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GCSE Biology · key term
Controlled testing of a potential medicine on human volunteers and patients.
Used by AQA, Edexcel and OCR
Specification 4.3.1.9 · Paper 1
Testing of a potential drug using healthy volunteers and patients.
Revise: Drug DevelopmentClinical trials use healthy volunteers and patients. At the start, very low doses are given. Healthy volunteers can provide evidence about safety and side effects without an illness obscuring the results.
Specification 5.20 · Paper 1
When asked to describe drug development, give the stages in order: preclinical testing on cells, tissues and live animals, followed by clinical trials using healthy volunteers and patients.
State that clinical trials usually begin with very low doses in healthy volunteers before testing patients with the condition.
Keep preclinical and clinical testing distinct: preclinical tests use cells, tissues and live animals; clinical trials involve people.
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Carefully controlled testing of a potential medicine in human volunteers and patients.
At this stage, efficacy, toxicity and dosage can be studied before clinical trials begin.
Specification B6.3q · Paper 2 (Foundation), Paper 4 (Higher)
Revise: New medicinesPreclinical testing takes place in the laboratory before clinical trials. A candidate is tested using cells and tissues. This can show whether it has the desired biological effect and whether it damages cells.