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Value of juvenile animal studies
Isabelle Leconte1, Graham Bailey, Karen Davis-Bruno
1Sanofi-Aventis Research and Development, Porcheville, France.
Insights
Well-designed juvenile animal studies are valuable for pediatric drug development, but not always necessary. This finding emerged from a workshop assessing their impact on drug safety and risk assessment.
Area of Science:
- Toxicology
- Pharmacology
- Pediatric Drug Development
Background:
- The ILSI Health and Environmental Sciences Institute's Developmental and Reproductive Toxicology Technical Committee initiated a project on juvenile animal studies.
- A global survey was conducted to gather data on the use and impact of these studies.
Purpose of the Study:
- To discuss the impact of juvenile animal studies on pediatric drug development.
- To evaluate survey data on the use and impact of juvenile studies in labeling and risk assessment.
- To identify improvements for juvenile animal study designs.
Main Methods:
- A workshop was held with scientists from industry, academia, and regulatory agencies.
- Summary data from a 2009-2010 global survey were presented.
- Breakout sessions discussed specific case studies.
Main Results:
- Well-designed juvenile animal studies have shown value in supporting specific pediatric drug development programs.
- Juvenile animal studies are not universally required for all pediatric drug development.
- Data usage in labeling and risk assessment was evaluated.
Conclusions:
- Juvenile animal studies can provide essential data for pediatric drug safety.
- The necessity of juvenile animal studies should be carefully considered on a case-by-case basis.
- Further improvements in study design are needed.
Abstract:
The Developmental and Reproductive Toxicology Technical Committee of the ILSI Health and Environmental Sciences Institute has undertaken a project to address the impact of juvenile animal studies on pediatric drug development. A workshop, sponsored and organized by the Health and Environmental Sciences Institute Developmental and Reproductive Toxicity Technical Committee, was held on May 5-6, 2010, in Washington, DC, to discuss the outcome of a global survey and the value of juvenile animal studies in the development of drugs intended for use in pediatric patients. During this workshop, summary data from the 2009-2010 survey were presented, and breakout sessions were used to discuss specific case studies to try to assess the impact of juvenile animal studies performed to support specific pediatric drug development. The objectives of the Workshop on The Value of Juvenile Animal Studies were to (1) provide a forum for scientists representing industry, academia, and regulatory agencies to discuss the impact of juvenile animal studies on pediatric drug development, (2) evaluate summary data from the survey to understand how the juvenile study data are being used and their impact in labeling and risk assessment, (3) discuss selected case studies from the survey to highlight key findings, and (4) identify the areas of improvement for the designs of juvenile animal studies. The take home message that resonated from the workshop discussions was that well-designed juvenile animal studies have demonstrated value in support of certain pediatric drug development programs. However, it was also clear that a juvenile animal study is not always warranted.
