Given the complex structure of ADCs, which contain both large and small molecule components, and the mixture of various DAR species in the dosing solution, the PK of ADCs are expected to be complex1, at least three different analytes are commonly required to characterize the PK properties of an ADC: antibody-drug conjugated, total antibody, and unconjugated payload. Pharmacokinetic (PK) study is necessary for drug discovery and development process to help understand and predict the behavior of drugs and to link with the pharmacodynamics or toxicological effects of drugs. |