Simulations Plus

FDA is open to proposals of using modeling approaches for bioequivalence (BE), or for new drugs,with the proper justification and model verification

Numbers of applications (NDA, ANDA) supported by PBPK modeling has increased significantly since 2008.

Multiple species: human, rat, mouse, and dog, Population variability, The three primary acinar zones of liver represented, Essential cellular processes represented to multiple scales in interacting submodels...

DILI typically has drug-specific “signatures”: Hepatocellular, cholestatic, mixed (R-value), Latency “window,” Rate of progression, rate of resolution, Extra-hepatic manifestations (e.g. hypersensitivity signs)

Part I “You Must Unlearn What You Have Learned”: Clearing Up Myths About Aqueous Ionization of Drugs

Metabolite Assignment Considerations & Caveats: One compound can (and often does) give rise to two or more mass spectral (MS) peaks - but there should only be one HPLC peak per compound...

Antimalarial Drug Development 

Cooperation grant with the FDA (2014‐2019) a 4‐year funded collaborative project with the FDA  Office of Generic Drugs on the development of  mechanistic models for ocular delivery

Proprietary modeling platforms are driving the vast majority of internal R&D activities at companies.

DILIsym is a mechanistic, mathematical model that has been constructed to support pharmaceutical risk assessment and decision making

Applying IS-IV-IVE Techniques to Predict Exposure and Guide Risk Assessment

Simulations Plus continues to lead in the areas of PBPK modeling to support regulatory submissions and alternatives to animal testing.

So how can DILIsym help my organization? Predict DILI liabilities beforehand and save $$$, Choose the lead candidate most likely to succeed from a DILI standpoint, Communicate with regulators on safety issues with information they have requested from others numerous times and from a platform they license (FDA) & keep patients safer.

Identifying Right Target, Right Drug, Right Dose and Right Patient

DILIsym is a mechanistic, mathematical model that has been constructed to support pharmaceutical risk assessment and decision making.

Quantitative Systems Toxicology (QST) modeling can explain and predict species differences in dose-dependent hepatotoxicity.

DILIsym Is Used to Predict Bile-Acid Mediated Drug-Induced Liver Injury

HTPK lightens the burden of collecting and preparing input variables for full blown PK simulations by using structure-based predictions.

PBPK models allow incorporating different types of in vitro measurements into single platform to account for all processes affecting drug’s absorption, distribution and elimination.