Discovery and development of drugs

Students should be able to describe the process of discovery and development of potential new medicines, including preclinical and clinical testing.

Traditionally drugs were extracted from plants and microorganisms.

• The heart drug digitalis originates from foxgloves.
• The painkiller aspirin originates from willow.
• Penicillin was discovered by Alexander Fleming from the Penicillium mould.

Most new drugs are synthesised by chemists in the pharmaceutical industry. However, the starting point may still be a chemical extracted from a plant.

New medical drugs have to be tested and trialled before being used to check that they are safe and effective.

New drugs are extensively tested for toxicity, efficacy and dose.

Preclinical testing is done in a laboratory using cells, tissues and live animals.

Clinical trials use healthy volunteers and patients.

• Very low doses of the drug are given at the start of the clinical trial.
• If the drug is found to be safe, further clinical trials are carried out to find the optimum dose for the drug.
• In double blind trials, some patients are given a placebo.