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Development of MedicinesEdexcel GCSE Biology: Revision notes

Section 1

Stages of Developing New Medicines

  1. Discovery 2. Development 3. Preclinical testing (cells/tissues/animals) 4. Clinical testing (human volunteers, then patients, double-blind trials with a placebo).
Key termsantibioticspreclinical testingclinical testingdouble-blind trialplacebo
Exam tip

Order: discovery → development → preclinical → clinical.

Section 2

Monoclonal Antibodies: Production

  1. Mouse injected with antigen; lymphocytes produce antibody but cannot divide indefinitely
  2. Fused with a tumour cell → hybridoma cell
  3. Hybridoma divides, producing antibody
Key termsmonoclonal antibodylymphocytehybridoma cell
Common mistake

Lymphocytes alone can't be cloned — it's the hybridoma cell that divides.

Section 3

Uses of Monoclonal Antibodies

Pregnancy testing (hCG), diagnosis (locating blood clots/cancer cells), treatment (targeted cancer therapy). Advantage: targets specific cells only, sparing healthy tissue vs drugs/radiotherapy.

Key termsantigenhCG

Section 4

Non-Communicable Diseases and Lifestyle

Cardiovascular disease, cancer, lung/liver disease, nutrition-related disease result from multiple factors.

Diet+inactivity → obesity/malnutrition; alcohol → liver disease; smoking → cardiovascular disease.

BMI = mass(kg) ÷ height(m)².

Key termsnon-communicable diseaseobesitymalnutritionBMIwaist:hip ratio
Example

70kg, 1.75m: BMI=70÷3.0625=22.9.

Section 5

Treating Cardiovascular Disease

Life-long medication (statins) — ongoing, side effects. Surgery (stents/bypass) — effective, risky, costly. Lifestyle changes — low risk, needs commitment.

Key termsstatinsstentcoronary bypass
Exam tip

Weigh cost, effectiveness, risk, compliance.

Must Know

  • Stages: discovery→development→preclinical→clinical (double-blind, placebo).
  • Hybridoma = lymphocyte + tumour cell, produces monoclonal antibody.
  • Uses: pregnancy test, diagnosis, targeted treatment.
  • BMI=mass÷height²; smoking→CVD, alcohol→liver, diet/exercise→obesity.
  • CVD treatments: medication, surgery, lifestyle — each with trade-offs.

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