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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on Adjuvants in Vaccines for Human Use. 2005 (EMEA/CHMP/VEG/134716/2004).

Published by The European Medicines Agency Evaluation of Medicines for Human Use ,

EMAGuidelineVaccineToxicityAnimal ModelsNon-Clinical Testing

This Guideline addresses the quality, non-clinical and clinical issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on a case-by-case basis. 

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications. 2008 (EMEA/CHMP/SWP/169215/2005).

Published by European Medicines Agency (EMA)

EMAGuidelineAnimal ModelsNon-Clinical TestingJuvanile AnimalsPaediatric Indications

This document provides guidance on the need for, role and timing of studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It is applicable to initial medicinal products applications and also to authorised medicinal products being further developed to include paediatric indications. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials. 

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