Glossary

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.

Dosage forms of a medicine are the means (or the form) by which drug molecules are delivered to sites of action within the body. There are several types of dosage form, depending on the method/route of delivery of the medicine. These include for instance pills, capsules, syrups, suppositories and solutions for injection. Typically this involves a mixture of the active substance(s) and non-active substances (excipients).

The dosage regimen is the schedule of doses of a medicine, including the time between doses, the duration of treatment and the amount to be taken each time. Dosage regimens also include how a medicine is to be taken, and in what formulation (dosage form).

A dose is a single, measured amount of a medicine to be taken at one time. This can be expressed as the forms (e.g. 1 capsule, 1 suppository), weight (e.g. 250 mg), volume (e.g. 10 mL, 2 drops), or some other quantity (e.g. 2 puffs).

Dose-Range Finding