Simcyp™ Biopharmaceutics

Simcyp Biopharmaceutics is a small-molecule human PBPK platform with built-in capabilities for simulating healthy volunteer populations, the most commonly used subjects in clinical pharmacology studies.

The platform supports biologically realistic simulation of gastrointestinal drug absorption using both the Advanced Dissolution and Metabolism Absorption (ADAM) Model (ADAM) and multi-layered ADAM (M-ADAM) models. The base product also supports intravenous administration, and other routes such as subcutaneous, intra-muscular, rectal, and vaginal may also be accommodated through supplemental modules. Given the pivotal role of in vitro data in the model-informed formulation development (MIFD) approach, Simcyp Biopharmaceutics includes both mechanistic in vitro-in vivo correlation (IVIVC) and the SIVA toolbox. Likewise, Simcyp’s VBE module, an add-on for the main simulator, is included with Simcyp Biopharmaceutics.

Simcyp Biopharmaceutics streamlines the identification and refinement of promising formulations in a cost-effective manner. It offers tailored support for formulation strategies in the dynamic landscape of complex novel and generic drugs. Simcyp Biopharmaceutics enhances the achievement of successful biowaivers, ultimately bolstering overall success rates. It features forward compatibility with the Simcyp Simulator for seamless facilitation across the drug development cycle.