The following table outlines the typical duration for various types of preclinical studies and the preferred timing relative to clinical trials they support.
Pre/Nonclinical Study
|
Duration
|
Time
|
Clinical Study Supported
|
Safety pharmacology
Toxicokinetic, pharmacokinetic studies
Single dose acute toxicityor dose escalation study in two species
Local tolerance studies using relevant route of administration |
1-3 weeks, depending on kinetic data
14 days
A few hours to several weeks depending on sample and test type
|
Prior to Phase I. Information should be available by the time early Phase I trials are completed. |
Phase I/II
|
Repeated dose toxicity studies in one rodent and one non-rodent model
|
Should equal or exceed the duration of Phase I/II studies: (minimum 2 weeks, maximum 12 months; generally 1-3 months for biotech-derived products )
To support Phase III:
1 month
3 months
6 months
|
Prior to Phase I
Prior to Phase III
|
Phase I/II:
2 weeks to
12 months
Phase III:
< 2 weeks
< 1 month
> 1 month
|
Genotoxicity studies
|
Variable
|
Complete prior to start of Phase II and all pediatric clinical trials
|
Phase I/II
Pediatric clinical trials
|
Reproductive toxicity studies
|
(> 1 month-long repeated dose toxicity studies required prior to tests).
Pre-mating treatment interval of 4 weeks for males and 2 weeks for females.
Continue treatment throughout mating for males and at least through implantation for females.
Collect and evaluate data through two or more generations.
|
Not required if repeated dose toxicity studies including evaluation of male and female reproductive organs have been done.
Complete all female reproductive toxicity and genotoxicity studies prior to Phase I/II studies. Pre- and postnatal development study prior to marketing approval.
Complete prior to pediatric studies
|
Phase I/II (males, and females
not of child-bearing potential)
Phase I/II (pregnant females and females of childbearing potential)
Pediatric clinical trials
|
Carcinogenicity studies
|
Variable
|
Prior to long-term pediatric trials. Not usually needed unless there is cause for concern.
|
Pediatric clinical trials
|
Juvenile animal safety studies
|
Variable
|
When previous safety data are insufficient
|
Pediatric clinical trials
|
Supplementary toxicity studies
|
Variable; dependent on previous toxicity studies
|
Required if previous findings indicate special concerns
|
|
|
Download printable version of our booklet Preclinical Toxicology – Points to Consider in Program Design (PDF).