Drug development Flashcards
Stages of drug development
Drug chosen
pre-Clinical studies
Clinical Trials
Approved drug
Phase 1 Clinical trials
1)First exposure of drug to healthy humans.
2)Determines if effects of drug are similar to to those seen on animals
3)Correct dose determined
4)Identify side effects
Phase 2 Clinical trails
Is the drug effective in treating the disease?
Therapeutic and adverse effect is examined.
Phase 3 of clinical trails `
effect of drug compared to other standard therapeutic treatments.
If the drug is effective and safe to use then it is licensed by MHRA to use
Phase 4 of clinical trials
Surveillance of drug continues.
Long term effects especially of safety are evaluated.
How long does it take to create and sell drugs
20 years:
10 years for development
10 years to sell