Advances lead optimization, first-in-human dose prediction and formulation development
Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Discovery Simulator, a new software designed for scientists working in small molecule drug discovery and translational research. Derived from the industry-leading Simcyp Simulator, Simcyp Discovery increases confidence in early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling and simulation.
“We are pleased to offer our new Simcyp Discovery Simulator to help identify and move forward the most promising new drug candidates for further investigation,” said William F. Feehery, Ph.D., CEO of Certara. “The failure rate from preclinical to clinical studies is high with only a third of drugs entering into human testing. With Simcyp Discovery, scientists can apply PBPK earlier in the development process to better inform critical decisions and reduce risk of drug failure.”
Simcyp Discovery includes PBPK models for mouse, rat, dog, monkey and humans, enabling researchers to predict first-in-human (FIH) pharmacokinetics and understand how investigational drugs may behave before going into clinical trials, a regulatory requirement. The software also supports early formulation simulations and flags potential drug-drug interactions (DDI) with a new static DDI calculator informed by regulatory guidelines from the U.S. Food and Drug Administration, European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency. Additionally, Simcyp Discovery supports rapid batch processing and screening of drug candidates.
“The role of modeling and simulation in drug discovery and development continues to expand and evolve. At Certara, we are committed to advancing our technology to meet the needs of researchers throughout the entire drug lifecycle,” said Robert Aspbury, Ph.D., president of Simcyp at Certara. “Simcyp Discovery will help improve translational research and impact patient safety and efficacy.”
For more information about Simcyp Discovery, please visit: https://www.certara.com/simcyp-overview/simcyp-discovery/
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.