De-risking cardiac toxicity: The Evolution of QT/QTc Assessment in Drug Development
La découverte d’un nouveau traitement était souvent compromise par un obstacle imprévu et tardif : la toxicité cardiaque induite par les médicaments. Le retard involontaire de la repolarisation ventriculaire, mesuré par l’allongement de l’intervalle QT, a été l’une des principales causes de retrait de médicaments.
Navigating regulatory expectations in Model-Informed Drug Development
Once confined to the fringes as an experimental approach, Model-Informed Drug Development (MIDD) has now become one of the cornerstones of the pharmaceutical regulatory framework.
Avoiding Late-Stage Failure in Oncology Through MIDD
Late-stage attrition in oncology drug development represents a substantial scientific and economic inefficiency, with Phase III failure rates often exceeding 50%
Dose optimization in oncology: a hidden MIDD challenge in the era of project Optimus
For decades, oncology followed a simple principle: administer the maximum tolerated dose. With modern therapies, this paradigm no longer holds — discover how MIDD addresses the FDA's new Project Optimus expectations.
Modeling & Simulation integrated in drug development
Modeling and simulation play an increasingly crucial role in the development of drug candidates.
New article: Unlock the power of PBPK Prediction!
In the ever-evolving landscape of pharmaceutical research, the quest for developing safer and more effective drugs is a continuous endeavor.