Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

Today’s announcement of a successful clinical evaluation of Plan A™ Contraception’s delivery method in 24 men comes shortly after NEXT Life Sciences’ announcement of the conclusion of an ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...

Optimizing your method development is key to obtaining accurate particle-sizing results with laser diffraction. However, ensuring that every standard operating procedure (SOP) is flawless can be ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...