Gathering safety data
Juvenile Toxicology | KinderPharm
Juvenile toxicology studies are conducted for several reasons. These include when:
- Pediatric safety concerns cannot be addressed in conventional toxicology studies in adult animals
- Existing data humans are inadequate to support the proposed clinical trial in children
- Safety concerns cannot be safely, ethically or adequately addressed in pediatric patients (e.g irreversible effects).
There are a number of important factors that need to be considered as part of the design and conduct of juvenile toxicology studies. These include the proposed pediatric indication, the age of the intended population, the extent and timing of drug exposure, the likely target organ(s) for toxicity, if the target organ(s) undergo significant post natal development.
Other important factors to be considered in the study design include the selection of the appropriate dose range, dosing regimen and route of administration, the characterization of acute vs permanent (irreversible) effects and the selection of relevant species for the evaluation of small molecules and biologics (antibodies, vaccines, proteins etc).
KinderPharm’s pediatric toxicologists can evaluate your existing safety data, identify any gaps in existing pre-clinical safety studies and design the appropriate safety and juvenile toxicology studies to support the clinical development of your drug in children.
KinderPharm’s toxicologists and project managers closely plan, coordinate, and monitor the in-life phase, data analysis and reporting activities so that projects are conducted to the highest quality, on time and within budget.
Contact us about your and juvenile toxicology and pediatric safety assessment needs.