development of drug testing Flashcards
(12 cards)
digitalis
heart conditions
what do drugs need to be tested for before theyre released to the public
effectiveness and any potential side-effects
pre-clinical trial testing
computers modelling potential effects
testing human tissues in the lab
animal testing
stages of clinical trials
if passed pre-clinical trial stages without problems it will be tested on humans
phase 1: small group of HEALTHY individuals to check for side-effects & correct dosage that should be taken
phase 2: larger group of unhealthy patients (who may require the drug)
determine effectiveness of the drug
phase 3: compared to existing drug to determine if its more or less effective
large number of patients split into 2 groups, each of which receives either existing or new drug
when are placebos typically introduced into clinical trials?
phase 2
what is the placebo
looks like the drug but contains no active ingredients
how are placebos used in clinical trials
patients split into 2 groups given either drug or placebo but both told they’re being given drug
whyre placebos useful
removes bias from investigation
humans may show placebo effect where changes to symptoms occur or they report changes because they think theyre being given a drug that will help with their medical issue- show improvements in their health due to the belief that theyre receiving the drug
when are double blind studies introduced in clinical trials
phases 2 and 3
neither doctors nor patients know if the patient is receiving the drug or the placebo
how are double blind clinical trials useful
removes bias
reducesthe effect that attitudes of the doctors or patients may have on the results
doctor may not report changes seen in patients health if they know the patient is receiving the placebo
digitalis soup: how does it help
william withering treated his patients suffering with heart failure using digitalis which strengthens heart muscle helping it to pump more effectively
helps to move fluid out of the body and into circulation which reduces swelling, particularly in the legs
dropsy=edema, swelling of tissues due to accumulation of fluid
can be caused by heart disease
took an extract from foxgloves (poisonous to humans) containing digitalis
what was digitalis soup?
as fox gloves are poisonous wittering made different versions of his remedy containing different concentrations of digitalis he called digitalis soup
experimented to find most effective concentration of digitalis that would treat dropsy without poisoning the patient