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Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label
11 Visiting Professor, The Lincoln School of Pharmacy, University of Lincoln, Lincoln, UK.
Therapeutic Innovation & Regulatory Science
|May 2, 2018
Summary
Juvenile animal testing is standard in drug development for pediatric use. Current general toxicology designs may not fully inform safe prescribing, prompting a need for more focused studies.
Area of Science:
- Pharmacology and Toxicology
- Pediatric Drug Development
Background:
- Juvenile animal testing is a standard practice in drug development.
- It aims to ensure the safe clinical use of medications in the pediatric population.
- Data from these studies are intended for drug product labeling.
Purpose of the Study:
- To review the characteristics of juvenile animal studies requested in European Paediatric Investigation Plans.
- To evaluate the utility of existing juvenile animal testing designs for pediatric drug development.
- To identify areas for improvement in juvenile animal study protocols and data interpretation.
Main Methods:
- Analysis of European Paediatric Investigation Plan decisions from 2007 to mid-2017.
- Review of requested juvenile animal studies, including species, therapeutic areas, and study designs.
- Examination of how juvenile animal study findings are presented in drug product labels.
Main Results:
- 229 drugs required juvenile animal studies, predominantly using general toxicology designs in rats.
- Infectious diseases, endocrinology, oncology, neurology, and cardiovascular diseases were common therapeutic areas.
- The usefulness of presented data for prescribing decisions in children was questioned.
Conclusions:
- The upcoming ICH S11 guideline is expected to clarify the necessity of juvenile animal studies.
- It may encourage a shift from conventional toxicology designs to more focused testing.
- Improved study designs and data interpretation are needed for better risk assessment by prescribers.
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