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End User License Agreement
by Diane R. Mould, Honghui Zhou
Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
Cover
About the Editors
Foreword
References
Preface
1 Disease Interception in Autoimmune Diseases: From a Conceptual Framework to Practical Implementation
1.1 Introduction to Disease Interception
1.2 Disease Interception in Autoimmune Diseases
1.3 Progress in Modulation of the Adaptive Immune Response in Autoimmune Inflammatory Diseases
1.4 The Complex Interplay between the Specificity of the Pathogenic Immune Repertoire and Its Sculpting by the Environment – Implications for Disease Interception
1.5 Clinical Application and Concluding Remarks
Acknowledgments
References
2 The Role of Biomarkers in Treatment Algorithms for Ulcerative Colitis (UC)
2.1 Background
2.2 Histology
2.3 Treatment Algorithms
2.4 Assessing Response to Therapy
2.5 Predicting Relapse
2.6 Summary
References
3 Mechanism and Physiologically Based PK/PD Model in Assisting Translation from Preclinical to Clinical: Understanding PK/PD of Therapeutic Proteins at Site‐of‐Action
3.1 Introduction
3.2 Biologic Distribution to Tissue Site of Action
3.3 Target Engagement of Biologics at Site of Action
3.4 Translational Application of Mechanistic PBPK Modeling
3.5 Conclusion
References
4 Application of Minimal Anticipated Biological Effect Level (MABEL) in Human Starting Dose Selection for Immunomodulatory Protein Therapeutics – Principles and Case Studies
4.1 Introduction
4.2 Safety and Immune‐Related Toxicities of Immunomodulatory Protein Therapeutics
4.3 Uncertainties of Toxicology Approach in FIH Safe Starting Dose Selection for Immunomodulatory Protein Therapeutics
4.4 Incorporating Mabel Approach in FIH Starting Dose Selection for High‐Risk Immunomodulatory Protein Therapeutics
4.5 Case Studies of Mabel Calculation
4.6 Discussion and Conclusion
References
5 5Model‐Based Meta‐Analysis Use in the Development of Therapeutic Proteins
5.1 Introduction
5.2 Types of MBMA and Database Considerations
5.3 Data Analytic Models Useful for MBMA
5.4 Example 1: MBMA in Inflammatory Bowel Disease
5.5 MBMA Literature Search
5.6 Kinetic‐Pharmacodynamic Models
5.7 MBMA Implications for Inflammatory Bowel Disease
5.8 Example 2: MBMA in Rheumatoid Arthritis
5.9 Conclusion
References
6 Utility of Joint Population Exposure–Response Modeling Approach to Assess Multiple Continuous and Categorical Endpoints in Immunology Drug Development
