Antisense oligonucleotide (ASO) therapeutics present new opportunities for treating challenging-to-treat diseases. Prediction of concentration–time course in systemic circulation and tissues within the context of large molecule physiologically based pharmacokinetic (PBPK) modelling has proven to be useful in animal-to-human extrapolation and first-in-human dose selection. A human PBPK model was developed and verified using bep...

Bevacizumab is a humanized monoclonal antibody (mAb) approved to treat various cancers in adults and was investigated in pediatric patients. While the drug development of small molecules in pediatrics has greatly benefited from the use of physiologically-based pharmacokinetic (PBPK) modeling for pharmacokinetic (PK) extrapolation, such application remains relatively limited in mAbs. In this study, our objective was to evaluate...