AI in bioequivalence.
AI is operational at the bioanalytical and pre-study end of BE; supportive at the modelling end (PBPK); and not yet acceptable as primary registration evidence. Inspection risk varies sharply by use case.
AI in bioequivalence.
Where AI is changing things now & 2026–2030AI is operational at the bioanalytical and pre-study end of BE; supportive at the modelling end (PBPK); and not yet acceptable as primary registration evidence. Inspection risk varies sharply by use case — site selection low, model-based biowaiver justification high.
Cohort enrichment & site selection.
Replaces manual site screening; augments volunteer-pool matching to inclusion criteria. Standard 2024+ via Medidata, ICON, Syneos platforms. Not yet explicitly covered in BE guidance. Inspection risk low — data selection, not data generation.
PBPK model qualification for biowaiver.
Augments BCS biowaiver justification with mechanistic evidence. FDA 2024 MIDD guidance permits as supportive; EMA cautious. Model qualification standards unspecified — the regulatory boundary is unclear. Risk high if a model fails post-approval.
Bioanalytical peak detection.
Replaces manual chromatogram review; augments operator variability reduction. Standard in LC-MS/MS instruments (Sciex, Waters, Thermo). Already under ICH M10 v2 scope discussion.
Pop-PK parameter estimation.
Augments BE analysis supporting long-acting injectables and population studies. Established via NONMEM, Monolix, Phoenix. ICH E9 statistical guidance framework, not BE-specific. No AI-specific friction.
RWE curation for synthetic controls.
Augments external control arm selection for synthetic BE studies. Pilot stage (FDA-led, EMA cautious). No formal BE-specific framework. Medium risk — data quality and representativeness contested.
AI formulation optimisation.
Augments excipient selection and release-mechanism design for modified-release. Research-stage; not yet operational in registration submissions. Considered a formulation development tool, not registration-quality. Low risk for 2026–2030.