drug development

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  • drug development
    • drugs have to be tested and trialled before to check they are safe and effective
    • new drugs are tested for:
      • efficacy; make sure the drug works
      • toxicity; check that the drug is not poisonous
      • dose; the most suitable amount to take
    • preclinical trials; using cells, tissues and live animals
      • must be carried out before drug can be tested on humans
    • clinical trials; use healthy volunteers and patients
      • stage 1; healthy volunteers try small dose of drug to see if it safe and check for side effects
      • stage 2; a small number of patients try drug at a low dose to see if it works
      • stage 3; a larger number of patients- different doses are trialled to find optimum dose
      • stage 4; a double blind trial will occur.
        • the patients are divided into groups
          • some are given the drug some are given a placebo
            • a placebo can look identical to the new drug but contains no active ingredients
        • a double blind trial; patients and scientists don't know who receives the placebo or the drug
          • this avoids bias results
    • originally drugs were extracted from plants and micro-organisms
      • e.g. digitalis; extracted from foxglove plants (used as a heart drug)
      • e.g. aspirin; a painkiller and anti-inflammatory (found in willow bark)
      • e.g. penicillin; discovered by alexander fleming from the penicillium mould and used as an antibiotic

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