# OnCo record idea-tr1-pk-informed-organ-thresholds (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-pk-informed-organ-thresholds/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-tr1-pk-informed-organ-thresholds" ;
  schema:name "Replace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds"@en ;
  schema:description "Most trials copy the same kidney and liver cut-offs, such as creatinine clearance above 60, regardless of how the drug is cleared. Setting each threshold from the drug's own clearance route and organ-impairment pharmacokinetic studies would let patients with mild organ impairment join safely instead of being excluded."@en ;
  schema:url <https://onco.cc/ideas/idea-tr1-pk-informed-organ-thresholds/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-organ-dysfunction-or-prior-or-concurrent> ;
  onco:cancers <https://onco.cc/cancers/multiple-myeloma/>, <https://onco.cc/cancers/urothelial/>, <https://onco.cc/cancers/rcc/> ;
  onco:technologies <https://onco.cc/technologies/monoclonal-antibody/>, <https://onco.cc/technologies/adc/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-enrolment/>, <https://onco.cc/bottlenecks/b-dose-optimisation/>, <https://onco.cc/bottlenecks/b-aging-comorbidity/> .