Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure

The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions).  Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.  Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of … Continued

Solving a Mystery Using PBPK: How Drug-excipient Complexes Can Confound a Metabolic DDI Result

Assessment of drug-drug interaction (DDI) liabilities is an important safety component of any drug development program. Itraconazole, a selective strong inhibitor of CYP3A, has been widely employed to determine the maximum drug interaction risk with new molecular entities as CYP3A substrates. Hydroxypropyl-β-cyclo-dextrin (HP-β-CD) is used as an excipient in the itraconazole solution for oral dosing … Continued

Using Virtual Twin™ Technology for Model-informed Precision Dosing

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

Best Practices in PBPK: The Case of Efavirenz

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

Annual Report—Simcyp Consortium Meeting

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

Seeing the Strategic Value of Modeling and Simulation Technology

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

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

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

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