Glossary

A device used for the delivery of a medicine or therapeutic agent via a specific route of administration (e.g. inhaler, dermal patch or infusion pump).

Medicine delivery systems encompass four main related aspects:

1. Routes of delivery (ways in which the medications can be taken, such as orally, by injection, by inhalation, etc.).
   
2. Delivery vehicles (dosage forms such as pills or slow-release granules).
   
3. Chemical/biological properties of the active substance of the medicine (the cargo).
   
4. Targeting strategies (delivery methods that deliver medicines to specific organs, tissues, tumours or structures inside of cells).
   

Danish Institute for Local and Regional Government Research http://www.kora.dk/temaer-paa-tvaers/sundhedsoekonomi/"

German Agency for Health Technology Assessment of the DIMDI. http://www.dimdi.de/static/de/hta/index.htm"

The Development Safety Update Report is an annual review of safety information during clinical trials of a medicine under investigation “ whether or not it is marketed. The main objectives of a Development Safety Update Report is to:

• Summarise the current understanding and management of identified and potential risks.
  
• Describe new safety issues that could have an impact on the protection of clinical trial participants.
  
• Examine whether any new safety information is in line with previous knowledge of the product™s safety.
  
• Provide an update on the status of the clinical investigation/development programme and study results.
  

Developmental and reproductive toxicity (DART) is studied in animals to test chemical substances or medicines that might interfere with normal reproduction. This includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring (child).

An EU Directive is a form of legislation that is directed™ at the member states of the EU. Directives set out a goal or policy which needs to be achieved by the member states. A directive shall be binding upon each member state to which it is addressed, but shall leave to the national authorities the choice of form and methods. The member states are required to make the appropriate changes to their national legislation to implement the Directive. Normally this must be done within two years.

A wide range of issues is dealt with by directives, including some aspects of health and social policy.

The disability-adjusted life year (DALY) is a measure used in health economics. It represents the 'burden' of a disease, expressed as the number of years lost due to ill-health, disability, or early death. One DALY can be thought of as one lost year of 'healthy' life.

The total of DALYs across a population can also be thought of as a measurement of the gap between the population™s current health status and an ideal situation in which every person enjoys perfect health into old age.

Also known as ˜unmet need™ or ˜therapeutic need™. It may be a measure of the number of people affected by a particular disease for whom current treatments are inadequate. It may include the number of new diagnoses of a disease, or the costs to society or a government representing those affected. It may also include more qualitative aspects about the burden of disease and current treatments available to patients.

Dosage is a measured and specific amount of a medicine, with number, and frequency of doses over a specified period of time or prescribed intervals.