Medicine Development Flashcards

1️⃣ Familiarise yourself with the flashcards:

  • Look through all the flashcards to see what's on both sides.
  • Make sure you understand the information on each card. If something's unclear, click the link to the revision notes at the bottom of the page for more details.

2️⃣ Test yourself:

  • Look at the question or prompt on each card and try to remember the answer before flipping it over.
  • Check the answer and make a note of any cards you find challenging and need to go over more.

3️⃣ Consistently Review and Practice:

  • Use spaced repetition: spend more time on the cards you struggle with and go over them more often.
  • Regularly review all the flashcards to help you better understand and retain the information over time.

Note: We may include questions that have multiple correct answers. It's useful to remember specific examples to understand these concepts better.

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What are the three main things scientists test in a new medicine?

Efficacy (does it work), toxicity (is it safe), and the best dose.

What is preclinical testing?

Tests done before people. The drug is tested on cells or tissues, then on animals, to check safety and if it works.

What is a clinical trial?

Testing a drug on humans to check safety, side effects, how well it works, and the best dose.

What happens in a Phase 1 trial?

A very low dose is given to a small group of healthy volunteers. The dose is raised slowly to find a safe range and spot side effects.

What happens in a Phase 2 trial?

The drug is tested on a small number of patients with the illness to see if it works and to help set the right dose.

What happens in a Phase 3 trial?

The drug is tested on many patients. It is compared with a placebo or the best current treatment, often in a double-blind test.

What is a placebo?

A dummy treatment with no active drug. It is used to see if the real drug works better than no drug.

What does double-blind mean in a trial?

Neither the patients nor the doctors know who gets the real drug or the placebo. This reduces bias.

What is the control group in a drug trial?

The group that does not get the new drug (they get a placebo or standard treatment). Results are compared with this group.

What is meant by the optimum dose?

The smallest dose that gives the best effect with the fewest side effects.

Why are trial results peer reviewed before publishing?

Other scientists check the methods and data. This helps spot errors and reduces bias.

What must happen before a new drug can be used by the public?

A regulator must license it based on trial data, to show it is safe and works.