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Neonatal and juvenile toxicology

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:

  • Oral and subcutaneous: Day 4
  • Intravenous: Day 21
  • Oral and subcutaneous: Day 7 / 10-12 weeks
  • Intravenous: Day 7 / 10-12 weeks
  • Intratracheal: Day 7
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Therapeutic areas

Cardiology

Neurology

Pneumology

Oncology

Immuno-oncology

Allergy

Dermatology

Gastro-enterology

Analgesia/inflammation

Endocrinology

Haematology

Nephrology

A comprehensive range of preclinical models for short and long-term toxicology studies

Our animal models

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Mouse

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Rat

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Dog

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Rabbit

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Marmoset

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Ferret

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Cynomolgus Monkeys

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Guinea Pig

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Cat

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Hamster

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MiniPig

A wide range of services that span the entire drug discovery and development continuum and can be tailored to specific research conditions

Our Services

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UNIQUE PROJECT

Each project is managed by a study director, relying on a multi-disciplinary team of experts.