Drug approval Flashcards
Number of animal species a new drug must be tested on before human trials
2
Number of phases in human trials
4
Purpose of phase I drug trials
Determine if the drug is safe for humans
Purpose of phase II drug trials
Evaluate effectiveness compared to placebo
Type of volunteer used in phase I drug trials
Healthy volunteers, often male
Purpose of phase III drug trials
Evaluate superiority or equivalence compared to standard treatments
Phases of trials a new drug must go through before it is approved
3
Purposes of phase IV trials - post-marketing trials
Investigate rarer side effects
Gather further information in areas not already investigated e.g. safety in pregnancy or while breastfeeding
Find other potential uses for the drug
Adverse effect of nefazadone discovered in post-marketing surveillance
Hepatotoxicity
Adverse effect of thioridazone discovered in post-marketing surveillance
QTc prolongation
Adverse effect of sertindole discovered in post-marketing surveillance
Sudden cardiac death
Adverse effect of thalidomide discovered in post-marketing surveillance
Phocomelia
Adverse effect of zimeldine discovered in post-marketing surveillance
Hypersensitivity reactions
Guillain-Barré syndrome
Adverse effect of MAOIs discovered in post-marketing surveillance
Cheese reaction
Adverse effect of clozapine discovered in post-marketing surveillance
Agranulocytosis
