Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Simulator Version 21, which updates the Company’s population-based modeling and simulation platform. The Simcyp Simulator is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions.
Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator models describe the behavior of drugs in different body tissues and include genetic, physiological and epidemiological databases that facilitate simulations in virtual populations. The Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drug approvals by the US Food and Drug Administration (FDA). These were achieved virtually, using PBPK modeling and simulation in lieu of performing clinical trials.
“We are excited to offer new capabilities to advance modern drug development with the launch of our latest Simcyp Simulator,” said William F. Feehery, Ph.D., CEO of Certara. “Certara’s Simcyp Simulator and modeling expertise have already supported more than 850 peer-reviewed scientific publications, demonstrating its significant impact in drug development. This latest update aligns with recent regulatory guidances, so that we can help accelerate the development and approval of crucial therapies to patients.”
New capabilities of the Simcyp Simulator include:
“The application of Simcyp modeling continues to grow in formulation development, drug-drug interactions and special populations for novel drugs,” said Masoud Jamei, Ph.D., senior vice president of Simcyp research and development at Certara. “We’re proud to further support the development of advanced medicines by providing to our industry, academic and regulatory partners the latest innovations in biosimulation to efficiently and ethically evaluate drug performance, dosing regimens and drug interactions and help bring safer and more effective therapeutics to all patients.”
Version 21 also features updates to Simcyp modules for pediatrics, pregnancy, lactation, biologic drugs, virtual bioequivalence and in vitro-in vivo correlation.
About Certara
Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.
Certara Contact
Jieun W. Choe
This email address is being protected from spambots. You need JavaScript enabled to view it.
Media Contacts:
Daniel Yunger
Kekst CNC
This email address is being protected from spambots. You need JavaScript enabled to view it.
Ariane Lovell
Finn Partners
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investor Relations Contact:
David Deuchler
Gilmartin Group
This email address is being protected from spambots. You need JavaScript enabled to view it.
Last Trade: | US$16.73 |
Daily Change: | 0.20 1.21 |
Daily Volume: | 372,468 |
Market Cap: | US$2.690B |
May 07, 2024 April 16, 2024 February 29, 2024 December 13, 2023 November 21, 2023 |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
CLICK TO LEARN MORECue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
CLICK TO LEARN MOREEnd of content
No more pages to load
COPYRIGHT ©2023 HEALTH STOCKS HUB