Anticipate, quantify, and explain interaction risk — before the trial.
Modeling & simulation (PK/PD, PBPK, popPK) help you prioritize DDI studies, justify clinical scenarios, and secure recommendations (labeling, dose adjustments, contraindications).
Applications of modeling: which approaches for DDIs
Data-driven analyses to prioritize studies and support clear recommendations.
DDI “perpetrator” (inhibition/induction)
Predict the impact on substrate exposure (AUC, Cmax), frame scenarios, and define the need for clinical studies.
DDI “victim” (candidate sensitivity)
Quantify sensitivity to inhibitors/inducers, identify worst-case scenarios, and pinpoint critical co-medications.
Recommandations & label
Translate results into defensible recommendations: dose adjustments, dosing windows, contraindications.
PBPK & “what-if” scenarios
Explore enzymes/transporters, polymorphisms, organ impairment, multiple perpetrators, and extrapolations.
PopPK / integrated modeling
Leverage clinical data (sparse/dense), covariates, real-world co-medications, and interindividual variability.
Study design & prioritization
Selection of substrates/inhibitors/inducers, doses, dosing windows, washout, and power — for an efficient DDI plan.
A DDI strategy aligned with data, mechanisms, and regulatory expectations
From rapid triage to a full PBPK model — with deliverables ready for clinical and regulatory use.
Mechanistic interpretation
Enzyme/transporter hypotheses, in vitro/in vivo parameters, uncertainties, and a model qualification plan.
Scientific evidence strategy
What level of evidence is needed for each decision: extrapolation, dedicated study, or opportunistic analysis.
Submission-ready deliverables
Reports, appendices, and justification materials to support agency interactions and regulatory dossiers (protocols, SAPs, CSRs).
Case study #1
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Case study #2
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Case study #3
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Share your DDI context: mechanism, data, and the decision to be secured
We get back to you with a clear strategy, defined timelines, and tailored deliverables (triage → model → recommendations).