Introducing 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.
Predictive modeling technology across the drug development cycle
Simcyp Biopharmaceutics is the latest addition to the Simcyp family of mechanistic and predictive modeling technologies. Complementing Simcyp Animal, Simcyp Discovery, and the Simcyp Simulator for physiologically based pharmacokinetic (PBPK) modeling, Simcyp Biopharmaceutics brings a new dimension to our suite of solutions.
Dive into the future of drug development with Simcyp Biopharmaceutics.
Experience Simcyp Biopharmaceutics’ efficient and cost-effective approach that adds value by refining complex drug formulations and elevating biowaiver success rates for novel and generic drugs.
Mastering Formulation Excellence with Simcyp Biopharmaceutics
Discover how to elevate your strategies, accelerate formulations, and gain insights from industry leaders to include special guest, Dr. Jennifer Dressman. This session is your gateway to the latest advancements in model-informed formulation development (MIFD) technology, brought to you by the trailblazers at Simcyp.
Simcyp quality. Expansive use cases. Affordably priced.
Features and Capabilities
Advanced GI Chemistry and Physiology
Virtual Bioequivalence Module
Modified Formulation Simulations
Mechanistic IVIVC. IVIVE
Simcyp In Vitro Analysis (SIVA) Toolbox
Primary Use Cases
Early Formulation Development
Manufacturing and Quality Control
Alternative Routes of Administration
Biowaver Submission Strategy
Product Lifecycle Management