Flashcards in Drug Development Deck (16):
Meta-analysis and Systemic review
non scientific evidence ex.
Situation happen and share
2 types of animal trial
Observational on a single point in time
DO NOT PROVE CAUSE and EFFECT
Compare exposure on a risk factor
DO NOT PROVE CAUSE AND EFFECT
Randomized controlled double-blind trial
T or F: Statistical difference is not the same thing than practical difference
study of studies
How drugs goes to markets? steps
2. In vitro and Animal Trials
3. Investigational new drug application (Phase I,II,III)
4.New drugs application
6. Review data, labelling, facilities.
7. Phase 4.
Accelerated approval for
Drugs for cure Cancer/ illness without cure or Tx.
Problems with clinical trials
Unnecessary risks (drugs should be better than others)
Subjects' comprehension of trials
Drugs need to have the same bioavailability than the generic one, need to show that
the maximum concentration reach in the same amount of time than the generic one.