EDEXCEL GCSE HEALTH DISEASE AND MEDICINE part 3 - Drugs, Clinical Trials and Non-communicable Diseases

Sep 5, 2026

EDEXCEL GCSE Health Disease and Medicine part 3 explains how new drugs, including antibiotics, are tested for efficacy, toxicity and appropriate dose before use in humans. It outlines preclinical trials with cells, tissues and live animals, then describes clinical trial stages using healthy volunteers and patients, including double-blind placebo-controlled design to reduce bias. The material also covers placebo use, monoclonal antibodies and their production, plus non-communicable diseases, interacting lifestyle and genetic factors, and treatment options for cardiovascular disease like medication, surgery and lifestyle changes.

LanguageEnglish

CategoryExam

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

Drugs testing and trial stages

Efficacy, toxicity and dose

Preclinical and clinical trials

Double blind trials and placebo

Monoclonal antibodies

Non-communicable diseases and risk factors

Disease categories and interacting factors

Lifestyle factors and effects

Obesity, malnutrition and BMI/waist-hip ratio

Evaluating treatments for cardiovascular disease (CVD)

Life-long medication, surgical procedures and lifestyle changes

EDEXCEL GCSE HEALTH DISEASE AND MEDICINE part 3 Drugs ( including antibiotics) have to be tested and trialled before to check they are safe and effective | | Efficacy | Make sure the drug works | | --- | --- | --- | | | Toxicity | Check that the drug is not poisonous | | | Dose | The most suitable amount to take | Preclinical trials-using cells, tissues and live animals-must be carried out before the drug can be tested on humans. Clinical trials use healthy volunteers and patients | Stage 1 | Stage 2 | Stage 3 | Stage 4 | | --- | --- | --- | --- | | Healthy volunteers try small dose of the drug to check it is safe record any side effects | A small number of patients try the drug at a
low dose
to see if
it works | A larger number of
patients; different doses are
trialled to find the optimum dose | A double blind trial will occur. The patients are divided into groups. Some will be given the drug and some a placebo. | Double blind trial: patients and scientists do not know who receives the new drug or placebo until the end of the trial. This avoids bias. A placebo can look identical to the new drug but contain no active ingredients Monoclonal antibodies (Biology only HT) | | Identical
copies of
one types
of
antibody
produced
in
laboratory | 1. A mouse is injected with pathogen. | | --- | --- | --- | | | | 2. Lymphocytes produce antibodies (but do not divide) . | | | | 3. Lymphocytes are removed from the mouse and fused with rapidly dividing mouse tumour cells. | | | | 4. The new cells are called hybridomas. | | | | 5. The hybridomas divide rapidly and release lots of antibodies which are then collected. | Specific to one binding site on the antigen. Can target specific chemicals or cells in the body unlike drug and radiotherapy treatments. | Monoclonal antibodies can be used in a variety of ways | | | --- | --- | | Testing | Diagnosis | | e.g. pregnancy test – measure the level of hormones | Can detect very small quantities of chemicals in the blood | Non-communicable diseases | | Disease | Interacting factors | | --- | --- | --- | | | Cardiovascular disease | Diet, obesity, smoking, drinking alcohol, lack of exercise, genetics. | | | Cancer | | | | Lung disease | | | | Liver disease | | | | Malnutrition | | | | Disease | lifestyle factors | | --- | --- | --- | | | Obesity and
malnutrition | Lack of exercise and consuming too many/too few calories through an unbalanced diet. Schools meals are balanced to combat this in young people. | | | Liver disease | Large amounts of alcohol taken over a long period of time can lead to liver disease e.g. cirrhosis. The NHS spends over £500 million a year treating liver disease. | | | Cardiovascular disease | Smoking leads to damage and blocking of arteries supplying the heart with oxygenated blood. WHO estimates that 6 million people die globally as a result of smoking related illnesses. | Healthy weight can be calculate using waist:hip ratio and the equation for BMI. 􀡮􀡹􀡵 = 􀢓􀢇􀢙􀢙 (􀢑􀢍) 􀢎􀢋􀢏􀢍􀢎􀢚 􀢓 􀫛 | Evaluating different treatments for cardiovascular disease (CVD) | | | | --- | --- | --- | | Life long medication | Surgical procedures | Lifestyle changes | | Medicines to reduce blood pressure and cholesterol. Statins for lowering cholesterol carry a small risk of developing diabetes. | A stent can be surgically inserted into blocked bloodvessel. Blocked blood vessels can be bypassed with inserted blood vessels. This treatment requires life long medication. | Giving up smoking, drinking excess alcohol and taking more exercise can reduce the risk of CVD. Some patients may not stick to lifestyle changes. | Non-communicab le diseases are caused by the interaction of a number offactors Lifesty le factors and their effects on non-communicab le disease New drugs are extensively tested for: Treating CVD Monoc lo na l antibodies better hope – brighter future EDEXCEL GCSE HEALTH DISEASE AND M

FAQs

Why must drugs be tested before they are used in humans?

Drugs must be tested to check they are safe and effective. Testing also helps determine whether they cause toxicity and what dose is most suitable.

What happens in a double blind trial?

Patients and scientists do not know who receives the new drug or the placebo until the end of the trial. This avoids bias, and the placebo can look identical to the drug.

How do monoclonal antibodies work and how are they produced?

Monoclonal antibodies are specific to one binding site on an antigen, so they can target particular chemicals or cells in the body. They are produced by creating hybridomas that rapidly divide and release large quantities of antibodies collected later.

Sep 5, 2026

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