical Findings; 3.4 Safety and Toxicity Predictions and Understanding; 3.5 Mechanistic Disease Platforms; 3.5.1 Rheumatoid Arthritis; 3.5.2 Bone Remodeling; 3.6 Adoption of QSP in Industry; 3.7 Challenges, Considerations and Future Directions for QSP in Industry; References; 4 Systems Pharmacology: An Overview; Abstract; 4.1 Introduction; 4.2 Systems Pharmacology: A Network-Based View of Drug Action
4.3 Systems Pharmacology: Relationships to Personalized and Precision Medicine4.4 Bioinformatics for Systems Pharmacology; 4.4.1 Pharmacogenomics; 4.4.2 Structural Reasoning in Systems Pharmacology; 4.4.2.1 Protein Structure Informs Network Biology; 4.4.2.2 Structural Considerations Guide Drug Discovery; 4.4.2.3 Genomic Variation Imposes Constraints on Networks Through Protein and Drug Structure; 4.5 Network Dynamics in Systems Pharmacology; 4.5.1 Fragile and Robust Nodes; 4.5.2 Sensitivity Analysis to Assess Fragility
4.5.3 Sensitivity Analysis for Discovery of Targets for Combination Therapy4.6 Networks to Pharmacodynamics; 4.7 Systems-Based PK/PD Models; 4.8 Future of Systems Pharmacology; References; 5 Discrete Dynamic Modeling: A Network Approach for Systems Pharmacology; Abstract; 5.1 Introduction; 5.2 Methodology in Discrete Dynamic Modeling; 5.2.1 Constructing the Network; 5.2.2 Determining the Boolean Functions; 5.2.3 Selecting Time Implementation for State Transitions; 5.2.4 Evaluating the Dynamics and Steady-States of the System; 5.2.5 Network Reduction Techniques
2.2.2 Specific Populations2.3 Mechanism-Based Drug Safety Evaluation Using Systems Pharmacology; 2.3.1 Ontology of Adverse Events; 2.3.2 Databases-Leveraging "Precompetitive" Data; 2.3.3 Initial Test Cases: Cardiotoxicity and Hepatotoxicity; 2.4 Conclusion and Future Directions; References; 3 Quantitative Systems Pharmacology: Applications and Adoption in Drug Development; Abstract; 3.1 Introduction; 3.1.1 Industry Status and Needs; 3.1.2 Quantitative Systems Pharmacology in the Drug Development Context; 3.2 Application of QSP Across the R&D Pipeline
3.2.1 Research and Preclinical Applications3.2.2 Translational Application; 3.2.3 Clinical Application; 3.3 Understanding and Back-Translation of Clinical Findings; 3.4 Safety and Toxicity Predictions and Understanding; 3.5 Mechanistic Disease Platforms; 3.5.1 Rheumatoid Arthritis; 3.5.2 Bone Remodeling; 3.6 Adoption of QSP in Industry; 3.7 Challenges, Considerations and Future Directions for QSP in Industry; References; 4 Systems Pharmacology: An Overview; Abstract; 4.1 Introduction; 4.2 Systems Pharmacology: A Network-Based View of Drug Action
4.3 Systems Pharmacology: Relationships to Personalized and Precision Medicine4.4 Bioinformatics for Systems Pharmacology; 4.4.1 Pharmacogenomics; 4.4.2 Structural Reasoning in Systems Pharmacology; 4.4.2.1 Protein Structure Informs Network Biology; 4.4.2.2 Structural Considerations Guide Drug Discovery; 4.4.2.3 Genomic Variation Imposes Constraints on Networks Through Protein and Drug Structure; 4.5 Network Dynamics in Systems Pharmacology; 4.5.1 Fragile and Robust Nodes; 4.5.2 Sensitivity Analysis to Assess Fragility
4.5.3 Sensitivity Analysis for Discovery of Targets for Combination Therapy4.6 Networks to Pharmacodynamics; 4.7 Systems-Based PK/PD Models; 4.8 Future of Systems Pharmacology; References; 5 Discrete Dynamic Modeling: A Network Approach for Systems Pharmacology; Abstract; 5.1 Introduction; 5.2 Methodology in Discrete Dynamic Modeling; 5.2.1 Constructing the Network; 5.2.2 Determining the Boolean Functions; 5.2.3 Selecting Time Implementation for State Transitions; 5.2.4 Evaluating the Dynamics and Steady-States of the System; 5.2.5 Network Reduction Techniques