6.1 Introduction
6.2 Latent Variable Indirect Response Models
6.3 Residual Correlation Modeling Between a Continuous and a Categorical Endpoint
6.4 Structural Correlation Modeling Between a Continuous Endpoint and a Categorical Endpoint
6.5 Conclusion
References
7 Modeling Approaches to Characterize Target‐Mediated Pharmacokinetics and Pharmacodynamics for Therapeutic Proteins
7.1 Introduction
7.2 Target‐Mediated Drug Disposition Model
7.3 Data and Practical Considerations
7.4 What to Expect from the Concentration–Time Course
7.5 Approximations of the TMDD Model
7.6 Identifiability of Model Parameters
7.7 Summary
References
8 Tutorial: Numerical (NONMEM) Implementation of the Target‐Mediated Drug Disposition Model
8.1 Introduction
8.2 Notations and Data
8.3 NONMEM Code for TMDD Model and Approximations
8.4 How to Select Correct Approximation
8.5 Numerical Implementation
8.6 Summary
References
Appendix Diagnostic Plots
9 Translational Considerations in Developing Bispecific Antibodies: What Can We Learn from Quantitative Pharmacology?
9.1 Introduction
9.2 Quantitative Pharmacokinetic Considerations of BsAbs
9.3 Preclinical Considerations
9.4 Translational Considerations
9.5 Immunogenicity
9.6 Clinical Development of BsAbs
9.7 Conclusion
References
10 Application of Pharmacometrics and Systems Pharmacology to Current and Emerging Biologics in Inflammatory Bowel Diseases
10.1 Introduction
10.2 Pharmacological Approaches for the Treatment of IBD
10.3 Mathematical Models in IBD
10.4 Role of FDA in the Drug Development of Biologics in the Treatment of IBD
10.5 Summary
References
11 Pharmacokinetics‐Based Dosing for Therapeutic Monoclonal Antibodies in Inflammatory Bowel Disease
11.1 Inflammatory Bowel Disease
11.2 Population Pharmacokinetics
11.3 Exposure–Response
11.4 Exposure‐Based Dosing Strategies
11.5 Discussion
References
12 Pharmacokinetics‐Based Dosing Strategies for Therapeutic Proteins in Inflammatory Bowel Disease
12.1 Introduction
12.2 The Need for Understanding and Controlling Variability in Exposure
12.3 History of Dose Individualization
12.4 Bayesian Methods for Dose Individualization
12.5 Clinical Need for Improved Dosing with mAbs
12.6 Expectations for Bayesian Adaptive Dosing
12.7 Summary and Conclusions
References
13 Quantitative Pharmacology Approach to Select Optimal Dose and Study the Important Factors in Determining Disposition of Therapeutic Monoclonal Antibody in Pediatric Subjects – Some Considerations
13.1 Introduction
13.2 Pharmacokinetics of Therapeutic Monoclonal Antibody in Pediatric Population
13.3 Quantitative Pharmacology Considerations to Select Optimal Pediatric Dose of mAbs Based on Adult PK Studies
13.4 Using mPBPK Model to Study the Effects of FcRn Developmental Pharmacology on the PK of mAbs in Pediatric Subjects
References
14 Quantitative Pharmacology Assessment Strategy Therapeutic Proteins in Pediatric Subjects – Challenges and Opportunities
14.1 Introduction
14.2 Extrapolation of Efficacy
14.3 Initiation of Pediatric Trials
14.4 Trial Design Considerations
14.5 Challenges in Pediatric Trials for First‐in‐Class vs. Follow‐on Drug‐in‐Class
References
15 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins for Plaque Psoriasis – Guselkumab
15.1 Introduction
15.2 Understanding of Exposure–Response (ER) Relationship of Guselkumab in Psoriasis
15.3 Dose Selection for Guselkumab in Psoriasis
15.4 Quantitative Pharmacology in Post‐submission Support
15.5 Conclusion
References
16 Vedolizumab—A Case Example of Using Quantitative Pharmacology in Developing Therapeutic Biologics in Inflammatory Bowel Disease
Abbreviations
16.1 Introduction
16.2 Dose Selection for Adult Patients in Phase 3 Trials
16.3 Pharmacokinetic Profile of Vedolizumab
16.4 Population Pharmacokinetics in Phase 1 and 2 Trials
16.5 Comparison of Simulated vs. Measured Vedolizumab Trough Concentrations
16.6 Population Pharmacokinetics in Phase 3 Trials
16.7 Dose Selection for Pediatric Populations
16.8 Exposure–Response Analysis
16.9 Logistic Regression Analyses
16.10 Exposure–Response: Causal Inferences
16.11 Conclusion
Disclosure
References
17 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Systemic Lupus Erythematosus – Belimumab
17.1 Introduction
17.2 Overview of Supporting Data and Methods
17.3 Body Size Characterizations and Impact on Switching from Weight Proportional to Fixed Dosing
17.4 The Yin and Yang of FcRn – Opposing Effect of Albumin and IgG on mAb Clearance
17.5 Lost in Filtration – Renal Contributions to mAb Clearance
17.6 Conclusion
References
18 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Multiple Sclerosis – Peginterferon Beta‐1a, Daclizumab Beta, Natalizumab
18.1 Introduction
18.2 Application of Quantitative Clinical Pharmacology for Dosing Regimen Recommendation of Peginterferon Beta‐ 1a
18.3 Population PK/PD Analyses of Daclizumab Beta and Phase 3 Dose Selection
18.4 Model‐Based Approach for the Clinical Development of Subcutaneous Natalizumab
18.5 Summary
References
Index
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