Мақаланы E-mail арқылы жіберу PRE-CLINICAL SAFETY EVALUATION OF PREPARATIONS CONTAINING A COMBINATION OF KNOWN DRUGS
- Авторлар: Syubaev R.D.1, Nemkova I.N.1, Engalycheva G.N.1, Guskova T.A.2, Vasiliev A.N.1
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Мекемелер:
- Federal State Budgetary Institution «Scientific Center of Medical Application Products» of the Ministry of Health of the Russian Federation
- Non-commercial partnership of healthcare assistance «Scientific centre of quality control»
- Шығарылым: № 5 (2014)
- Беттер: 2-7
- Бөлім: Articles
- ##submission.datePublished##: 10.10.2014
- URL: https://rjsvd.com/0869-7922/article/view/641378
- DOI: https://doi.org/10.15690/vramn556
- ID: 641378
Дәйексөз келтіру
Толық мәтін
Аннотация
А program of investigational studies of new combined preparations containing known medications includes investigation into general toxic effect of a combination but does not plan investigations into toxicity of its active components. The medical application of these medications assumes that pre-clinical and clinical data proving their effectiveness and safety are sufficient. But a fragmentary and controversial nature of data about toxicity of drugs available to those involved in new drug development significantly restricts the use of literature data in characterizing a combination toxicity expected profile, predicting and identifying the interaction effects. A prognostic and experimental evaluation of active components toxicological interaction was performed using the example of the metamizole sodium and ibuprofen fixed combination. The adequacy evaluation of the program of investigational studies and interpretation results of the combined preparation toxicological assessment was carried out using a common analytical practice.
Авторлар туралы
Rashid Syubaev
Federal State Budgetary Institution «Scientific Center of Medical Application Products» of the Ministry of Health of the Russian Federation
Хат алмасуға жауапты Автор.
Email: noemail@neicon.ru
Доктор медицинских наук, начальник управления экспертизы лекарственных средств №4 Центра экспертизы и контроля готовых лекарственных средств ФГБУ «НЦЭСМП» Министерства здравоохранения Российской Федерации, 127051, г. Москва
e-mail: Subaev@expmed.ru
РесейIrina Nemkova
Federal State Budgetary Institution «Scientific Center of Medical Application Products» of the Ministry of Health of the Russian Federation
Email: noemail@neicon.ru
Эксперт первой категории управления экспертизы лекарственных средств №1 Центра экспертизы и контроля готовых лекарственных средств ФГБУ «НЦЭСМП» Министерства здравоохранения Российской Федерации, 127051, г. Москва
e-mail: Nemkova@expmed.ru
РесейGalina Engalycheva
Federal State Budgetary Institution «Scientific Center of Medical Application Products» of the Ministry of Health of the Russian Federation
Email: noemail@neicon.ru
Кандидат биологических наук, ведущий эксперт управления экспертизы лекарственных средств №3 Центра экспертизы и контроля готовых лекарственных средств ФГБУ «НЦЭСМП» Министерства здравоохранения Российской Федерации, 127051, г. Москва
e-mail: Engalycheva@expmed.ru
РесейTatyana Guskova
Non-commercial partnership of healthcare assistance «Scientific centre of quality control»
Email: noemail@neicon.ru
Член-корреспондент РАМН, заслуженный деятель науки Российской федерации, доктор медицинских наук, профессор, руководитель отдела оценки эффективности и безопасности лекарственных средств НП СЗ «Научный центр контроля качества», 109074, г. Москва
e-mail: tagus@rambler.ru
РесейAndrey Vasiliev
Federal State Budgetary Institution «Scientific Center of Medical Application Products» of the Ministry of Health of the Russian Federation
Email: noemail@neicon.ru
Доктор биологических наук, директор Центра экспертизы и контроля готовых лекарственных средств ФГБУ «НЦЭСМП» Министерства здравоохранения Российской Федерации, 127051, г. Москва
e-mail: Vasilev@expmed.ru
РесейӘдебиет тізімі
- Guskova T.A., Syubaev R.D. Combinatorial factors influence the reliability of the theoretical prediction of toxicological effects of multi-component interaction. Toksikologicheskij vestnik. 2003, 4: 2-11 (in Russian).
- Guskova T.A., Syubaev R.D. Toxicological aspects of the simultaneous use of different drugs. In: Guskova T.A. Toxicology of drugs. Moscow: Russkij vrach Publ.; 2003:116-40 (in Russian).
- Syubaev R.D., Engalycheva G.N. Preclinical safety assessment of drug interactions. Lekarstvennye sredstva. 2011, 3: 39-44 (in Russian).
- Toxnet (data base). Available at: http://toxnet.nlm.nih.gov (accessed 17April 2014).
- DrugBank (data base). Available at: http://www.drugbank.ca (accessed 11 February 2014).
- State register of medicines. Available at: http:://grls.rosminzdrav.ru (accessed 26 March 2014).
- Chuchalin A.G., Jasnecov V.V., eds. Federal guidelines on the use of drugs (formulary system). 15th ed. Moscow: Jeho, 2014 (in Russian).
- Mironov A.N., ed. in ch. Guidelines for pre-clinical trials of drugs. part 1. Moscow: Grif i K, 2012 (in Russian).
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