Updates advance the mission of the FDA’s new Quantitative Medicine Center of Excellence, which seeks to leverage biosimulation for therapeutic medical product development and inform regulatory decision-making.
RADNOR, PA — 2024 年 6 月 3 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development, has released a new version of the Simcyp™ Simulator for physiologically based pharmacokinetic (PBPK) modeling. The latest version includes numerous advancements for Simcyp Simulator clients which utilize the simulator to support data driven decision making at every stage of development.
The release of Simcyp Simulator Version 23 coincides with the recent announcement of the FDA establishing the new Quantitative Medicine (QM) Center of Excellence (CoE) within the Center for Drug for Drug Evaluation and Research (CDER). The center will facilitate the application of quantitative modeling and simulation to drug development, regulatory decision-making, and patient care. PBPK is cornerstone of these quantitative methods, enabling better predictions of tissue-by-tissue pharmacokinetics based on biological data from nonclinical and clinical sources.
“The adoption of biosimulation, particularly PBPK, continues to gain regulatory acceptance,” Rob Aspbury, President Certara Predictive Technologies said. “We continue to collaborate with our clients and consortium members to advance the Simcyp Simulator to deliver greater value to scientists supporting better decision-making through in-silico modeling and virtual trials that de-risk development and bring medicines to patients faster.”
Development of the Simcyp Simulator is guided by a consortium of 35 leading pharmaceutical companies. Version 23 incorporates their feedback, which drives valuable enhancements and the expansion of existing capabilities. Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara added, “Our aim with Version 23 was to significantly enhance our predictive modeling technology and to further integrate the cutting-edge science with regulatory standards.”
This release introduces advancements in four pivotal areas:
- Regulatory Best Practices: Version 23 aligns with recent FDA guidelines for industry to facilitate smoother regulatory approvals.
- Innovative DDI Prediction: The new version uses advanced biomarker modeling for predicting DDI risks.
- Increased Biologics Support: Version 23 can predict drug disposition of emerging therapeutic modalities such as oligonucleotides.
- Expanded Biopharmaceutics Capabilities: Version 23 enables evaluating virtual bioequivalence for oral, dermal, and inhaled formulations.
The Simcyp Simulator has contributed to over 110 FDA-approved novel drugs, informed more than 350 drug label claims and supported clinical trial waivers in many areas.
For more insights into the latest developments, visit the Simcyp Simulator webpage or watch the release webinar ⬇️
About Certara: Certara 利用生物模拟软件、技术和服务加速药物研发，从而改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 66 个国家的监管机构。了解更多信息，请访问 www.certara.com.cn。
