In Vitro Studies:
◆ Blood-to-plasma ratio
◆ Plasma protein binding assay
◆ Plasma stability assay
◆ Microsomal metabolic assay in liver
◆ Hepatocyte metabolic stability assay
◆ CYP450 inhibition assay
◆ CYP450 induction assay
◆ Metabolic phenotyping
◆ Metabolite identification
◆ Transporter analysis (substrates and inhibitors)
◆ Caco-2 cell monolayer permeability assay
In Vivo Studies:
◆ Plasma kinetic study
◆ Tissue distribution study
◆ Excretion study
◆ Mass balance assessment (including radioisotopes)
◆ Metal element analysis
◆ Blood-brain barrier
◆ ADC pharmacokinetic evaluation
◆ Receptor occupancy assay
