The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody ...

This tutorial will review major drug disposition processes relevant for mAbs, and will highlight product‐specific and patient‐specific factors that modulate their pharmacokinetic (PK) behavior and need to be considered for successful clinical therapy. Structure and origin

The human PK of a mAb can be reasonably estimated using cynomolgus monkey data and allometric scaling methods. Keywords: Fc-fusion protein; FcRn; anti-drug antibody (ADA); glycosylation; human PK prediction; monoclonal antibody (mAb); pharmacokinetics; target-mediated drug disposition (TMDD).

The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug devel-opment. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision-making.

The pharmacokinetics (PK) of therapeutic antibodies is determined by target and non-target mediated mechanisms. These antibody-specific factors need to be considered during prediction of human PK based upon preclinical information.

Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision-making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early ...

Sep 1, 2016 · Monoclonal antibodies (mAbs) are an important therapeutic class with complex pharmacology and interdependent pharmacokinetic (PK) and pharmacodynamics (PD) properties.

Oct 16, 2024 · Antibody pharmacokinetics (PK) is the study of how the body interacts with antibodies after administration, particularly with absorption, distribution, metabolism, and excretion. It is essential in the drug development process, as it allows us to assess the antibody’s therapeutic efficacy and intensity.

anti-drug antibody response, and off-target binding. In this review article, general PK properties and the factors influencing the PK of mAbs and Fc fusion proteins will be discussed, in addition to PK topics related to preclinical and early clinical development of mAb drugs. The impacts of glycosylation on the PK and PD of mAbs

The linear pharmacokinetics (PK) of therapeutic monoclonal antibodies (mAbs) can be considered a class property with values that are similar to endogenous IgG. Knowledge of these parameters across species could be used to avoid unnecessary in vivo PK studies and to enable early PK predictions and ph …