This is a note for guidance on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing.
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EU Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/465/95).
Published by The European Agency for the Evaluation of Medicinal Products, EMA
EMAGuidelineVaccineToxicityAnimal ModelsPreclinical Testing