Simcyp™ PBPK 建模服务

The Simcyp PBPK services team leverages the Simcyp PBPK Simulator, the gold standard for predicting drug-drug interactions (DDI). They help clients predict DDI in early clinical development to inform inclusion/exclusion criteria, predict PK with combination drugs and achieve label claims in lieu of clinical trials. Whether straightforward or complex, our team has a proven track record of helping clients streamline their clinical pharmacology package reducing the reliance on costly DDI studies.

PBPK modeling can be used to define laboratory objectives, inform candidate selection and predict first-in-human (FIH) PK without the need for extensive in vivo testing. The Simcyp PBPK services team has extensive experience using Simcyp Discovery to predict human PK and efficacious dose in discovery and preclinical stages where limited data is available.  In addition, the team is concurrently understanding and mitigating potential formulation and DDI risks.

Children, older adults, pregnant women, and patients with impaired kidney or liver function are not typically included in clinical trials, resulting in a lack of prescribing instructions in the drug label. The Simcyp PBPK services team regularly uses the Simcyp PBPK Simulator to integrate intrinsic and extrinsic factors, data on the drug, the system and sub-population physiology to predict PK and dose differences in these under-represented populations. In many cases, these simulations are used in lieu of or to supplement available clinical data in these subject groups.

Model-informed formulation development (MIFD) is an iterative process that maps across the drug development paradigm.  Our Simcyp PBPK services team has a proven track record predicting formulation outcomes, forecasting food-drug interactions, developing in vitro-in vivo correlation (IVIVC), predicting virtual bioequivalence (VBE), justifying biowaivers, and more. These approaches have been applied across different BCS class drugs, reducing development costs and timelines. Simcyp enabled the first and only VBE for a complex generic drug.