Derivation of Evidence-Based Oral-to-Parenteral Uncertainty Factors for Medical Device Toxicological Risk Assessment

2026-05-08

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Bryant Moeller *

DOI：10.1016/j.yrtph.2026.106127

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• Estimated oral bioavailability for 7,697 medical device constituents using in silico PBPK modeling. • Demonstrated that the majority of medical device constituents exhibit moderate to high oral bioavailability, with nearly half exceeding 90%. • Derived an evidence-based default oral-to-parenteral uncertainty factor of 7, refining the historical ISO 10993-17 default of 10 while maintaining patient safety. • Showed that bioavailability estimates are available for approximately 42% of published medical device constituents, increasing opportunities for chemical-specific or analogue-based uncertainty factor refinement.

Keywords:

Oral bioavailability

Medical device constituents

PBPK modeling

Uncertainty factor

Toxicological risk assessment

Derivation of Evidence-Based Oral-to-Parenteral Uncertainty Factors for Medical Device Toxicological Risk Assessment

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