Table 3.   Median Preclinical and Synthesis-to-Approval Times (mos.) for Psychotropic and

                  All New Chemical Entities Approved in the United States, 1963-1997

 

 

Preclinical Phase

Synthesis-to-Approval Phase

 

 

Median

(Range)

 

N

Median

(Range)

 

 N

 

Antianxiety

 

18.2

(6.0-50.0)

 

  8

 

124.9

(48.0-223.0)

 

  8

 

 

Antidepressant

27.0

(0.0-51.9)

 17

188.0

(43.0-293.9)

 17

 

 

Antipsychotic

38.0

(3.9-120.0)

 12

127.5

(57.0-350.8)

  11

 

 

Sedative/

Hypnotic

20.0

(13.0-59.0)

 

 5

149.5

(99.0-186.0)

  5

 

 

Other NCEs

25.8

(0.0-240.0)

339

133.9

(31.9-359.7)

357

 

The preclinical phase is the time from first pharmacologic testing to first administration in humans

anywhere.  The synthesis-to-approval phase is the time from synthesis of the compound to U.S.

marketing approval.

 
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published 2000