B3- Developing drugs

• What must happen before new drugs can be given to the general public?

  They must go through a thorough testing procedure.
• What are the three main stages in drug testing?

  1. Preclinical testing
  2. Testing on live animals
  3. Clinical trials on human volunteers
• In preclinical testing, where are drugs tested?

  On human cells and tissues in the lab.
• Why can't human cells and tissues be used to test drugs that affect whole body systems?

  Because these drugs must be tested on an intact circulatory system.
• What is the purpose of testing drugs on live animals in preclinical testing?

  To test efficacy, toxicity, and find the best dosage.
• What does the law in Britain state about testing new drugs?

  Any new drug must be tested on two different hot mammals.
• What are the differing opinions on animal testing for drugs?

  Some think it's cruel, while others believe it's the safest way to ensure drugs aren't dangerous.
• What happens if a drug passes tests on animals?

  It is tested on human volunteers in a clinical trial.
• Why are healthy volunteers tested first in clinical trials?

  To ensure the drug doesn't have harmful side effects when the body is working normally.
• What is done to the dosage of the drug during the trial with healthy volunteers?

  A very low dose is given initially and gradually increased.
• What is the optimum dose in drug testing?

  It is the dose that is most effective and has few side effects.
• How are patients grouped in clinical trials to test drug efficacy?

  Patients are randomly put into two groups: one receives the drug, the other a placebo.
• What is a placebo?

  A substance that resembles the drug being tested but has no therapeutic effect.
• Why are clinical trials often blind or double-blind?

  To prevent subconscious influence on results from patients or doctors knowing who receives the drug or placebo.
• What must happen to the results of drug testing before they are published?

  They must go through peer review.
• What is the purpose of peer review in drug testing?

  To check that the work is valid and has been carried out rigorously.
• What does the placebo effect refer to?

  When a patient expects the treatment to work and feels better, even though the treatment isn't doing anything.