eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation

One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued

Simcyp Discovery Simulator

Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers confidence in decision-making during the pre-Investigational New Drug (IND) application and translational development. Simcyp Discovery is based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, a regulatory-adopted, versatile tool in drug development that helps answer a myriad of “what if” questions … Continued

Certara Awarded FDA Grant to Further Advance Virtual Bioequivalence Assessments of Generic Medicines Using Biosimulation

Represents Fourth FDA Grant for Simcyp MechDermA Model for Virtual Bioequivalence PRINCETON, N.J.— September 20, 2021. Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded a grant from the U.S. Food and Drug Administration (FDA) to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) to help enable … Continued

Essentials of Model-informed Drug Development (MIDD) – Top-down vs. Bottom-up Approaches

How can the latest modeling and simulation technologies accelerate drug discovery and development? We frequently receive questions about why model-informed drug development (MIDD) is so critical to informing the development of safer and more effective new drugs? Indeed, all drug discovery and development today involves some level of MIDD, a term that encompasses a large … Continued

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD). Guanfacine is primarily metabolized by the CYP3A4 enzyme. Thus, it was important to evaluate the drug-drug interaction (DDI) liability perpetrated by strong inhibitors and inducers of CYP3A4. Using data from … Continued

Certara’s Simcyp™ COVID-19 Vaccine Model Named Finalist in Both the 2021 Citeline Awards and R&D 100 Awards

PRINCETON, NJ – August 26, 2021 – Certara, a global leader in biosimulation, today announced that its Simcyp COVID-19 Vaccine Model has been named a finalist in both Informa Pharma Intelligence’s 2021 Citeline Awards in the Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities category and R&D World’s 2021 R&D 100 Awards … Continued

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