Pharmacokinetics and ADME characterizations of antibody-drug conjugates.

Pharmacokinetic and absorption, distribution, metabolism, and excretion (ADME) characterization of antibody-drug conjugates (ADCs) reflects the dynamic interactions between the biological system and ADC, and provides critical assessments in lead selection, optimization, and clinical development. Understanding the pharmacokinetics (PK), ADME properties and consequently the pharmacokinetic-pharmacodynamic properties of ADCs is critical for their successful development. This chapter discusses the PK properties of ADCs, types of PK and ADME studies in supporting different stages of development, general design of PK/ADME studies with a focus on ADC-specific characteristics, and interpretation of PK parameters.