Glossary

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  • Study medicationThe study medication comprises the medicinal product(s) being given to participants in a trial (including a placebo). This also includes products already with a marketing authorisation but being used, formulated, or packaged in a new way, or being used to treat a new disease.
  • Study PopulationThe study population is the group of individuals in a study. In a clinical trial, the inclusion and exclusion criteria describe who will and will not be included, thus defining the characteristics of the study population.
  • SubcutaneousThis is the administration of a medicine into the layer of skin directly below the dermis and epidermis (the top layers of skin). Subcutaneous tissue has few blood vessels and so medicines administered here are for slow, sustained rates of absorption. An example is a local anaesthetic injected(...)
  • SublingualA route of medicine administration in which the medicine is placed under the tongue. These medications can come in the form of tablets, films, or sprays. It is an extremely fast pharmacological route of absorption, as medicines diffuse rapidly into the blood through tissues under the tongue.(...)
  • SubmissionIn order to market a medicine, a submission (an application) must be made to the relevant regulatory authority, for example the European Medicines Agency (EMA). Submissions provide comprehensive information about the medicine, its formulation, the trials it has undergone, its intended use, and(...)
  • SubpopulationSubpopulations are groups within a population. The population might be defined by, for example, the presence of a certain disease of interest to researchers. A subpopulation within that will have additional traits, such as disease severity, or failure of previous treatments, or specific(...)
  • Subunit vaccineA vaccine derived from physical separation of the antigen from the pathogen.
  • Summary of Product CharacteristicsThe Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as: How to use the medicine; What the medicine should be used to treat (therapeutic(...)
  • SmPCThe Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as: How to use the medicine; What the medicine should be used to treat (therapeutic(...)
  • SundheldsstyrelsenDanish Health Authority. https://sundhedsstyrelsen.dk"

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