Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2549369 | Journal of Pharmacological and Toxicological Methods | 2012 | 9 Pages |
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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Authors
Yuansheng Sun, Marion Gruber, Mineo Matsumoto,