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/ "
  • Biotransformation
    Biotransformation is the process whereby a substance is changed (transformed) from one chemical to another by a chemical reaction within the body. Biotransformation is vital to survival because absorbed nutrients (food, oxygen, etc.) are transformed into substances required for normal body(...)
  • Bona fide
    Carried out in good faith; honest, without fraud or deception.
  • Branded Medicines
    Branded medicines are medicines which have a name given to them by a company for the purpose of advertising. The names of branded medicines are different from the International Nonproprietary Name (INN), also known as the generic name. Branded medicines may be the original medicine developed(...)
  • 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(...)

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