Glossary

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  • Development Safety Update ReportThe 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(...)
  • Developmental and reproductive toxicityDevelopmental 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(...)
  • DARTDevelopmental 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(...)
  • DDC 
  • Direct Data Capture 
  • DirectiveAn 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(...)
  • DALYThe 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(...)
  • Disability-adjusted life yearThe 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(...)
  • Disease burdenAlso 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(...)
  • DosageDosage is a measured and specific amount of a medicine, with number, and frequency of doses over a specified period of time or prescribed intervals.

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