http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm
http://www.fdareview.org/03_drug_development.php
An Overview of the Drug Development Process
|
Preclinical
|
Clinical
|
Approval
|
Market
|
|||
|---|---|---|---|---|---|---|
|
Toxicology
|
Investigational New Drug Application
|
Phase I
|
Phase II
|
Phase III
|
New Drug Application
|
Phase IV / Postmarket surveillance
|
|
safety
|
safety dosing efficacy
|
safety efficacy side effects |
||||
|
Expenses
|
|
$15.2 million
|
$23.4 million
|
$86.5 million
|
||
|
Time
|
|
21.6 months
|
25.7 months
|
30.5 months
|
||
|
1 to 6 years
|
6 to 11 years
|
0.6 to 2 years
|
11 to 14 years
|
|||
|
Overall probability of success
|
||||||
|
30%
|
14%
|
9%
|
8%
|
|||
|
Conditional probability of success
|
||||||
|
40%
|
75%
|
48%
|
64%
|
90%
|
||
| Sources: Dimasi, Hansen, and Grabowski (2003). | ||||||
| Notes: The line marked “Overall probability of success” is the unconditional probability of reaching a given stage. For example, 30 percent of drugs make it to phase I testing. The line marked “Conditional probability of success” shows the probability of advancing to the next stage of the process conditional on reaching a given stage. For example, the probability of advancing to Phase III testing conditional on starting Phase II testing is 48 percent. |
||||||
