The 13 references in paper G. Engalycheva N., R. Syubaev D., D. Goryachev V., Г. Енгалычева Н., Р. Сюбаев Д., Д. Горячев В. (2018) “Исследования фармакологической безопасности лекарственных средств: экспертная оценка полученных результатов // Safety Pharmacology Studies of Medicinal Products: Evaluation of Results” / spz:neicon:vedomostincesmp:y:2017:i:2:p:92-97

1
Guidance on evaluation of medicines. V. I. Moscow: Grif i K;2013 (in Russian).
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2
Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ 5KYWwR (in Russian).
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3
Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No. 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/ wz7nMH (in Russian).
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4
Order of the Ministry of Health of the Russian Federation of 13.12.2012, No. 1041n «On amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No. 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/Dt7EBm (in Russian).
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5
Safety Pharmacology Studies for Human Pharmaceuticals (S7A) 2000. Available from: https:// goo.gl/h2dG2M.
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6
Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (S7B) 2005. Available from: https:// goo.gl/5W0wSG.
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7
What is Safety Pharmacology? Available from: https:// goo.gl/etRTwe.
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8
State Standard R 56700 – 2015. Medicinal products for human use. Pre-clinical safety pharmacology studies. Moscow: Standartinform; 2016 (in Russian).
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9
Decision of the Council of the Eurasian Economic Commission of 03.11.2016, No. 78 «On rules of registration and evaluation ofmedicinalproductsforhumanuse».Availablefrom: https://goo.gl/s9NsVS (in Russian).
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10
Engalycheva GN, Syubaev RD, Vasiliev AN. Interpretation of class-specific effects in preclinical safety studies of drugs. Sechenovsky vestnik 2016; 2(24): 11–2 (in Russian).
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11
Engalycheva GN, Syubaev RD, Vasiliev AN. Modern requirements to preclinical studies of narcological safety of neurotropic drugs. Obozrenie psihiatrii i meditsinskoy psihologii 2014; Suppl.: 74–5 (in Russian).
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12
Engalycheva GN, Syubaev RD, Vasiliev AN, Snegireva AA, Verstakova OL. Preclinical safety pharmacology evaluation of medicinal products The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2013; (1): 10–3 (in Russian).
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13
Romanov BK, Alyautdin RN, Glagolev SV, Polivanov VA. Typical pharmacovigilance system master file (PSMF). Safety and Risk of Pharmacotherapy 2016; (2): 11–27 (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health
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