{"product_id":"quantitative-pharmacology-and-individualized-therapy-strategies-in-development-of-therapeutic-proteins-for-immunemediated-inflammatory-diseases-9781119289197","title":"Quantitative Pharmacology and Individualized","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eThorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases\u003c\/b\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWith increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic\/pharmacodynamic (PK\/PD) modeling for them. This comprehensive volume answers that need to be addressed.\u003c\/p\u003e \u003cp\u003eFeaturing eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for t\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eList of Contributors xvii\u003c\/p\u003e \u003cp\u003eAbout the Editors xxi\u003c\/p\u003e \u003cp\u003eForeword xxiii\u003c\/p\u003e \u003cp\u003ePreface xxvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Disease Interception in Autoimmune Diseases: From a Conceptual Framework to Practical Implementation \u003c\/b\u003e\u003cb\u003e1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAnish Suri\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction to Disease Interception 1\u003c\/p\u003e \u003cp\u003e1.2 Disease Interception in Autoimmune Diseases 3\u003c\/p\u003e \u003cp\u003e1.3 Progress in Modulation of the Adaptive Immune Response in Autoimmune Inflammatory Diseases 5\u003c\/p\u003e \u003cp\u003e1.4 The Complex Interplay between the Specificity of the Pathogenic Immune Repertoire and Its Sculpting by the Environment – Implications for Disease Interception 8\u003c\/p\u003e \u003cp\u003e1.5 Clinical Application and Concluding Remarks 14\u003c\/p\u003e \u003cp\u003eAcknowledgments 15\u003c\/p\u003e \u003cp\u003eReferences 15\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 The Role of Biomarkers in Treatment Algorithms for Ulcerative Colitis (UC) \u003c\/b\u003e\u003cb\u003e25\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eReena Khanna and Brian G. Feagan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Background 25\u003c\/p\u003e \u003cp\u003e2.2 Histology 32\u003c\/p\u003e \u003cp\u003e2.2.1 Tissue Markers 33\u003c\/p\u003e \u003cp\u003e2.3 Treatment Algorithms 34\u003c\/p\u003e \u003cp\u003e2.3.1 Differentiating Inflammatory and Noninflammatory Disease 34\u003c\/p\u003e \u003cp\u003e2.4 Assessing Response to Therapy 35\u003c\/p\u003e \u003cp\u003e2.5 Predicting Relapse 35\u003c\/p\u003e \u003cp\u003e2.6 Summary 35\u003c\/p\u003e \u003cp\u003eReferences 35\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Mechanism and Physiologically Based PK\/PD Model in Assisting Translation from Preclinical to Clinical: Understanding PK\/PD of Therapeutic Proteins at Site-of-Action \u003c\/b\u003e\u003cb\u003e43\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eXi Chen and Weirong Wang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 43\u003c\/p\u003e \u003cp\u003e3.2 Biologic Distribution to Tissue Site of Action 44\u003c\/p\u003e \u003cp\u003e3.3 Target Engagement of Biologics at Site of Action 50\u003c\/p\u003e \u003cp\u003e3.4 Translational Application of Mechanistic PBPK Modeling 54\u003c\/p\u003e \u003cp\u003e3.5 Conclusion 59\u003c\/p\u003e \u003cp\u003eReferences 59\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Application of Minimal Anticipated Biological Effect Level (MABEL) in Human Starting Dose Selection for Immunomodulatory Protein Therapeutics – Principles and Case Studies \u003c\/b\u003e\u003cb\u003e65\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eHaiqing Wang, Zheng Yang, and Rong Shi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 65\u003c\/p\u003e \u003cp\u003e4.2 Safety and Immune-Related Toxicities of Immunomodulatory Protein Therapeutics 66\u003c\/p\u003e \u003cp\u003e4.3 Uncertainties of Toxicology Approach in FIH Safe Starting Dose Selection for Immunomodulatory Protein Therapeutics 68\u003c\/p\u003e \u003cp\u003e4.4 Incorporating Mabel Approach in FIH Starting Dose Selection for High-Risk Immunomodulatory Protein Therapeutics 71\u003c\/p\u003e \u003cp\u003e4.5 Case Studies of Mabel Calculation 75\u003c\/p\u003e \u003cp\u003e4.6 Discussion and Conclusion 85\u003c\/p\u003e \u003cp\u003eReferences 87\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Model-Based Meta-Analysis Use in the Development of Therapeutic Proteins \u003c\/b\u003e\u003cb\u003e93\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTimothy J. Taylor, Bill Frame, and Angela D. Taylor\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 93\u003c\/p\u003e \u003cp\u003e5.2 Types of MBMA and Database Considerations 94\u003c\/p\u003e \u003cp\u003e5.3 Data Analytic Models Useful for MBMA 96\u003c\/p\u003e \u003cp\u003e5.4 Example 1: MBMA in Inflammatory Bowel Disease 97\u003c\/p\u003e \u003cp\u003e5.5 MBMA Literature Search 99\u003c\/p\u003e \u003cp\u003e5.6 Kinetic-Pharmacodynamic Models 100\u003c\/p\u003e \u003cp\u003e5.7 MBMA Implications for Inflammatory Bowel Disease 116\u003c\/p\u003e \u003cp\u003e5.8 Example 2: MBMA in Rheumatoid Arthritis 117\u003c\/p\u003e \u003cp\u003e5.9 Conclusion 119\u003c\/p\u003e \u003cp\u003eReferences 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Utility of Joint Population Exposure–Response Modeling Approach to Assess Multiple Continuous and Categorical Endpoints in Immunology Drug Development \u003c\/b\u003e\u003cb\u003e125\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eChuanpu Hu and Honghui Zhou\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 125\u003c\/p\u003e \u003cp\u003e6.2 Latent Variable Indirect Response Models 126\u003c\/p\u003e \u003cp\u003e6.3 Residual Correlation Modeling Between a Continuous and a Categorical Endpoint 128\u003c\/p\u003e \u003cp\u003e6.4 Structural Correlation Modeling Between a Continuous Endpoint and a Categorical Endpoint 134\u003c\/p\u003e \u003cp\u003e6.4.1 Application Example: Rheumatoid Arthritis 134\u003c\/p\u003e \u003cp\u003e6.5 Conclusion 145\u003c\/p\u003e \u003cp\u003eReferences 145\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Modeling Approaches to Characterize Target-Mediated Pharmacokinetics and Pharmacodynamics for Therapeutic Proteins \u003c\/b\u003e\u003cb\u003e149\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eLeonid Gibiansky and Ekaterina Gibiansky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 149\u003c\/p\u003e \u003cp\u003e7.2 Target-Mediated Drug Disposition Model 150\u003c\/p\u003e \u003cp\u003e7.3 Data and Practical Considerations 152\u003c\/p\u003e \u003cp\u003e7.4 What to Expect from the Concentration–Time Course 154\u003c\/p\u003e \u003cp\u003e7.5 Approximations of the TMDD Model 157\u003c\/p\u003e \u003cp\u003e7.6 Identifiability of Model Parameters 166\u003c\/p\u003e \u003cp\u003e7.7 Summary 167\u003c\/p\u003e \u003cp\u003eReferences 168\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Tutorial: Numerical (NONMEM) Implementation of the Target-Mediated Drug Disposition Model \u003c\/b\u003e\u003cb\u003e173\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eLeonid Gibiansky and Ekaterina Gibiansky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 173\u003c\/p\u003e \u003cp\u003e8.2 Notations and Data 174\u003c\/p\u003e \u003cp\u003e8.3 NONMEM Code for TMDD Model and Approximations 174\u003c\/p\u003e \u003cp\u003e8.4 How to Select Correct Approximation 179\u003c\/p\u003e \u003cp\u003e8.4.2 Approach Based on Biological Considerations 180\u003c\/p\u003e \u003cp\u003e8.5 Numerical Implementation 181\u003c\/p\u003e \u003cp\u003e8.5.1 Choice of ADVAN Subroutines 181\u003c\/p\u003e \u003cp\u003e8.5.2 Parallel Computing 181\u003c\/p\u003e \u003cp\u003e8.6 Summary 182\u003c\/p\u003e \u003cp\u003eReferences 182\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Translational Considerations in Developing Bispecific Antibodies: What Can We Learn from Quantitative Pharmacology? \u003c\/b\u003e\u003cb\u003e187\u003cbr\u003e \u003c\/b\u003e\u003ci\u003ePradeep B. Lukka, Santosh Wagh, and Bernd Meibohm\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 187\u003c\/p\u003e \u003cp\u003e9.2 Quantitative Pharmacokinetic Considerations of BsAbs 187\u003c\/p\u003e \u003cp\u003e9.3 Preclinical Considerations 189\u003c\/p\u003e \u003cp\u003e9.4 Translational Considerations 196\u003c\/p\u003e \u003cp\u003e9.5 