PK/PD Modeling

PK/PD modeling has already been used extensively in pre-clinical and clinical drug development. However, few examples exist within the literature on the application of modeling to enable the appropriate engineering and testing of biological therapeutics. Benefits of PK/PD modeling for biologics include to elucidate biochemical process and mechanism of biologics action, to guide decision and selection of drug candidates for streamlining biologics development, and to optimize clinical dosing regimen. Five commonly applied models are presented for discussion.

Benefits of PK/PD modeling for biologics include elucidating biochemical process and mechanism of biologics action, to guide decision and selection of drug candidates for streamlining biologics development, and to optimize patient dosing regimen. Five models are presented, Direct link PK/PD model, Indirect link PK/PD model, direct response PK/PD model, Cell lifespan model, and Complex response model. Direct link model is illustrated with an anti-IgE antibody, assuming that the effect site is within the central compartment, and therefore no delay of pharmacological response occurs. For model assessment, Emax model is applied for continuous pharmacological response in direct link modeling.