Researchers obtained a substance from a bacterium living in seawater. They developed the substance into medicine M, which is intended to reduce the symptoms of a long-term condition.
The table shows evidence collected during the development of medicine M.
| Stage | Evidence |
|---|---|
| Preclinical tests on cells and tissues | The intended biological effect was observed. There was no obvious toxicity at the concentration planned for patients. |
| Preclinical tests on living organisms | Medicine M was absorbed and removed from the body. Harmful effects occurred at four times the dose planned for patients. |
| Early clinical trial | 40 healthy volunteers received a low dose that was increased gradually. Four reported mild side effects and none reported serious side effects. |
| Later clinical trial: medicine M | 400 patients received medicine M. Of these, 260 showed an improvement and 32 reported side effects. |
| Later clinical trial: placebo | 400 patients received a placebo. Of these, 140 showed an improvement and 12 reported side effects. |
Patients in the later trial were allocated to the groups at random. The later trial was double-blind.
Explain whether the evidence supports medicine M being licensed.
Include how the design of the later trial affects confidence in the evidence and what should happen before and after licensing.
87 exam-style questions on Edexcel GCSE Biology 5.3 Immune system and medicines, covering 5.3.1 The specific immune system, 5.3.2 Response to immunisation, 5.3.3 Advantages and disadvantages of immunisation, 5.3.4 Antibiotics and bacterial infections, 5.3.5 Aseptic techniques in culturing, 5.3.6 Cross-sectional areas of cultures, 5.3.7 Stages of developing new medicines, and 5.3.8 Production of monoclonal antibodies. Each one has a worked solution and a mark scheme showing where the marks go.