2019 PharmSci 360
This is a retrospective analysis of oncology drug approvals by the FDA over the past 2 decades to identify hepatic impairment strategies utilized by sponsors to inform dosing recommendation of large molecule oncology drugs for patients with HI.
1. Identify HI strategies commonly utilized by sponsors to inform dosing recommendation of LMs for patients with HI
2. Understand the rationale why a specific HI strategy was utilized
3. Identify trends in regulatory expectations to assess HI effect on the PK of LMs