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Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report. Consequently, population pharmacokinetic and pharmacodynamic model-based approaches are often implemented to evaluate mAb drug interactions.Ībbas AK, Lichtman AH.
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Due to the pharmacokinetic properties of mAbs, interacting drugs may need to be administered for protracted periods. The evaluation of drug interactions requires innovative designs. The use of loading doses or dose adjustments to improve clinical response is also a consideration. Traditional approaches such as flat dosing and variable dosing based upon body surface area or weight should be supported by pharmacokinetic and pharmacodynamic behavior, including target antigen and concurrent disease states. Optimal dose selection should ensure uniform mAb exposure across all individuals. Various metrics are available for scaling from animals to humans. Species differences in pharmacology need to be considered. Selection of a starting dose for human studies can be difficult. This behavior provides challenges during clinical development studies must be carefully planned to account for complexities specific to each agent. mAb pharmacodynamics are often indirect, with delayed clinically relevant outcomes. Where nonlinear kinetics exist, clearance can change due to receptor loss following repeated dosing and/or disease severity. mAbs targeting soluble antigens often exhibit linear phar-macokinetic behavior, whereas mAbs targeting cell surface antigens frequently exhibit nonlinear behavior due to receptor-mediated clearance. Monoclonal antibodies (mAbs) have complex pharmacology pharmacokinetics and pharmacodynamics depend on mAb structure and target antigen.