This blog explains how model-informed drug development (MIDD) can inform and accelerate a COVID-19 therapeutics program.
Tag: Drug-drug Interactions
In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare … Continued
According to the FDA’s Guidance for Industry on Drug-drug interactions (DDIs), assessment of a new drug’s DDI liability has three major objectives: determining whether any interactions necessitate dosing adjustment, informing the extent of therapeutic monitoring that may be required and identifying any potential contraindications to concomitant use when lesser measures cannot mitigate risk Physiologically-based pharmacokinetic … Continued
It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic … Continued
They say beauty is in the eye of the beholder. One could also say that the benefits of modeling and simulation (M&S) are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, … Continued
Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the … Continued