Drug Development

• From what sources can chemicals be extracted for drug development, according to the text?

  Foxgloves, willow trees, and Penicillium mold
• Who might make drugs from the extracted chemicals?

  Chemists in pharmaceutical companies
• What might be the starting point for drug development?

  A chemical extracted from plants
• What defect was associated with thalidomide?

  Phocomelia, a defect of the limbs
• What kind of drug was thalidomide?

  A drug
• Why were pregnant women taking thalidomide?

  For morning sickness
• What has the thalidomide disaster led to?

  New restrictions on how drugs are developed
• What are the three stages of drug development?

  • Discovery
  • Pre-clinical
  • Clinical
• Who peer reviews clinical trial results?

  Medical professionals
• What must happen to clinical trial results before they are shared?

  They are peer reviewed
• What is a potential risk of clinical trials?

  Unexpected side effects can occur
• What is an effective drug designed to do?

  Prevent or cure a disease or make you feel better
• What does it mean for a drug to be safe?

  Not too toxic or with undesirable effects
• What is meant by dosage?

  The amount of drug to safely use
• What characteristic should a drug have to be considered stable?

  It must be possible to store any remaining drug
• What is the aim of preclinical testing?

  Test for toxicity and to see if it works
• What is used in preclinical testing?

  Cells, tissues and animals
• In Phase 1 clinical trials, who is the drug tested on?

  Healthy volunteers using very low doses
• What is the aim of Phase 1 clinical trials?

  Test if it is safe, work for side effects, toxicity
• In Phases 2 and 3 clinical trials, who is the drug tested on?

  Patients with the disease
• What is the aim of Phase 2 and 3 clinical trials?

  Test for efficiency, side effects, optimum dose
• What type of procedure is normally used in Phases 2 and 3 clinical trials?

  Double blind
• How are patients typically split into groups during Phases 2 and 3?

  Randomly split into two groups
• What is given to one group of patients in a double-blind clinical trial?

  Placebo
• In a double-blind study, who knows who is given the drug vs placebo?

  Neither doctor or patients
• Why is drug stability an important factor in drug development?

  To allow storage of any remaining drug