期刊文献+

人用动物免疫血清制品质量标准的回顾与探讨 被引量:3

Review and Discussion on the Development of the Quality Control of Animal Immunoglobulin and Immunosera for Human Use
下载PDF
导出
摘要 人用动物免疫血清类制品(抗毒素、抗血清)已在临床使用多年,由于这类制品在临床治疗的不可替代性以及在反生物恐怖中的战略意义,近年来受到国内外更多的关注。本文对我国抗毒素、抗血清制品质量标准的发展和完善进行了探讨。 Animal immunoglobulin and immunosera for human use have been used in clinical therapy for many years. Because of their exclusive characteristic in treatment of some infectious diseases and strategic significance in anti-bioterrorism, more attention is now focused on these products. This article discussed on the development of the quality control of animal immunoglobulin and immunosera for human use in china.
作者 郭中平
机构地区 国家药典委员会
出处 《中国药品标准》 CAS 2008年第1期19-23,共5页 Drug Standards of China
  • 相关文献

参考文献6

  • 1[1]Note for guidance on production and quality control of animal im-munoglobulin and mmunosera for human use London,24 June 2002CPMP/BWP/3354/99.
  • 2[2]Guidance for industry (For the submission of chemistry,manufac-turing and control and establishment description information for hu-man plasma-derived biological products,animal plasma or serum-derived products) FDA CBER Feb,1999.
  • 3[3]Workshop on standards for inactivation and clearance of infection agents in the manufacture of plasma derivatives from non-human materials for human injectable use (FDA CBER Oct,1999).
  • 4[4]Basic requirements for viral safety of biotechnological/boiological products listed in Japanese Pharmacopoeia.Supplement I of the Japanese Pharmacopoeia 14th edition:1618-1631.December 27,2002.the MHLW Ministerial notification No 395.
  • 5[5]Qualification of animals as origin of animal-derived medicinal prod-ucts provided in the general notices 39 of Japanese Pharmacopoeia and other standard~Supplement of the Japanese Pharmacopoeia 14th edition:1631-1634.December27,2002,the MHLW Minis-tedal notification,No.395.
  • 6[6]Notefor guidance on Virus validation studies:the design,contri-bution and interpretation of studies validating the insctivation and removal viruses London,14 February,1996,CPMP/BWP/268/ 96.

同被引文献11

引证文献3

二级引证文献1

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部