Describe how new medicines are tested before they are made available to patients.

Eduqas GCSE Biology — 2.6.3 Medicines and drugs · Describe · 4 marks · View as Markdown

Written & reviewed by James Millett — Biology (Imperial College London), PGCE Science (University of Cambridge).

Model answer (4 marks)

New medicines are first tested in the laboratory or on cells and tissues (pre‑clinical testing). They are then tested on animals to check for safety, toxicity and side effects. After this, they are tested on healthy volunteers or a small number of people in clinical trials to confirm safety. Finally, they are tested on patients or a larger group of people to check effectiveness and determine the optimum dose.

Examiner tips

Use the sequence: laboratory → animals → healthy volunteers → patients
Mention safety, toxicity, side effects and effectiveness
Keep each step brief but include key terms

Common mistakes

Omitting the animal testing stage
Confusing healthy volunteers with patients
Using vague terms like "tested" without specifying safety or effectiveness

Mark scheme (4 marks)

New medicines are tested in the laboratory / on cells or tissues (preclinical testing)
Tested on animals to check for safety / toxicity / side effects
Tested on healthy volunteers / small number of people in clinical trials to check safety
Tested on patients / larger number of people to check effectiveness / optimum dose

Key terms in this question

medicines