Drug Testing Flashcards
Who discovered digitalis?
William Withering
What was the plant containing digitalis called?
Foxglove
What disease was Withering attempting to treat?
Dropsy – swelling brought about by heart failure
How did Withering discover foxgloves as a cure? 2
- Patient suffering from dropsy made a good recovery after treating themselves with traditional home remedy containing foxgloves
- Withering isolated digitalis from foxglove plants as active ingredient
What was Withering’s first step in testing the drug? 3
- Tested it on 2 patients
- One recovered
- One nearly died
What was Withering’s second step testing the drug? 2
- Tested it on a larger group of patients
- Discovered and recorded side effects
What was Withering’s final step testing the drug?
Determining the dosage
How did Withering determine the drug dosage? 4
- Trial and error
- He slowly increased concentration until the patients experienced bad side effects
- Reduced it slightly
- If he had reduced it too much – drug would have had no effect
What is the first step in modern drug test testing?
Active ingredient is isolated and manufactured synthetically
What happens in pre-clinical testing? 3
- Computers model potential effects
- Tests on human tissues in a lab
- Animal testing
Who is tested in Phase 1?
A small group of healthy individuals
Who is tested in Phase 2?
A small group of patients
Who is tested in Phase 3?
A large group of patients
What is tested in Phase 1? 3
- Safe dosage
- Side effects
- How body reacts to drug
What is tested in Phase 2?
Drug’s effectiveness
What is tested in Phase 3?
Drug’s effectiveness in a large sample
What is a placebo?
An inactive substance that looks like the drug but no effect
What is the placebo effect?
Patients show an improvement because they believe they are receiving the treatment
How is a placebo used? 2
- Patient sample split into 2 groups – one with placebo and one with real drug
- Patients should improve more with real drug than with placebo
What can be used as a placebo?
An existing treatment if new drug is an improvement
What is a double blind trial?
- Neither patients/doctors know who has been given the new drug or treatment or the placebo
- Reduces bias – attitudes cannot affect result
Define antimicrobial
Ability to kill/slow down growth of microorganisms