Topic: Drug-Drug Interaction and Organ-Impairment Strategy

Translating Kidney Function Into Exposure Predictions

Transporter DDI Through Uptake and Efflux Pathways

Time-Dependent Inhibition, Induction, and Recovery

Selecting Clinical DDI Studies and Probe Substrates

Renal Clearance Mechanisms Beyond Glomerular Filtration

Quantifying DDI Effects in Organ-Impaired Patients

Mechanistic Decomposition of Hepatic Impairment Effects

Justifying DDI Study Waivers and Mechanistic Extrapolation

Integrated DDI and Organ-Impairment Decision Workshop

Interpreting Hepatic Impairment Pharmacokinetic Studies