Flashcards · Biology · Culturing Microorganisms and Developing Medicines
Developing New Medicines
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What are the main stages in developing a medicine?
Discovery, development, preclinical testing and clinical testing.
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What is preclinical testing?
Testing on cells, tissues and animals, before testing on humans.
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Why are animals used in testing?
They show effects on a whole body, such as side effects, that cells cannot show.
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What is tested in phase 1?
Safety, in a small number of healthy volunteers.
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What is tested in phase 2?
Whether it works, and the best dose, in a small group of patients.
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What is tested in phase 3?
Effectiveness compared with a placebo or standard treatment, in a large group of patients.
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What is a placebo?
A dummy treatment that looks the same but contains no active drug.
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What is the placebo effect?
Patients feel better because they believe they are being treated.
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What is a double-blind trial?
A trial in which neither the patient nor the doctor knows who receives the drug.
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Why are patients allocated at random?
So that the groups are alike, and the result is fair.
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How long does it take to develop a medicine?
About 10 to 15 years.
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Why is testing so expensive?
Many chemicals fail at each stage, and trials involve thousands of people.
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Name a medicine found in a plant.
Aspirin, from willow, or digitalis, from foxglove.
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Why are new antibiotics needed?
Bacteria evolve resistance to existing antibiotics.
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What did the thalidomide disaster show?
The need for thorough testing, including on pregnant animals.
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Common mistake about a placebo?
Thinking it is a drug. It contains no active ingredient.