The 19 references in paper N. Neugodova P., M. Ryabtseva S., G. Sapozhnikova A., Н. Неугодова П., М. Рябцева С., Г. Сапожникова А. (2018) “Основные требования к биологическим показателям при оценке качества лекарственных средств. Возможности валидации биологических методов контроля // Basic requirements for biological criteria in drug quality evaluation. validation of biological control methods” / spz:neicon:vedomostincesmp:y:2016:i:3:p:3-8

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Yurgel NV, Kosenko VV, Davydova KS, Budanov SV, Bagirova VL, Kovaleva EL, et al. Rules of compilation, presentation and design quality standards for pharmaceutical substances. Guidelines. Moscow; 2009 (in Russian).
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State register of medicines. V. II, parts 1 and 2. Moscow: Official publication; 2009 (in Russian).
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Shapovalova OV, Dolgova GV, Neugodova NP. Features of the development of section «Bacterial endotoxins» for antibiotic substances. Antibiotiki i himioterapiya 2008; 53(11–12): 34–58 (in Russian).
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Shapovalova OV, Dolgova GV, Neugodova NP, Sapozhnikova GA. Methodological approaches to the elaboration of «Bacterial endotoxins» index in the pharmaceutical substances. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2012; (2): 47–50 (in Russian).
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6
Shapovalova OV, Dolgova GV, Neugodova NP, Sapozhnikova GA. The use of organic solvents to determine of «Bacterial endotoxins» index in the water-insoluble pharmaceutical substances. Antibiotiki i himioterapiya 2013; (9): 41–4 (in Russian).
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7
Merkulova YuV, Dolgova GV, Neugodova NP, Chayka LA, Gomon ON, Shapovalova OV. Properties of the test to bacterial endotoxins of medicines in the form of oily solutions. Farmakom 2008; (1): 67–73 (in Russian).
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Pershin GN. Methods of experimental chemotherapy. Moscow: Meditsina; 1971 (in Russian).
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Krylov YuF, Kivman GYa. Biological control of drug safety. Moscow: Meditsina; 1985 (in Russian).
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Neugodova NP, Dolgova GV, Hayretdinova MN, Pomerantseva TYa, Sapozhnikova GA, Verstakova OL. The procedure of the implementation of pharmaceutical index «Abnormal Toxicity» by the example of antibiotics. Antibiotiki i himioterapiya 2008; 53(7–8): 19–26 (in Russian).
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11
Neugodova NP, Dolgova GV, Sapozhnikova GA, Lutseva AI. Approaches to the assessment of biosimilars safety. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2013; (3): 32–4 (in Russian).
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Sharoykina MV, Kovaleva EL, Neugodova NP. Methodical approaches to the estimation of abnormal toxicity cephalosporin antibiotics. Sechenovskiy vestnik 2014;16(2): 111 (in Russian).
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Neugodova NP, Dolgova GV, Pomerantseva TYa, Hayretdinova MN, Sapozhnikova GA. Effect of parameter «Injection rate» during the test «The test for toxicity». Antibiotiki i himioterapiya 2009; (1): 53–5 (in Russian).
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14
Sharoykina MV, Ryabtseva MS, Kovaleva EL, Neugodova NP. Effect of parameter «Injection rate» during the test «Abnormal Toxicity» to ensure the quality of the antibiotic cephalosporin group — ceftriaxone. Antibiotiki i himioterapiya 2015; (1–2): 35–8 (in Russian).
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Karkischenko NN, Grachev SV. Guide to laboratory animals and alternative models in biomedical research. Moscow: Profile–2C; 2010 (in Russian).
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The Triptofan Incident. European Federation of Biotechnology. Fact Sheet 1. Available from: http:// www.quackwatch.com/01QuackeryRelatedTopics/DSH/trypto.html.
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U. S. Food and Drug Administration. Available from: http://www.fda. gov/default.htm.
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18
Garbe YHO, Osborne C, Beggs K, Bopst M, Jos A, Kitashova AA, et al. Exclusion of test for abnormal toxicity as a quality control test: a historical analysis of the data and scientific knowledge. Razrabotka i registratsiya lekarstvennyh sredstv 2015;2(11): 184–92 (in Russian).
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19
Karkischenko NN. Alternatives of biomedicine. Moscow: Mezhakademicheskoe izdatelstvo VPK; 2010 (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, Petrovsky boulevard 8, bld. 2, Moscow 127051, Russian Federation.
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