Neonatal and Juvenile Toxicology Testing
When evaluating pharmaceuticals and biologic drugs (including vaccines) indicated for pediatric use, it’s important to remember that children are not merely small adults; your study design must consider the specific differences between the pediatric and adult populations. Having successfully supported registration of these types of products for decades, our team of experts ensures that our neonatal and juvenile toxicology studies assess specific developmental milestones from birth to adulthood.
We’ve conducted hundreds of rodent studies and over 50 nonrodent studies in neonatal and juvenile models, using a comprehensive range of dose routes. Our developmental and reproductive toxicology experts can advise, design and execute your best testing strategy according to the needs of your specific therapeutic, even additives to baby formula.
Juvenile and Neonatal Toxicology
Study Design Considerations
- Intended population or likely use of the drug in children
- Species selection, age, sex, and sample size
- Novel pediatric formulations
- Timing of dosing, exposure, and monitoring in relation to phase of growth and development in pediatric populations and juvenile animals
- Potential differences in pharmacological and toxicological profiles between mature and immature systems
- Selection of toxicological and organ system endpoints
- Nervous system
- Immune system
- Other organ systems (renal, cardiovascular, gastrointestinal, pulmonary)
- Reproductive system
- Skeletal system (growth)
- Routine toxicology endpoints (e.g., clinical pathology, metabolic system, histopathology)
- Juvenile safety pharmacology (neurobehavioral, pulmonary, cardiovascular)
Our study designs include the evaluation of specialty toxicology endpoints and organ systems of concern which are considered relevant to juvenile toxicity testing.
Frequently Asked Questions (FAQs) about Neonatal and Juvenile Toxicology
What is required for a standard neonatal toxicology study?
Each study must be designed on a case by case basis, considering the specific developmental milestones and organ systems of concern when designing a neonatal toxicology study.