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Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development
Published on: June 19, 2018
Overview of global regulatory toxicology requirements for vaccines and adjuvants
Yuansheng Sun1, Marion Gruber, Mineo Matsumoto
1Paul-Ehrlich Institute, Langen, Germany. sunyu@pei.de
Abstract:
This paper provides an overview of the legislations and regulatory approaches currently applied to the nonclinical safety assessment of human preventive vaccine products in three ICH regions, i.e., the EU, USA, and Japan. Perspectives of the three regions with regard to the various types of toxicity studies currently considered to assess the nonclinical safety of preventive vaccines are compared and described in more detail than in published guidelines. In addition, the common issues and current challenges in nonclinical safety assessment of preventive vaccines are discussed.
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