Analysis of trends in physiologically based pharmacokinetic modelling in silico in translational studies of monoclonal antibodies

Background.Monoclonal antibodies (mABs) and their fragments are widely used for therapeutic, diagnostic, research and other purposes.At the same time, the de ve lop ment of this group of pharmacotherapeutic agents still encounters a number of challenges.One of the areas of improvement in translational (T) studies is the use of pharmacometrics in silico, which can be explained by significant progress in the computing facilities, increased data volume and information availability.Aim.The aim of the study was to identify trends and directions of using physiologically based pharmacokinetic modelling (PBPK) in silico in translational studies of mABs.Methods.The analysis of scientific publications of the PubMed database for the period up to May 2024 inclusive was used.The keywords used in the advanced search were combinations of the words "PBPK" and "mAB", "antibody", "antibody drug conjugate", and combinations of "PBPK" with drugs (mABs) that fit our scope.Results.In total, 129 scientific articles were identified according to the selected criteria, including 110 (85%) original and 19 (15%) review articles.Although the first paper was published in 1994, 90% (116 publications) were published in the last 10 years (2013-May 2024), including 61% (79) in the last 5 years (2019-May 2024).Over the past 5 years, more than two thirds of original publications were related to the basic (T0) and preclinical (T1) stages of translational studies.43% of the papers were devoted to the study of parameters that may affect the absorption, distribution, metabolism and excre tion (ADME) of mABs, including physicochemical char