The following table outlines the typical duration for various types of preclinical studies and the preferred timing relative to clinical trials they support.
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Pre/Nonclinical Study
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Duration
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Time
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Clinical Study Supported
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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
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Prior to Phase I. Information should be available by the time early Phase I trials are completed. |
Phase I/II
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Repeated dose toxicity studies in one rodent and one non-rodent model
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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
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Prior to Phase I
Prior to Phase III
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Phase I/II:
2 weeks to
12 months
Phase III:
< 2 weeks
< 1 month
> 1 month
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|
Genotoxicity studies
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Variable
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Complete prior to start of Phase II and all pediatric clinical trials
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Phase I/II
Pediatric clinical trials
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Reproductive toxicity studies
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(> 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.
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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
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Phase I/II (males, and females
not of child-bearing potential)
Phase I/II (pregnant females and females of childbearing potential)
Pediatric clinical trials
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Carcinogenicity studies
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Variable
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Prior to long-term pediatric trials. Not usually needed unless there is cause for concern.
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Pediatric clinical trials
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Juvenile animal safety studies
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Variable
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When previous safety data are insufficient
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Pediatric clinical trials
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Supplementary toxicity studies
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Variable; dependent on previous toxicity studies
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Required if previous findings indicate special concerns
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Download printable version of our booklet Preclinical Toxicology – Points to Consider in Program Design (PDF).
