The Kinetics of Drug Binding

In order to ensure the safety of patients, the toxicological risk assessment needs to thoroughly evaluate all potential risks which may be caused by any component present in a pharmaceutical drug product.

Over the past few years, the gastroenterology diagnostic market has witnessed an increase in commercial multiplex diagnostic assays for the detection of a large array of enteric pathogens. These multiplex assays differ in many aspects, one important difference being the number of enteric pathogens that the assays detect. Updated IDSA/SHEA guidelines for the management of infectious diarrhea describe a targeted approach, directing proper test utilization for the diagnosis of infectious diarrhea. The guidelines can assist with the development of targeted testing algorithms to diagnose the enteric pathogens most likely causing disease. This patient-centric targeted testing approach can be supported by using the BD MAX ™ system, which uses separate testing panels for the detection of C. difficile, bacterial, parasitic, and viral pathogens.

In the realm of DNA sequencing, technology developers contribute to advancement in important ways, by building increasingly fast-moving tools that untangle the intricacies of the human genome, and by constructing analytics platforms to wade through the resulting mountains of genetic data.

Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products.