PRINCETON, NJ, Nov. 21, 2023 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the launch of Simcyp™ Biopharmaceutics software. It is designed for use by biopharmaceutical, formulation and CMC scientists to assist in the rapid and cost-effective formulation of complex new and generic small molecule drugs. Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved new therapies.
“The Simcyp Simulator is widely known for its applications in clinical development, including predicting drug interactions, drug-food interactions, and drug performance in populations such as pediatrics and organ dysfunction,” said Rob Aspbury, president of Certara Scientific Software. “To further meet customer requests and regulatory needs at earlier stages of drug development, we have invested in advanced scientific formulation modeling technology over the past five years and participated in the US FDA R&D grant programs in this area .”
Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to obtain biowaivers that are used in lieu of conducting clinical trials. It is available as a standalone product and is designed for life sciences companies of all sizes looking to optimize the formulations of their therapies to maximize safety, efficacy and patient convenience.
Simcyp Biopharmaceutics software delivers value and unique capabilities in several areas critical to achieving formulation success, including:
- Replace expensive clinical bioequivalence studies – With increasing encouragement from regulators, virtual bioequivalence (VBE) studies use physiologically based pharmacokinetic (PBPK) modeling to demonstrate bioequivalence (BE) between test and reference drugs. The Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design, significantly increasing the potential for obtaining biowaivers.
- Optimize formulation for complex drugs: Biopharmaceutical Classification System (BCS) Class II-IV drugs are challenging to prepare for oral formulations due to their poor solubility and/or absorption. Simcyp Biopharmaceutics software facilitates the development of these drugs, which represent 90% of new drug candidates.
- Inform drug labels – Recent FDA guidance recognizes physiologically based pharmacokinetic (PBPK) modeling as a valuable technology for identifying and optimizing the impact of gastrointestinal effects such as meal type and pH. Simcyp Biopharmaceutics software enhances these capabilities to optimize dosing strategies and provide label guidance to physicians.
For more information about the Simcyp Biopharmaceutics software, visit our website.
Certara accelerates drug discovery using biosimulation software, technology and services to transform traditional drug discovery and development. Its customers include more than 2,300 biopharmaceutical companies, academic institutions and regulatory agencies in 70 countries. More information at Certara.com.
Certara contact person:
Contact person for Investor Relations: