Abstract
A science-based approach for translation of exposure–response data is vital for effective advancement of antibody-based therapeutics. A critical consideration during the development of antibody-based therapeutics is selection and evaluation of relevant biomarkers during early preclinical stages. Effective application of biomarkers not only lessens the time and cost associated with the drug development process, but also fosters implementation of rational development progress throughout various development phases. When appropriate immunoassay methodologies are available, relationships between antibody pharmacokinetics (PK) and ensuing effects on biomarkers can be effectively examined. Evaluation of exposure–response relationships in vivo can provide invaluable information with respect to antibody potency and pharmacodynamic response efficiency.
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Azadi, G., Ayanoglu, G., Ganti, V., Shankaran, H., Tabrizi, M.A. (2018). Application of Proof-of-Mechanism Biomarkers (POM) in Design and Development of Biologics Modalities. In: Tabrizi, M., Bornstein, G., Klakamp, S. (eds) Development of Antibody-Based Therapeutics. Adis, Singapore. https://doi.org/10.1007/978-981-13-0496-5_9
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DOI: https://doi.org/10.1007/978-981-13-0496-5_9
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