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Population Pharmacokinetics Of Therapeutic Monoclonal Antibodies: Examples And Estimation Method Performance Differences, Nathanael Le Dirks

Theses and Dissertations (ETD)

Over the past two decades, there has been an increase in the research and development and therapeutic application of monoclonal antibodies (mAbs). An application of pharmacokinetic (PK) and pharmacodynamic concepts that has likely contributed to the success of the pre-clinical and clinical drug development of therapeutic mAbs is population PK, which attempts to quantify the typical disposition characteristics and sources of PK variability (such as between-subject, within-subject, and inter-occasion variability) within study populations. Population PK also attempts to identify and quantify the impact of covariates on systemic drug exposure and assess their potential implications for clinical dosing. The general theme …