The 8 references in paper O. Ustinnikova B., O. Runova B., E. Velichko V., Ольга Устинникова Борисовна, Ольга Рунова Борисовна, Елена Величко Викторовна (2018) “Рекомендации к составлению нормативной документации на иммунобиологические лекарственные препараты в части физико-химических показателей качества // Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics” / spz:neicon:vedomostincesmp:y:2015:i:3:p:8-12

1
Federal'nyj zakon No 61-FZ ot 12 aprelja 2010 g. «Ob obrashhenii lekarstvennyh sredstv» (in Russian).
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2
State Standard GOST R ISO 5725-1-2002. Accuracy (trueness and precision) of measurement methods and results. Part 1: Basic terms and definitions. Moscow: Gosstandart Rossii; 2002. P. 24 (in Russian).
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3
State Standard GOST ISO/MJeK 17025-2009. General requirements for the competence of testing and calibration laboratories. Moscow: Gosstandart Rossii; 2009 (in Russian).
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4
Guideline PA/PH/OMCL (13) 113 R Evaluation and reporting of results.
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5
MI 2881-2004 Rekomendacija. GSOEI. The techniques of quantitative chemical analysis. Procedures for verifying the acceptability of the results of the analysis. Moscow; 2004 (in Russian).
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6
Mironov AN, ed. Manual on expertise of medicines. V. II. Moscow: Grif i K; 2013. 280 p. (in Russian). R E F E R E N C E S Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8 Petrovsky Boulevard, Moscow, 127051, Russian Federation. Ustinnikova OB. Head of Laboratory of Biochemistry of medical immunobiological preparations of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences. Runova OB. Leading expert of Laboratory of Biochemistry of medical immunobiological preparations of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Chemical Sciences. Velichko EV. Senior te
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7
The State Pharmacopoeia of Russian Federation, 12th ed., V. 1. Moscow: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation; 2008 (in Russian).
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8
European Parmacopoeia 8.1 04/2014, 2.2.29 Liquid chromatography, 2.2.30 Size-exclusion chromatography, 2.2.46 Chromatographic separation techniques. 7. Государственная фармакопея Российской Федерации. 12-е изд. Ч. 1. М.: НЦЭСМП; 2008.
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