clinical trials Flashcards
1
Q
considerations in trial design
A
- does it work?
- whats dose works?
- what dose is toxic?
- is it safe?
- is it necessary?
2
Q
stages of clinical trials
A
- pre clinical
- clinical
- I volunteer studies
- II iller patients
- III former part
- IV post marketing surveillance
3
Q
pre clinical stage
A
animal testing
tissue culture
4
Q
clinical: stage I
A
volunteer study on normal people
for pharmacokinetic data
can be bypassed- e.g chemotherapy
5
Q
clinical: stage II
A
on iller patients- renal, liver, GI problems
to see efficacy and dosage
6
Q
clinical: stage III
A
efficacy and safety
- randomised control
- crossover
7
Q
clinical stage III randomised control
A
lots of patients needed
patients might refuse as not all get treatment
8
Q
clinical stage III crossover
A
takes long
lots of dropouts
