Preclinical Testing
Laboratory and animal testing
Source:
PhRMA
, based on data from Center for the Study of Drug Development, Tufts University
Compound
Success
Rates by Stage
Discovery
(2–10 years)
Phase I
20–80 healthy volunteers used to
determine safety and dosage
Phase II
100–300 patient volunteers used
to look for efficacy and side effects
Phase III
1,000–5,000 patient volunteers used to monitor
adverse reactions to long-term use
EMEA/FDA Review/Approval
Additional Post-marketing Testing
7 million screened
7 million screened
150 enter discovery projects
12–15
development candidates
1–2
approved by
the EMEA/FDA
0
18
16
14
12
10
8
6
4
2
The Risky/Costly Process of
Pharmaceutical Innovation