Drug Development Flashcards
Symptoms of foxglove poisoning
-irregular heart beat, dizziness, vomiting
What was foxglove used to treat and symptoms of this
Used to treat dropsy(oedima) which is accumulation of fluid in the body’s tissue by heart and kidney problems resulting in increased blood pressure
What did William Withering do
He was the first to record and discover side effects which he did of foxglove on oedima patients and increased dosage of foxglove tea until diarrhoea and vomiting induced and then decreased dosage from that point to find correct dosage for each patient
What must a new drug be
Must be proven to be effective which outweighs the side effects and find a safe dosage
What happens during pre-clinical testing stage
Test the drug on cells and tissues then on animals to test for toxicity and preliminary effectiveness
What happens during phase 1 of clinical testing
Small group of healthy volunteers given the drug to see if it is absorbed, metabolised and excreted by the body by the predicted mechanisms (testing toxicity and side effects)
What happens during phase 2 of clinical testing
Small group of people with disease tested to see efficacy of the drug
What happens during phase 3 of clinical testing
Large group of patients with the disease split into placebo/active drug in double blind randomised controlled trial and if statistically significant results come back showing drug has worked drug licensed and marketed. After licensing the trials continue collecting data on effectiveness and safety
What is a placebo
Drug with no active ingredients used as a control
Why randomly assign participants and use double blind trial
To prevent bias
What is the placebo effect
When patients taking the placebo seem to get better however this is just a psychological effect
