# OnCo record idea-tr1-organ-impairment-pk-before-approval (idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/ideas/idea-tr1-organ-impairment-pk-before-approval/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-tr1-organ-impairment-pk-before-approval" ;
  schema:name "Kidney and liver impairment dosing studies completed before approval, not years after"@en ;
  schema:description "Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one."@en ;
  schema:url <https://onco.cc/ideas/idea-tr1-organ-impairment-pk-before-approval/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus> ;
  onco:cancers <https://onco.cc/cancers/multiple-myeloma/>, <https://onco.cc/cancers/rcc/>, <https://onco.cc/cancers/hcc/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-dose-optimisation/>, <https://onco.cc/bottlenecks/b-aging-comorbidity/>, <https://onco.cc/bottlenecks/b-trial-enrolment/> .