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
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
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
