The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) enacted in the US in 2002 and 2003, respectively, and later mirrored in Europe, have driven a significant increase in the number of drugs with pediatric labeling and a growing interest in juvenile toxicology. This field of study presents many challenges, the first being that children are not small adults, but instead individuals going through multiple life stages, from neonatal, to early and late infantile, juvenile, and peripubertal stage.
ERBC has extensive experience in conducting neonatal and juvenile toxicity studies. Performed in accordance with FDA and EMA requirements, these programs often include toxicokinetic studies.
Single and repeated dose toxicity study
- Species: rat, minipig, dog
- Administration routes: oral, intravenous, subcutaneous
Earliest day of dosing:
in Rat
- Oral and subcutaneous: Day 4
- Intravenous: Day 21
in Minipig / Dog
- Oral and subcutaneous: Day 7 / 10-12 weeks
- Intravenous: Day 7 / 10-12 weeks
- Intratracheal: Day 7
