Throughout drug development, it is important to characterize and quantify pharmaceutical compounds and any associated metabolites to ensure proper drug safety and efficacy. LC-MS/MS techniques are predominantly used for such analyses because they provide a comprehensive outlook and can offer a sensitive and selective approach for the quantification of compounds. However, limited deep fragment coverage and sensitivity challenge the confident identification and quantification of metabolites and drug products. Here, alternative fragmentation paired with a highly sensitive QTOF system was employed for comprehensive data collection to properly identify metabolites and quantify complex peptide therapeutics.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.