open label extension study definition
As the name implies, an open-label extension study is an ‘appendage’ to a randomised controlled clinical trial, usually of an unregistered medicine or intervention. Often the drug is being studied under an investigational new drug (IND) licence or equivalent legislation.he number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them.
MAP (modified atmosphere packaging): a packaging method in which a combination of gases such as oxygen, carbon dioxide and nitrogen is introduced into the package at the time of closure. Purpose is to extend shelf life of the product packaged. (example: lunch meat in a blister package).