DEVELOPMENT OF NATIONAL REQUIREMENTS FOR NONCLINICAL EVALUATION OF HUMAN PAPILLOMAVIRUS VACCINES AS AN IMPORTANT TASK IN THE REGULATION OF DOMESTIC VACCINES RESEARCH
- Authors: Nikitina T.N.1, Zhuk I.E.1, Gorenkov D.V.1, Klimov V.I.1
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Affiliations:
- The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
- Issue: Vol 22, No 4 (2019)
- Pages: 1517-1519
- Section: ORIGINAL ARTICLES
- URL: https://journal-vniispk.ru/1028-7221/article/view/119657
- DOI: https://doi.org/10.31857/S102872210007075-7
- ID: 119657
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Abstract
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.
Keywords
About the authors
T. N. Nikitina
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Author for correspondence.
Email: nikitina@expmed.ru
PhD, Main Expert,
Moscow
Russian FederationI. E. Zhuk
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Leading Expert,
Moscow
Russian FederationD. V. Gorenkov
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Category 1 Expert,
Moscow
Russian FederationV. I. Klimov
The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
PhD, Deputy Director of Centre for Planning and Coordination of Scientifi c Activities,
Moscow
Russian FederationReferences
- 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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