Overview of global regulatory toxicology requirements for vaccines and adjuvants

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• 作者：Yuansheng Sun^a ; ^sunyu@pei.de ; Marion Gruber^b ; ¹ ; ^{marion.gruber@FDA.hhs.gov} ; Mineo Matsumoto^c ; ² ; ^{matsumoto-mineo@pmda.go.jp}
• 关键词：Vaccine ; Adjuvant ; Toxicology ; Nonclinical ; Safety assessment
• 刊名：Journal of Pharmacological and Toxicological Methods
• 出版年：2012
• 期刊代码：28_10568719
• 类别：pha
• 出版时间：March-April, 2012
• 卷：65
• 期：2
• 页码：49-57
• 文件大小：395 K

摘要

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.