DEVELOPMENT OF NATIONAL REQUIREMENTS FOR NONCLINICAL EVALUATION OF HUMAN PAPILLOMAVIRUS VACCINES AS AN IMPORTANT TASK IN THE REGULATION OF DOMESTIC VACCINES RESEARCH
- 作者: Nikitina T.N.1, Zhuk I.E.1, Gorenkov D.V.1, Klimov V.I.1
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隶属关系:
- The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
- 期: 卷 22, 编号 4 (2019)
- 页面: 1517-1519
- 栏目: ORIGINAL ARTICLES
- URL: https://ogarev-online.ru/1028-7221/article/view/119657
- DOI: https://doi.org/10.31857/S102872210007075-7
- ID: 119657
如何引用文章
全文:
详细
Cervical cancer caused by human papillomavirus is the second most common cancer in women. The development of domestic HPV vaccines is an important aspect of the national and biological security of the population. Nonclinical evaluation is one of the stages in national HPV vaccines development process and should reflect the full range of safety requirements and be harmonized with the requirements of leading international agencies.
作者简介
T. Nikitina
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
编辑信件的主要联系方式.
Email: nikitina@expmed.ru
PhD, Main Expert,
Moscow
俄罗斯联邦I. Zhuk
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Email: fake@neicon.ru
Leading Expert,
Moscow
俄罗斯联邦D. Gorenkov
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Email: fake@neicon.ru
Category 1 Expert,
Moscow
俄罗斯联邦V. Klimov
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Email: fake@neicon.ru
PhD, Deputy Director of Centre for Planning and Coordination of Scientifi c Activities,
Moscow
俄罗斯联邦参考
- World Health Organization. Human papillomavirus (HPV) and cervical cancer. Key facts. 2019 Jan 24, 2019. Retrieved from: https://www.who.int/en/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-andcervical-cancer, accessed 04 Feb 2019.
- Руководство по проведению доклинических исследований лекарственных средств (Иммунобиологические лекарственные препараты). Часть вторая / под ред. А. Н. Миронова. – М.: Гриф и К, 2013. – 536 с.
- Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines. In: WHO Expert Committee on Biological Standardization: sixty-fourth report. Geneva: World Health Organization; 2014: Annex 2; WHO Technical Report Series, 987. Retrieved from: http://apps.who.int/iris/bitstream/10665/129494/1/TRS_987_eng.pdf?ua=1&ua=1, accessed 04 Feb 2019).
- WHO guidelines on nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization: fifty-fourth report. Geneva: World Health Organization; 2005: Annex 1; WHO Technical Report Series, No. 927. Retrieved from: http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31–63.pdf?ua=1, accessed 04 Feb 2019).
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