ABSTRACT
Antibody drugs have experienced development for nearly 30 years. There are varieties of therapeutic antibody drugs successfully used in clinical practice. The design of pre-clinical and clinical pharmacokinetic studies for antibody drugs has achieved some progress. This article analyzed the issues in the pharmacokinetic studies of therapeutic antibody drugs from four aspects, including challenges for pharmacokinetic studies, pharmacokinetic characteristics, pharmacokinetic-pharmacodynamic research and some examples of pharmacokinetic studies. As for the prospects for future development, one of challenges is the establishment of bio-analytical methods, which ensure the reliability of the basic findings. Another challenge is the PK and PK/PD analysis. For antibody drugs displaying obvious targeting ability, target distribution is the key point of their pharmacokinetic studies. PK/PD model for data analysis, exposure-response assessment, and release of targeted drug delivery face more prominent challenges.