Results for: Pharmacokinetics

Adial Pharmaceuticals has successfully completed a pharmacokinetic (PK) study of its drug candidate AD04 for Alcohol Use Disorder (AUD). This study, which met FDA requirements, provides crucial data for optimizing the design of upcoming Phase 3 clinical trials and potentially securing approval through a 505(b)(2) pathway. The results demonstrated that AD04 delivers lower ondansetron exposure than standard ondansetron tablets due to its lower dose, but exposure increases proportionally with dose and can be taken with or without food.

Kangpu Biopharmaceuticals, a clinical-stage company, has successfully concluded a bridging clinical study of KPG-818 in China. This study evaluated the safety, tolerability, and pharmacokinetics of KPG-818 in healthy volunteers, paving the way for future clinical trials in patients.

Cancer chemotherapy dosing is currently calculated based on a simplistic formula that does not account for individual variations. This approach can lead to patients receiving either too much or too little of a drug, resulting in avoidable toxicity or insufficient benefit. MIT engineers have developed an alternative approach, called CLAUDIA, that personalizes the dose to the patient based on real-time measurements of drug concentration in the system. This closed-loop system compensates for differences in drug metabolism, genetic makeup, and other factors, potentially improving safety and efficacy.