Developing Drugs

Question 1

What is the first main stage in drug testing?

Answer 1

1. In preclinical testing, drugs are tested on human cells and tissues in the lab.
2. However, you can’t use human cells and tissues to test drugs that affect whole or multiple body systems, e.g. testing a drug for blood pressure must be done on a whole animal because it has an intact circulatory system.

Question 2

What is the second main stage in drug testing?

Answer 2

Next step in preclinical testing is to test the drug on live animals. This is to test efficacy (whether the drug works and produces the effect you’re looking for), to find out about its toxicity and to find the best dosage (concentration that should be given, and how often).
2. Law in Britain states that any new drug must be tested on two different live mammals. Some people think it’s cruel to test on animals, but others believe this is the safest way to make sure a drug isn’t dangerous before it’s given to humans.

Question 3

What is the third main stage in drug testing?

Answer 3

1. If the drug passes the test on animals then it’s tested on human volunteers in a clinical trial.
2. First, the drug is tested on healthy volunteers. This is to make sure that it doesn’t have any harmful side effects when the body is working normally. At the start of the trail, a very low dose is given and this is gradually increased.
3. If results of tests on healthy volunteers are good, the drugs can be tested on people suffering from the illness. The optimum dose is found - this is the dose of drug that is the most effective and has few side effects.
4. To test how well the new drug works, patients randomly put into two groups. One is given the new drug, the other is given a placebo. This is so the doctor can see the actual difference the drug makes - it allows for the placebo effect.
5. Clinical trials are blind - the patient in the study doesn’t know whether they’re getting the drug or the placebo. In fact, they’re often double-blind - neither the patient nor the doctor knows until all the results have been gathered. This is so doctors monitoring the patients and analysing the results aren’t subconsciously influenced by their knowledge.
6. The results of drug testing and drug trials aren’t published until they’ve been through peer review. This helps prevent false claims.