Certara, the global leader in model-informed drug development and regulatory science, has launched version 17 of its Simcyp Population-based Simulator.
“We are proud to introduce several significant advances in Simcyp Simulator v17, including new in silico cancer patient and premature baby populations, enhanced skin and gut transporter models, and additional compound qualification summaries. These enhancements will further improve drug development decision making and expedite regulatory submissions,” said Stephen Toon, BPharm, PhD, president and managing director of Certara’s Simcyp division. “It is a testament to our strong partnership with the Simcyp Consortium – 36 leading biopharmaceutical member companies, and numerous global regulatory agency and academic center affiliates – that we continue to make these major strides forward.”
Certara’s Simcyp Simulator is the most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions (DDIs) and pharmacokinetic (PK) outcomes in clinical populations. These include vulnerable populations such as paediatric patients, pregnant women, and patients with impaired organ function.
The Simcyp Simulator links in vitro data to in vivo absorption, distribution, metabolism, and excretion (ADME) data and pharmacokinetic/pharmacodynamic (PK/PD) outcomes, allowing potential clinical issues to be explored prior to human studies. It provides crucial support for drug development decisions and is frequently used to inform drug labels.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes.