A very comprehensive IND-enabling ADME package to support filing an IND contains data from the following studies:

►Bioanalytical method validation in two or more species, typically one rodent and one or more non-rodent species
►Single dose pharmacokinetics, dose proportionality and absolute bioavailability in one rodent and one or more non-rodent species
►Multiple dose pharmacokinetics in one rodent and one non-rodent species
►Plasma protein binding in one rodent, one or more non-rodent species, and human
►Tissue distribution by Quantitative Whole-Body Autoradiography (QWBA)
►in vitro metabolism in animal and human hepatic preparations
►in vitro CYP450 inhibition in human liver microsomes
►ex vivo CYP450 induction in liver microsomes from animal safety studies
►in vitro reaction phenotyping in human liver microsomes using both chemical inhibitors and cDNA by monitoring disappearance of the parent drug
►Mass balance and routes of excretion in rodent and possibly non-rodent species
►Metabolite profiling and identification in rodent and possibly non-rodent species.