Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals?
Abstract
:1. Introduction
2. When to Call Toxicity Studies in Juvenile Animals?
- Guidelines for use of excipients (FDA, CHMP, ICH);
- Position and Opinion papers (e.g., CHMP);
- Regulations on food, food additives and flavoring (e.g., European Food Safety Scientific Assessments (EFSA), Joint Expert committee on food additives (JECFA): US FDA GRAS list);
3. Conclusions
Acknowledgments
Conflicts of Interest
References
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Schmitt, G. Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals? Children 2015, 2, 191-197. https://doi.org/10.3390/children2020191
Schmitt G. Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals? Children. 2015; 2(2):191-197. https://doi.org/10.3390/children2020191
Chicago/Turabian StyleSchmitt, Georg. 2015. "Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals?" Children 2, no. 2: 191-197. https://doi.org/10.3390/children2020191