Quantitative pharmacology and individualized therapy strategies in development of therapeutic proteins for immune-mediated inflammatory diseases / edited by Honghui Zhou, Diane R. Mould.

Disease Interception in Autoimmune Diseases: From a Conceptual Framework to Practical Implementation / Anish Suri -- The Role of Biomarkers in Treatment Algorithms for Ulcerative Colitis (UC) / Reena Khanna, Brian G Feagan -- Mechanism and Physiologically Based PK/PD Model in Assisting Translation from Preclinical to Clinical: Understanding PK/PD of Therapeutic Proteins at Site-of-Action / Xi Chen, Weirong Wang -- Application of Minimal Anticipated Biological Effect Level (MABEL) in Human Starting Dose Selection for Immunomodulatory Protein Therapeutics -- Principles and Case Studies / Haiqing Wang, Zheng Yang, Rong Shi -- Model-Based Meta-Analysis Use in the Development of Therapeutic Proteins / Timothy J Taylor, Bill Frame, Angela D Taylor -- Utility of Joint Population Exposure-Response Modeling Approach to Assess Multiple Continuous and Categorical Endpoints in Immunology Drug Development / Chuanpu Hu, Honghui Zhou -- Modeling Approaches to Characterize Target-Mediated Pharmacokinetics and Pharmacodynamics for Therapeutic Proteins / Leonid Gibiansky, Ekaterina Gibiansky -- Tutorial: Numerical (NONMEM) Implementation of the Target-Mediated Drug Disposition Model / Leonid Gibiansky, Ekaterina Gibiansky -- Translational Considerations in Developing Bispecific Antibodies: What Can We Learn from Quantitative Pharmacology? / Pradeep B Lukka, Santosh Wagh, Bernd Meibohm -- Application of Pharmacometrics and Systems Pharmacology to Current and Emerging Biologics in Inflammatory Bowel Diseases / Sihem Ait-Oudhia, Yi Ting (Kayla) Lien, Sumit Basu, Lawrence Lesko, Stephan Schmidt -- Pharmacokinetics-Based Dosing for Therapeutic Monoclonal Antibodies in Inflammatory Bowel Disease / Niels Vande Casteele, William J Sandborn -- Pharmacokinetics-Based Dosing Strategies for Therapeutic Proteins in Inflammatory Bowel Disease / Diane R Mould, Richard N Upton, Jessica Wojciechowski -- Quantitative Pharmacology Approach to Select Optimal Dose and Study the Important Factors in Determining Disposition of Therapeutic Monoclonal Antibody in Pediatric Subjects -- Some Considerations / Deni Hardiansyah, Chee M Ng -- Quantitative Pharmacology Assessment Strategy Therapeutic Proteins in Pediatric Subjects -- Challenges and Opportunities / Jeremiah D Momper, Andrew Mulberg, Nitin Mehrotra, Dan Turner, William Faubion, Laurie Conklin, Karim Azer, Marla C Dubinsky -- Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins for Plaque Psoriasis -- Guselkumab / Zhenling Yao, Yaowei Zhu, Chuanpu Hu, Yang Chen, Shu Li, Bruce Randazzo, Zhenhua Xu, Amarnath Sharma, Honghui Zhou -- Vedolizumab-A Case Example of Using Quantitative Pharmacology in Developing Therapeutic Biologics in Inflammatory Bowel Disease / Maria Rosario, Nathanael L Dirks, Diane R Mould, Catherine Scholz, Timothy Wyant, Asit Parikh, Irving Fox -- Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Systemic Lupus Erythematosus -- Belimumab / Herbert Struemper -- Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Multiple Sclerosis -- Peginterferon Beta-1a, Daclizumab Beta, Natalizumab / Xiao Hu, Yaming Hang, Lei Diao, Kumar K Muralidharan, Ivan Nestorov -- Index -- Supplemental Images.

Includes bibliographical references and index.

"Focused on quantitative pharmacology and individualized therapy for developing biotherapeutics in immune-mediated inflammatory diseases, this book discusses both theoretical and practical aspects and includes case studies illustrating applications in drug development. Provides frontline knowledge of using PK/PD modeling tools to address a variety of problems in development of therapeutic proteins. Reviews and discusses biomarkers, systems pharmacology, PBPK modeling, and target-mediated modeling, as translational tools. Helps readers understand disease progression and identify of mechanisms-based biomarkers with clinical relevance"--Provided by publisher.

Online resource; title from PDF title page (EBSCO, viewed February 25, 2019)