You searched for fda

The Best Biosimulation Software, Technology & Services Blogs of 2022

We are grateful for all our loyal blog readers. Can you believe that it’s been eight years since we started blogging about our challenges and accomplishments in model-informed drug development, scientific informatics, regulatory science, and market access? Before plunging headfirst into 2023, we wanted to stop, reflect, and share our 2022 highlights with you in … Continued

https://www.certara.com/the-best-biosimulation-software-technology-services-blogs-of-2022/

Will the Inflation Reduction Act Impact Drug Development Decisions?

The short answer is yes. In fact, passage of the Inflation Reduction Act (H.R. 5376) has already impacted at least one company’s drug development plans based on a recent press release by Alnylam. On October 27th, Alnylam announced that “At this time, it will not initiate a Phase 3 study of vutrisiran in Stargardt Disease … Continued

https://www.certara.com/blog/will-the-inflation-reduction-act-impact-drug-development-decisions/

Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label

Physiologically based pharmacokinetic (PBPK) modeling and simulation has become an established approach to assess drug-drug interaction (DDI) liabilities involving CYP enzymes, with transporters and/or absorption-related mechanisms evolving in its acceptance by regulators. In addition, the use of PBPK modeling in specific populations such as organ impairment populations has been recently highly encouraged by the US … Continued

https://www.certara.com/webinar/physiologically-based-pharmacokinetic-modeling-simulation-to-support-asciminib-nda-submission-inform-drug-product-label/

Clinical Pharmacology & Pharmacometrics Should Collaborate to Implement Model-Informed Drug Development

Symbiosis between a modeler and a trialist is often required to develop a model-informed drug development strategy. This is because modelers can design an experiment the right way and allow for the results to be interpreted in a more integrative fashion. The modeler often views the totality of the data from multiple lines of investigation … Continued

https://www.certara.com/blog/clinical-pharmacology-pharmacometrics-should-collaborate-to-implement-model-informed-drug-development/

Ghent University wins the 2021/22 Certara-Simcyp Grant and Partnership Scheme

PRINCETON, N.J., January 9, 2023 — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Ghent University (Belgium) submitted the successful bid for the 2021/22 Grant and Partnership Scheme (GPS). Funding will now be provided for a two-year Postdoctoral Fellowship research project titled ‘Optimisation of therapy in patients with chronic kidney disease: … Continued

https://www.certara.com/announcement/ghent-university-wins-the-2021-22-certara-simcyp-grant-and-partnership-scheme/

New FDA Requirement to Support Labeling on DDIs in the Pediatric Population

The effects of drug-drug interactions (DDIs) could differ in the pediatric population compared to adults. The resulting changes in exposure of the victim drug, because of a DDI, at a metabolism and/or transport level could be larger or smaller, depending on the relative contribution of the affected enzyme/transporter to the disposition of the drug in … Continued

https://www.certara.com/blog/new-fda-requirement-to-support-labeling-on-ddis-in-the-pediatric-population/

Simcyp-led Linked-in Live Event Draws Hundreds of Registrants

Simcyp led a panel discussion on the benefits of using physiologically-based pharmacokinetic modeling & simulation for 2 vulnerable populations—pregnancy and pediatrics.

https://www.certara.com/announcement/simcyp-led-linked-in-live-event-draws-hundreds-of-registrants/

Axendia Industry Brief: FDA’s Digital Transformation Journey

A Roadmap to the Agency’s Modernization Action Plans “We’re not talking about PDFs and digital paper”, affirmed Dr. Abernethy. “We’re talking about digital transformation, use of cloud technologies, use of shared inter-operable data, digitized information.” -Amy Abernethy, M.D., Ph.D., former Principal Deputy Commissioner & Acting Chief Information Officer As Life-Science manufacturers embrace new technologies to … Continued

https://www.certara.com/axendia-industry-brief-fdas-digital-transformation-journey/

FDA Project Optimus

How prepared are you for Project Optimus? From dosing and study design to regulatory strategy and submission, we’ve got you covered. With the launch of Project Optimus, the FDA is reforming the dose optimization and dose selection paradigm in oncology drug development. With deep experience in model-informed oncology drug development, dosing and regulatory strategy and … Continued

https://www.certara.com/project-optimus/

Project Optimus: How to Prepare for Success

For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and Drug Administration’s (FDA) Oncology Center of Excellence for Oncology Drugs… By Julie Bullock, PharmD

https://www.certara.com/article/project-optimus-how-to-prepare-for-success/

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

https://www.certara.com/blog/essentials-of-model-informed-drug-development-midd-top-down-vs-bottom-up-approaches/

1 of 54