Titlebook: Development of Antibody-Based Therapeutics; Translational Consid Mohammad A. Tabrizi,Gadi G. Bornstein,Scott L. Kla Book 20121st edition Sp

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Biophysical Considerations for Development of Antibody-Based Therapeutics,–antigen complexes for drug candidate optimization and the design of clinical dosing strategies. For measuring the dissociation equilibrium constants of mAbs binding reversibly to antigens, two premier technologies are commonly used: Biacore surface plasmon resonance (SPR) and the solution-based kin

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Bioanalytical Considerations for Development of Antibody-Based Therapeutics: Pharmacokinetics and Ifor successful translation of information into the later phases of antibody development require the use of relevant bioanalytical (BA) methodologies from early preclinical stages. Here, we discuss a suite of BA methodologies that can be used to enable pharmacokinetics, immunogenicity, and biomarker

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Application of Pharmacokinetic/Pharmacodynamic Modeling in the Development of Antibody-Based Theraplved from a simple descriptive endeavor to an essential component of model-based drug development. The role of PK/PD modeling can be more critical for antibody-based therapeutics owing to their complex pharmacological properties. Nonlinear behavior can manifest in most of the physiological processes

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Application of Population Pharmacokinetic-Pharmacodynamic Approaches in the Design of Translational few decades. The development of antibody-based therapeutics has benefited substantially from the utilization of population approaches. Moreover, almost all FDA-approved monoclonal antibody therapeutics have been evaluated using population approaches. In this chapter, application of population PK-PD

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Translational Biomarkers: Essential Tools in Development of Antibody-Based Therapeutics,f relevant biomarkers can streamline this process significantly. Selecting and evaluating relevant biomarkers early on not only lessens the time and cost associated with clinical evaluation, but also fosters implementation of rational decision-making processes throughout various antibody development

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