Figure 2.

PBPK modeling within a Predict‐Learn‐Confirm‐Apply framework. High‐fidelity PBPK models for buprenorphine and voxelotor were informed by quantitative understanding of clearance mechanisms from the human MB (mass balance) study. The final models were used to assess the exposure of buprenorphine in neonates with NAS (neonatal abstinence syndrome) and investigate DDIs (drug–drug interactions) in patients with SCD (sickle cell disease), respectively. CYP, cytochrome P450; IV, intravenous; SL, sublingual; UGT, uridine diphosphate (UDP)‐glucuronosyltransferase.