Overview of global regulatory toxicology requirements for vaccines and adjuvants.
作者： Yuansheng Sun , Marion Gruber , Mineo Matsumoto
DOI: 10.1016/J.VASCN.2012.01.002
关键词:
摘要: This paper provides an overview of the legislations and regulatory approaches currently applied to nonclinical safety assessment human preventive vaccine products in three ICH regions, i.e., EU, USA, Japan. Perspectives regions with regard various types toxicity studies considered assess vaccines are compared described more detail than published guidelines. In addition, common issues current challenges discussed.
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sci-hub.se 参考文章(3)
J VANAMSTERDAM, J TEBIESEBEEK, T VANDEKUIL, J VANDERLAAN, D DEWILDT, W VLEEMING, Repeated administration of whole-cell and acellular pertussis vaccines affects haemodynamics and autonomic responsiveness. Vaccine. ,vol. 16, pp. 1668- 1674 ,(1998) , 10.1016/S0264-410X(98)00058-9
Dick J. De Wildt, Johan G. Kreeftenberg, Frans P. Nijkamp, Severe impairment of cholinergic and adrenergic responsiveness in Bordetella pertussis vaccinated rats European Journal of Pharmacology. ,vol. 86, pp. 315- 316 ,(1982) , 10.1016/0014-2999(82)90337-5
李伟, 白玉, 李波, Guideline on Adjuvants in Vaccines for Human Use Int J Biologicals. ,vol. 30, pp. 182- 184 ,(2007) , 10.3760/CMA.J.ISSN.1673-4211.2007.04.012