Glossary

AJAX progress indicator
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  • BASG
    Austrian National Competent Authority. http://www.basg.gv.at/"
  • BDA
    Bulgarian National Competent Authority. https://www.bda.bg/en/"
  • BfArM
    German National Competent Authority. http://www.bfarm.de/ "
  • Budget impact
    Costs within a particular timeframe and related to a particular healthcare budget rather than a country’s overall budget. This assumes robust data on epidemiology and treatment patterns, along with assumptions of uptake and displacement of current treatments.
  • Bulgarian Drug Agency
    Bulgarian National Competent Authority. https://www.bda.bg/en/"
  • Bundesamt für Sicherheit im Gesundheitswesen
    Austrian National Competent Authority. http://www.basg.gv.at/"
  • Bundesinstitut für Arzneimittel und Medizinprodukte
    German National Competent Authority. http://www.bfarm.de/ "
  • Candidate drug
    In the medicines development process, this is the compound among several (compounds), which meets criteria in efficacy and safety in order to be used in clinical trials with humans. Broad information on the mechanism of action and pharmacology has to be available for a candidate drug.
  • Candidate Gene
    A candidate gene is any DNA sequence (gene) in a chromosome considered likely to cause a disease. The gene may be a candidate because it is located in a particular chromosome region involved in the disease, or its protein product is suspected to be the cause of the disease. Candidate genes(...)
  • Carcinogenicity studies
    Studies that use animal models to evaluate the carcinogenic potential of pharmaceuticals. They are also used to test chemicals and food additives. The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. Any cause(...)
  • Case Control Studies
    A case control study is one that compares two groups retrospectively.For example, people who developed a disease might be compared with a group of people who have not. The researcher will look at whether there is any difference in the two groups in their previous exposure to possible risk(...)
  • Case report form
    A case report form is a paper or electronic data entry form used in clinical trials. It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant. All the data on each individual taking part in a clinical trial, including information on(...)
  • Causal relationship
    Is the relation between an event (the cause) and a second event (the effect), where the effect is a direct consequence of the cause.
  • CRF
    A case report form is a paper or electronic data entry form used in clinical trials. It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant. All the data on each individual taking part in a clinical trial, including information on(...)

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