Stages of New Drug Development

Many people do not realize the amount of time and money it takes to take a commercial drug to market.  Here are some key things to remember:

  • Drug development is a very long process, the costs are extremely high, and the chance of success is very low
  • If a drug becomes commercialized, a lot is then riding on its success.
  • Our customers invest all of that time and money into getting the drug to market so cutting corners on a temperature controlled shipper can prove risky and in the end, costly.

Here is a very helpful graph from FDAReview.org that maps out the 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.

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