Biochemical
and Bioimaging Endpoints in Cardiocerebrovascular Diagnosis,
Prevention, Therapy and Drug Development
GLOSSARY
To
facilitate the dialogue among the multidisciplinary scientists,
definition of the acronyms and of more specialized terms have been
reported.
Every amendment is welcome.
By: Andrea P. Peracino
Stefano Bellosta
Nicola Ferri
Riccardo Roggeri
In general, efficacy is the ability to produce an effect, usually a specifically desired effect.The maximum ability of a drug or treatment to produce a result regardless of dosage.
510(k) Premarket Notification. Medical devices that are substantially similar to products already on the market can usually obtain FDA clearance via the agency's premarket notification process, known as a 510(k).. This review process is required for a few class I devices, most Class II devices and some Class III devices. In a 510(k) filing, the FDA requires that medical device manufacturers provide information and data (which may include clinical data) demonstrating that the new device is substantially equivalent to previously marketed devices and does not raise any new questions with respect to safety or efficacy.
