The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...

Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

Clinical trials give patients hope — especially when all other available treatments have been exhausted. That hope compels patients to commit a substantial amount of time and effort for the chance to ...

Engineered oncolytic bacteria have emerged as a promising therapeutic platform for precision cancer treatment, offering tumor-specific colonization, immune activation, and controllable therapeutic ...

New pharmaceuticals, cleaner fuels, biodegradable plastics: in order to meet society's needs, chemists have to develop new synthesis methods to obtain new products that do not exist in their natural ...

To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical ...

The KeyCode Open API architecture native to Key Digital offers a simple means of extending digital AV network control. When you purchase through links on our site, we may earn an affiliate commission.