Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
PRINCETON, NJ – 2020 年 4 月 29 日 – Certara®, the global leader in model-informed drug development announced today the launch of version 19 of its Simcyp® Population-based Simulator. Version 19 introduces new features to support safer and more efficient clinical studies, including models for testing drugs on pregnant women, enhanced drug formulation, and assessment of topical and transdermal drug products.
The Simcyp Simulator streamlines drug development through the modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) in virtual patient populations. The Simcyp Consortium of leading pharmaceutical and biotechnology companies meet to discuss the latest scientific developments in the area of modeling and simulation and guide the future development of the Simcyp Simulator. Over the past several years, it has helped expedite drug development and labeling for more than 65 novel U.S. Food and Drug Administration (FDA)-approved drugs.
“It is with great pride that we deliver Simcyp version 19 to our users, who represent more than 35 of the largest biopharma organizations in the world,” said William F. Feehery, PhD, Certara’s chief executive officer. “Our simulator enables these companies to optimize research and trial design so that they can deliver new drugs and biologics quickly and safely to patients in need.”
The simulator is a physiologically-based pharmacokinetic (PBPK) platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating and advancing new drug formulations, and predicting drug-drug interactions and PK outcomes in numerous virtual clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function. As the leading PBPK platform, the Simcyp Simulator is also currently being used to conduct virtual studies and predict exposure of candidate therapeutics for COVID-19.
“The Simcyp Simulator continues to advance modern drug development,” said Rob Aspbury, PhD, Simcyp’s president and managing director. “Version 19 provides new capabilities that help solve some of the biggest challenges facing drug development today, including testing drugs in complex patient populations, such as pregnant women and improving drug delivery and drug formulation.”
Simcyp Simulator v19 advances include the following:
Pregnancy-Fetal Risk Assessment
Version 19 of the simulator expands on the previous computer model for testing new drugs on pregnant women virtually, allowing users to assess drug disposition in the placenta and fetus after maternal drug intake. The Simcyp Simulator simulates fetal exposure to drugs and possible toxicity to the unborn child.
Biopharmaceutical Classification System (BCS) Class II and IV Drug Development
Working under a grant from the U.S. FDA, Certara has created a model for handling salt formulations to improve solubility and bioavailability, thereby optimizing the drug formulation for BCS Class II (low solubility, high permeability) and IV (low solubility, low permeability) compounds, which compose the majority of all compounds in development.
Dermal Drug Development
Version 19 provides an empirical drug precipitation model for the Simcyp Simulator’s MechDermA™ model that enables modeling of the metamorphosis of topical formulations following their application on the skin surface. The MechDermA model was recently used to support the first FDA virtual bioequivalence drug approval for a complex generic dermal drug1 and for expediting and expanding labeling for a novel retinoid molecule for the topical treatment of acne.2
PBPK Compound Models
Five new PBPK compound models, including crizotinib and rifabutin, and 25 updated compound models were added to the Simcyp Simulator, bringing the total number of models to 80 and allowing users to address a wider range of clinical studies and formulations.
Masoud Jamei, PhD, Simcyp’s senior vice president of research and development, added, “The launch of version 19 of the Simcyp Simulator reflects our ongoing commitment to innovation with advanced analytical tools such as Quasi Random Parametric Expectation – Maximization (QRPEM) algorithm and Global Sensitivity analysis such as Morris and extended Sobol to PBPK models.”
For more information on the Simcyp Simulator, please visit www.certara.com/simcyp-simulator.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国 FDA が承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
Jieun Choe 609-716-7939
Chief Strategy and Marketing Officer
Ariane Sloan 646-307-6317
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