Box 2.
Key questions, modelling strategies and possible outcomes for high-impact regulatory submissions: fg fraction escaping intestinal loss, Ki reversible inhibition constant, KI inhibitor concentration at half maximal inactivation, NCE as a victim of DDI. DDI drug–drug interaction, Qx Quarter x, NCE new chemical entity, SAD single ascending dose, MAD multiple ascending dose, PK pharmacokinetics, P-gp P-glycoprotein, OATP organic anion transporting polypeptide, OCT organic cation transporter, BCRP breast cancer resistance protein, EC50 half maximal effective concentration, Emax maximum effective concentration
