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Optimize your development with our Modeling & Simulation expertise!
Are you wondering how pharmacometric Modeling and Simulation approaches can address your drug development challenges?
Samia Ezzine, D.Pharm; M.Sc; Ph.D — Chief Scientific Officer & PK/PD Expert
You working on:
- A specific route of administration,
- A complex distribution,
- A pediatric indication,
- A pro-drug,
- Identification of active metabolites,
- NHP (Non Human Primates) models,
- Special populations,
- A repositioning strategy...
Our experts are ready to support you
Our highly qualified experts are available to provide their expertise and advise you on a wide range of pharmacometric topics.
- Consolidate the choice of “FiH dose” and dose ranging in a phase I/II clinical trial
- Develop your candidate from the physico-chemical characterization & in vitro test (possibility of reaching an exposure threshold in humans)
- Predict the Pharmacokinetic of the candidate with different doses and dosing regimens
- Determine the best trade-off between the number of samples and the cost
- Predict the risk of QTc prolongation
- Identify the dose ranges to be used for in vivo studies
- Evaluate “in silico” drug–drug interactions to de-risk as early as preclinical development, and potentially a “biowaiver” in the clinic
- Reduce the number of clinical trials
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