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B3.4–3.5 · 4.3.1.9–11Paper 1✅ Year 10 — already covered

Drug Development & Monoclonal Antibodies

Clinical trials, double-blind trials, placebo, thalidomide. Monoclonal antibodies: production and uses. Higher tier content.

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Key facts

Drug development and testing — fill in the table

TermDefinition
Testing requirements
Preclinical testing
Clinical trials
Double-blind trial
Placebo
Thalidomide

Monoclonal antibodies — production — fill in the table

TermDetail
Hybridoma cell
Production
Specificity
Uses
Exam questions — 3 questions · 11 marks
⚡ Extended questions included. Read the hint. Write in full sentences. AI marks against the AQA mark scheme.
1 markDouble-blind trialAQA 8461 P1 style

Why is a double-blind trial used when testing a new drug?

A So the drug company does not know the results until the trial is finished
B To ensure neither the patient nor the doctor knows who is receiving the drug or placebo, eliminating bias from both sides
C So the drug can be tested on twice as many patients
D To test two different drugs against each other simultaneously
4 marksMonoclonal antibody productionAQA 8461 P1 Higher style

Describe how monoclonal antibodies are produced and explain why they are useful for treating cancer. (4 marks)

Hint: Production: antigen → lymphocytes → hybridoma (lymphocyte + tumour cell) → many identical antibodies. Cancer treatment: antibody attached to drug/radioactive substance → targets specific cancer cell antigens.
+40 XP
1 markThalidomide lessonAQA 8461 style

What was the main lesson learned from the thalidomide case for drug development?

A All drugs must be tested on pregnant women before approval
B Drug testing must be more rigorous and include testing for effects on pregnancy before a drug is approved
C Sleeping pills should never be prescribed
D Animal testing is not reliable and should be abandoned
Quick recall flashcards

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