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 | |
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Download printable version of our booklet Preclinical Toxicology – Points to Consider in Program Design (PDF).
