Drug development pipeline Flashcards
(8 cards)
1
Q
What are the preclinical drug development stages
A
- Target ID
- Hit to lead
- Lead optimisation
- Pre-clinical development
2
Q
What are the clinical drug development stages
A
- Phase 1- initial human testing
- Phase 2- Efficacy in patents
- Phase 3- Large patient group trial
- Regulatory Approval
3
Q
What animal modes are used in pre-clinical development
A
Mouse
Rabbit
Dog
Minipig
4
Q
What animal is used for reproduction tox
A
Rabbit
5
Q
How many animals models have to be used for general tax in pre-clinical research
A
one rodent, one non-rodent
6
Q
What happens in phase I clinical trials
A
Healthy volunteers used other determine PK, PD and tolerability
7
Q
What happens in phase 2 clinical trials
A
Small scale study in patients to test effective dosages and tolerability
8
Q
What happens in phase 3 clinical trials
A
Efficacy and tolerability in large patient group, long term adverse events
