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 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