Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.
The drug development process requires pharmacokinetic (PK) analysis to be performed as part of safety and efficacy studies in both preclinical species and human subjects. For high-sensitivity bioanalysis, liquid chromatography (LC) coupled to a triple… Read more >
The quality issues of biopharmaceutical therapeutics are definitely different from chemical drugs because of the increased complexity of manufacturing processes and complexity of the biologic molecules themselves. There is an increasing need for detailed product… Read more >
Empower® 3 Method Validation Manager (MVM) allows you to perform chromatographic method validation, from protocol planning through final reporting, in one application. Recently, we sponsored a webinar showing ways you can streamline your workflow throughout… Read more >
Webinar: QbD Development of a Purity Method Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The… Read more >