Glossary

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  • SmPC
    The 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(...)
  • SST
    Danish Health Authority. https://sundhedsstyrelsen.dk"
  • Stratification
    In clinical trials, stratification is the separation of patients or the analysis of results based on something other than the treatment given.Stratification has two different meanings. In its first meaning, it describes the natural distribution of patients into subgroups. For instance,(...)
  • Stratified medicine
    Stratified medicine is based on the identification of subgroups of patients that differ in their mechanisms of disease, their susceptibility to a particular disease, or in their response to a medicine. The aim of stratified medicine is to offer the treatment that is most likely to give(...)
  • Study medication
    The 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 Population
    The 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.
  • Subcutaneous
    This 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(...)
  • Submission
    In 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(...)
  • Subpopulation
    Subpopulations 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 vaccine
    A vaccine derived from physical separation of the antigen from the pathogen.
  • Summary of Product Characteristics
    The 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(...)
  • Sundheldsstyrelsen
    Danish Health Authority. https://sundhedsstyrelsen.dk"

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