Drug testing and Peer review

Question 1

how is new scientific evidence validated

Answer 1

1. research carried out to test a hypothesis
2. research paper is written
3. paper is sent of for a peer review
4. if the paper passes the peer review it is published in a scientific journal
5. the scientific evidence can then be shared ina. conference

Question 2

who carries out a peer review

Answer 2

scientists who work in the same field anonymously check the date by repeating the experiment

Question 3

William withering discovery

Answer 3

• William made an observation that drinking a herbal remedy cured dropsy
• identified foxglove as the active ingredient
• he increased the dose until the patient started to have diarrhoea and vomiting to find the optimum dose

Question 4

phase 1 (clinical trails)

Answer 4

• small group of healthy volunteers
• checks for safety in humans
• identifies side effects and maximum tolerated dose

Question 4

pre-clinical testing

Answer 4

• animal studies and tissue cultures
• identifies active ingredient
• tests for safety and effectiveness

Question 4

phase 2 (clinical trails)

Answer 4

• small group of patients with the illness (100-300)
• test for effectiveness in humans

Question 5

phase 3 (clinical trails)

Answer 5

• large group of patients with the illness(1-3000)
• double blind trails
• gives statistical evidence
• tests to see if the drug is better than exciting drugs or wether its the placebo effect

Question 6

after licensing

Answer 6

• date is still collected on effectiveness and safety
• identifies rare or long term side effects to confirm the clinical trails

Question 7

double-blind trails

Answer 7

where neither the patient or doctor know who is receiving the placebo, this is done to tests to see if the drug actually works and reduces bias in the results

Question 8

what is the placebo effect

Answer 8

a placebo has no active ingredients and helps to asses the validity of a drugs effect if the treatment has an effect above and beyond the placebo.