Drug Development & Testing

• Aspirin is a common painkiller used to lower fevers. It is found in a chemical in the bark of willow trees.
• Digitalis which helps heart problems is found in foxgloxes.
• Penicillin was discovered by Alexander Flemming, a microbiologist in the 1920s. He left fungus in his lab and it had killed the surrounding colonies of bacteria. The fungus was called Penicillium, which we used to create penicllin.
• There are 3 main things to keep in mind when testing drugs: Efficacy (How well it works), Toxicity (How harmful it is), and Dosage (How much of the drug should be given).
• Preclinical Testing stages

  • Stage 1- Tested on human cells and tissues. This means we can cheapy test lots of substances, but it doesn't tell us how it would effect an entire organ or organism.
  • Stage 2- Testing on live animals (in the UK you must test on 2 mammals). As humans are mammals, this should give us a good idea of how our bodies would react and the efficacy and toxicity of the drug.
  • The first two stages are preclinical (not involving humans)
• Clinical testing stages

  • Stage 3- firstly give to healthy humans (low dose) to check it doesn't cause any problems. Slowly increase dose and check for side effects to find max dosage.
  • Secondly give the drug to people with the illness we are trying to cure. Slowly increase the dose until we find the optimum dosage (maximum efficacy and minimum toxicity).
• How to get a fair test

  • Use a placebo (looks like real drug but doesn't do anything).
  • Do a blind trial (do not tell who has the placebo and who has the drug)
  • Most trials are double-blind, so neither the doctors or volunteers know who had the real drug and who had the placebo until all the results have been analysed
  • This avoids any unconscious bias
• Once all drug tests are complete they are analysed and peer-reviewed to prevent false claims.