Drug Development

Question 1

Who carried out the first drug tests?

Answer 1

William Withering

Question 2

How were the early drug tests carried out?

Answer 2

• made tea from foxgloves and gave to oedema (dropsy) patients until one died
• discovered + recorded side effects of digitalis
• discovered dosage was vital in success of medicine
• gradually increased dosage until vomiting/diarrhoea was induced to find correct dosage

Question 3

What is the active ingredient in foxgloves?

Answer 3

Digitalis, has effect on heart rate so was used to treat dropsy (caused by HBP from heart problems)

Question 4

Describe stages in modern drug testing

Answer 4

1 Pre clinical —> animal + laboratory studies on cells + tissues to test toxicity, assessing safety + effectiveness
2 Clinical trials phase I —> small group of healthy volunteers given drugs to test toxicity; see if it is absorbed, metabolised and excreted by body
3 Clinical trials phase II —> small group of people with disease are treated to look at efficacy
4 Clinical trials phase IIi —> large group of patients split into two groups; half given placebo and half active drug, done as double blind randomised controlled trial - if statistically significant results found showing efficacy, drug may be licensed + marketed
5 Phase IV —> drug tested and monitored after approval to see long term effects of the drug

Question 5

Define placebo

Answer 5

An inactive substance which causes no effect and is used for control group in drug trials

Question 6

Define double blind trials

Answer 6

When neither participants nor researcher know which treatment has been given to which participants; eliminates bias and placebo effect

Question 7

Where do aspirin, quinine, morphine and codeine come from and what are they used for?

Answer 7

Aspirin - willow tree, treats everyday pains like headaches, cold, etc.
Quinine - bark of Andean fever tree, used to treat malaria
Codeine & morphine - opiates from opium poppy, both strong painkillers for moderate (codeine) to severe (morphine) pain

Question 8

Describe different aseptic techniques

Answer 8

• pass inoculating loop through roaring blue flame to sterilise before & after spreading bacteria
• pass mouth and neck of flask containing bacterial culture through flame
• hold lid close to petri dish when spreading bacteria to avoid contamination from desk
• disinfect work surface and don’t place utensils directly on work surface
• use sterile equipment, sterilise glassware with autoclave
• work near Bunsen flame, kills bacteria in air