TABLE 2

Types of in vitro and in vivo studies for characterization of ADC ADME

Molecule	ADME Data
ADC^{^a}	In vitro stability in plasma or serum from animals and humans
ADC^{^a}	PK in pharmacology and toxicology species
ADC^{^b}	Animal (rodent) ADME: PK, excretion, and metabolism
ADC	Identification of circulating metabolites formed from the released drug in patients
Drug	Rodent PK
Drug	Plasma protein binding across species
Drug	In vitro characterization of metabolites formed from the released drug (safety species and human)
Drug	Reaction phenotyping
Drug	Passive/active (uptake or efflux) transport (as substrate)
Drug	P450 inhibition and induction

↵^a Analytes that could be measured as appropriate include Tab, ADC, and unconjugated drug.
↵^b This evaluation is recommended to be conducted with an ADC bearing a radiolabel on the drug.