The 15 references in paper M. Ryabtseva S., T. Batuashvili A., G. Sapozhnikova A., N. Neugodova P., Yu. Olefir V., V. Merkulov A., М. Рябцева С., Т. Батуашвили А., Г. Сапожникова А., Н. Неугодова П., Ю. Олефир В., В. Меркулов А. (2018) “История развития и современное состояние биологических тестов в России // History and current status of biological tests in Russia” / spz:neicon:vedomostincesmp:y:2016:i:1:p:11-14

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Schechtman LM. The Safety Assessment Process — Setting the Scene: An FDA Perspective. ILARJ 2002; 43(Suppl 1): S5–S10. Available from: http:// ilarjournal.oxfordjournals.org/.
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History of Federal Regulation: 1902–Present. Available from: http:// www.fdareview.org/history.shtml.
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Krylov YuF, Kivman GYa. Biological control of drug safety. Moscow: Meditsina; 1985 (in Russian).
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U.S.P. 12th edition. 1942.
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Sitnikov AG, Travina LA, Bagirova VL. LAL test. Modern approaches to the determination of pyrogenicity. Moscow; 1997 (in Russian).
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European Pharmacopoeia. 6th edition. 2010.
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Cussler K. The Scientific Relevance of the ATT — Today and from a historical Perspective. Available from: https://circabc.europa.eu/ sd/a/713b9d43 – 9383 – 4681-a46a-054c6249c40b/ihb%20sept% 202015%205%20Case%20study%201 Klaus%20Cussler.pdf.
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9
Garbe IHO, Osborne C, Beggs K, Bopst M, Jos A, Kitashova AA, et al. The exception 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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10
FDA [Food and Drug Administration]. 1981b. The Story of The Laws Behind The Labels, Part II: 1938 — The Federal Food, Drug, and Cosmetic Act. FDA Consumer, June, 1981. Available from: http:// vm.cfsan.fda.gov/~lrd/historla.html.
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The State Pharmacopoeia of the USSR. 10th ed. Moscow: Meditsina; 1968 (in Russian).
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U.S.P. 21th edition. 1985.
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The State Pharmacopoeia of the Russian Federation. 12th ed. Part 1. Moscow: NCESMP; 2008 (in Russian).
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U.S.P. 22th edition. 1990.
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The State Pharmacopoeia of the Russian Federation. 13th ed. Part 1. Moscow: NCESMP; 2015 (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, 8–2, Moscow, 127051, Russian Federation.
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