L10 - Drug development I Flashcards
What was the problem with Elixir Sulfanilamide?
Was found to contain diethylene which killed 107 people
What was the problem with Sulfathiazole Tablets?
They were tainted with the sedative Phenobarbital and caused 300 deaths.
What was the proboem with Thalidomide? (sleeping pill)
Caused some birth defects
What happens in the first 3-6 years of drug trials?
Basic research/target selection and pre-clinical research or animal testing.
What happens after 6-7 years in drug trials?
Phase 1-3 of clinical research
What happens after 10 years in drug trials?
the regulatory review - looking to get the drug on the market
What companies carry out the pre-clinical and clinical research?
Contract reasearch organisations
Who gives the approval for the drug to be put on the market?
Regulatory authorities eg. FDA
What are the goals of non-clinical safefty evaluations?
- To determine the maximum non-toxic does and minimum affective dose
- To relate toxicity to the exposure
Why was Hydromorphane (narcotic painkiller) withdrawn?
Due to a high risk of accidental overdoses with alcohol
Why was Rimonabant (anti-obesity drug) withdrawn?
Caused severe depression and suicides
Why was Sibutramine (appetite supression drug) withdrawn?
Caused heart attacks
Why was Propoxyphene (opiod painkiller) withdrawn?
Caused heart attacks and strokes