Immunogenicity 197\u003c\/p\u003e \u003cp\u003e9.6 Clinical Development of BsAbs 198\u003c\/p\u003e \u003cp\u003e9.7 Conclusion 200\u003c\/p\u003e \u003cp\u003eReferences 202\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Application of Pharmacometrics and Systems Pharmacology to Current and Emerging Biologics in Inflammatory Bowel Diseases \u003c\/b\u003e\u003cb\u003e209\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSihem Ait-Oudhia, Yi Ting (Kayla) Lien, Sumit Basu, Lawrence Lesko, and Stephan Schmidt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 209\u003c\/p\u003e \u003cp\u003e10.2 Pharmacological Approaches for the Treatment of IBD 215\u003c\/p\u003e \u003cp\u003e10.3 Mathematical Models in IBD 224\u003c\/p\u003e \u003cp\u003e10.4 Role of FDA in the Drug Development of Biologics in the Treatment of IBD 228\u003c\/p\u003e \u003cp\u003e10.5 Summary 231\u003c\/p\u003e \u003cp\u003eReferences 231\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Pharmacokinetics-Based Dosing for Therapeutic Monoclonal Antibodies in Inflammatory Bowel Disease \u003c\/b\u003e\u003cb\u003e243\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eNiels Vande Casteele and William J. Sandborn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Inflammatory Bowel Disease 243\u003c\/p\u003e \u003cp\u003e11.2 Population Pharmacokinetics 244\u003c\/p\u003e \u003cp\u003e11.3 Exposure–Response 246\u003c\/p\u003e \u003cp\u003e11.4 Exposure-Based Dosing Strategies 247\u003c\/p\u003e \u003cp\u003e11.5 Discussion 249\u003c\/p\u003e \u003cp\u003eReferences 251\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Pharmacokinetics-Based Dosing Strategies for Therapeutic Proteins in Inflammatory Bowel Disease \u003c\/b\u003e\u003cb\u003e255\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDiane R.Mould, Richard N. Upton, and Jessica Wojciechowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 255\u003c\/p\u003e \u003cp\u003e12.2 The Need for Understanding and Controlling Variability in Exposure 256\u003c\/p\u003e \u003cp\u003e12.3 History of Dose Individualization 258\u003c\/p\u003e \u003cp\u003e12.4 Bayesian Methods for Dose Individualization 260\u003c\/p\u003e \u003cp\u003e12.5 Clinical Need for Improved Dosing with mAbs 265\u003c\/p\u003e \u003cp\u003e12.6 Expectations for Bayesian Adaptive Dosing 268\u003c\/p\u003e \u003cp\u003e12.7 Summary and Conclusions 277\u003c\/p\u003e \u003cp\u003eReferences 278\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Quantitative Pharmacology Approach to Select Optimal Dose and Study the Important Factors in Determining Disposition of Therapeutic Monoclonal Antibody in Pediatric Subjects – Some Considerations \u003c\/b\u003e285\u003cbr\u003e \u003ci\u003eDeni Hardiansyah and Chee M. Ng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 285\u003c\/p\u003e \u003cp\u003e13.2 Pharmacokinetics of Therapeutic Monoclonal Antibody in Pediatric Population 289\u003c\/p\u003e \u003cp\u003e13.3 Quantitative Pharmacology Considerations to Select Optimal Pediatric Dose of mAbs Based on Adult PK Studies 291\u003c\/p\u003e \u003cp\u003e13.4 Using mPBPK Model to Study the Effects of FcRn Developmental\u003c\/p\u003e \u003cp\u003ePharmacology on the PK of mAbs in Pediatric Subjects 299\u003c\/p\u003e \u003cp\u003eReferences 307\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Quantitative Pharmacology Assessment Strategy Therapeutic Proteins in Pediatric Subjects – Challenges and Opportunities \u003c\/b\u003e\u003cb\u003e315\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJeremiah D. Momper, Andrew Mulberg, Nitin Mehrotra, Dan Turner, William Faubion, Laurie Conklin, Karim Azer, and Marla C. Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 315\u003c\/p\u003e \u003cp\u003e14.2 Extrapolation of Efficacy 315\u003c\/p\u003e \u003cp\u003e14.3 Initiation of Pediatric Trials 321\u003c\/p\u003e \u003cp\u003e14.4 Trial Design Considerations 322\u003c\/p\u003e \u003cp\u003e14.5 Challenges in Pediatric Trials for First-in-Class vs. Follow-on Drug-in-Class 330\u003c\/p\u003e \u003cp\u003eReferences 331\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins for Plaque Psoriasis – Guselkumab \u003c\/b\u003e\u003cb\u003e337\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eZhenling Yao, Yaowei Zhu, Chuanpu Hu, Yang Chen, Shu Li, Bruce Randazzo, Zhenhua Xu, Amarnath Sharma, and Honghui Zhou\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 337\u003c\/p\u003e \u003cp\u003e15.1.1 Pathogenesis of Plaque Psoriasis 337\u003c\/p\u003e \u003cp\u003e15.1.2 Current Treatment Paradigms for Psoriasis 338\u003c\/p\u003e \u003cp\u003e15.2 Understanding of Exposure–Response (ER) Relationship of Guselkumab in Psoriasis 339\u003c\/p\u003e \u003cp\u003e15.3 Dose Selection for Guselkumab in Psoriasis 342\u003c\/p\u003e \u003cp\u003e15.4 Quantitative Pharmacology in Post-submission Support 358\u003c\/p\u003e \u003cp\u003e15.5 Conclusion 359\u003c\/p\u003e \u003cp\u003eReferences 360\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Vedolizumab—A Case Example of Using Quantitative Pharmacology in Developing Therapeutic Biologics in Inflammatory Bowel Disease \u003c\/b\u003e\u003cb\u003e363\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMaria Rosario, Nathanael L. Dirks, Diane R.Mould, Catherine Scholz, Timothy Wyant, Asit Parikh, and Irving Fox\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eAbbreviations 363\u003c\/p\u003e \u003cp\u003e16.1 Introduction 364\u003c\/p\u003e \u003cp\u003e16.2 Dose Selection for Adult Patients in Phase 3 Trials 365\u003c\/p\u003e \u003cp\u003e16.3 Pharmacokinetic Profile of Vedolizumab 366\u003c\/p\u003e \u003cp\u003e16.4 Population Pharmacokinetics in Phase 1 and 2 Trials 368\u003c\/p\u003e \u003cp\u003e16.5 Comparison of Simulated vs. Measured Vedolizumab Trough Concentrations 372\u003c\/p\u003e \u003cp\u003e16.6 Population Pharmacokinetics in Phase 3 Trials 372\u003c\/p\u003e \u003cp\u003e16.7 Dose Selection for Pediatric Populations 374\u003c\/p\u003e \u003cp\u003e16.8 Exposure–Response Analysis 376\u003c\/p\u003e \u003cp\u003e16.9 Logistic Regression Analyses 378\u003c\/p\u003e \u003cp\u003e16.10 Exposure–Response: Causal Inferences 381\u003c\/p\u003e \u003cp\u003e16.11 Conclusion 384\u003c\/p\u003e \u003cp\u003eDisclosure 384\u003c\/p\u003e \u003cp\u003eReferences 384\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Systemic Lupus Erythematosus – Belimumab 389\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eHerbert Struemper\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 389\u003c\/p\u003e \u003cp\u003e17.2 Overview of Supporting Data and Methods 390\u003c\/p\u003e \u003cp\u003e17.3 Body Size Characterizations and Impact on Switching from Weight Proportional to Fixed Dosing 390\u003c\/p\u003e \u003cp\u003e17.4 The Yin and Yang of FcRn – Opposing Effect of Albumin and IgG on mAb Clearance 392\u003c\/p\u003e \u003cp\u003e17.5 Lost in Filtration – Renal Contributions to mAb Clearance 395\u003c\/p\u003e \u003cp\u003e17.6 Conclusion 397\u003c\/p\u003e \u003cp\u003eReferences 398\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Multiple Sclerosis – Peginterferon Beta-1a, Daclizumab Beta, Natalizumab \u003c\/b\u003e\u003cb\u003e401\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eXiao Hu, Yaming Hang, Lei Diao, Kumar K.Muralidharan, and Ivan Nestorov\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 401\u003c\/p\u003e \u003cp\u003e18.2 Application of Quantitative Clinical Pharmacology for Dosing Regimen Recommendation of Peginterferon Beta- 1a 403\u003c\/p\u003e \u003cp\u003e18.3 Population PK\/PD Analyses of Daclizumab Beta and Phase 3 Dose Selection 414\u003c\/p\u003e \u003cp\u003e18.4 Model-Based Approach for the Clinical Development of Subcutaneous Natalizumab 419\u003c\/p\u003e \u003cp\u003e18.5 Summary 431\u003c\/p\u003e \u003cp\u003eReferences 431\u003c\/p\u003e \u003cp\u003eIndex 437\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407029051735,"sku":"9781119289197","price":161.06,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119289197.jpg?v=1730497928","url":"https:\/\/bookcurl.com\/products\/quantitative-pharmacology-and-individualized-therapy-strategies-in-development-of-therapeutic-proteins-for-immunemediated-inflammatory-diseases-9781119289197","provider":"Book Curl","version":"1.0","type":"link"}