1 Общая литература
[1] | U.S./EPA РВ 86/108958 and 89/124077 |
[2] | U.S./FDA Toxicological principles for the safety assessment of direct food additives, 1982 |
[3] | U.S. Code of Federal Regulation 1500.40: Method of Testing Toxic Substances |
[4] | United States Pharmacopoeia 26: Biological Reactivity Tests, In Vivo; The National Formulary 21, Rockville, MD; Pharmacopoeial Convention, 2003, pp. 2028-2032 |
[5] | ASTM F619-03, Standard Practice for Extraction of Medical Plastics |
[6] | SN 119800:1990, Biological Evaluation of Dental Materials |
[7] | European Pharmacopoeia 4th Edition, 2002 |
[8] | MHLW Notification No. 0213001(2003.02.13): Principles for Biological Safety Evaluation of Medical Devices |
[9] | HALLE, W. (2003) The Registry of Cytotoxicity: Toxicity testing in cell cultures to predict acute toxicity (LD50) and to reduce animal testing, ATLA 31:89-98 |
2 Библиография по объему доз
[10] | HULL, R.M. Guideline limit volumes for dosing animals in the preclinical stage of safety evaluation, Human and Environmental Toxicology, 1995, 14, pp.305-307 |
[11] | DERELANKO, M.J. and HOLLINGER, M.A. CRC Handbook of Toxicology, CRC Press, NY, 2nd edition, 2001, p.98 |
[12] | DIEHL, K.-H. et al. A good practice guide to the administration of substances and removal of blood, including routes and volumes, J. Applied Toxicology, 21, 2001, pp.15-23 |
[13] | MORTON, D. et al. Effects of infusion rates in rats receiving repeated large volumes of intravenous saline solution, Laboratory Animal Sciences, 47, 1997, pp.656-659 |
[14] | RICHMOND, J.D. Dose limit volumes: The United Kingdom view - past and present. Presented at the Humane Society of the United States - Refinement in Toxicology Testing: Dosing Data: Volume and Frequency, March 14, 1999, New Orleans, LA |
[15] | MORTON, D.B. et al. Refining procedures for the administration of substances. Report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement, Laboratory Animals, 35, 2001, pp.1-41 |
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УДК 615.46:002:006.354 МКС 11.100.20 Р20 IDT
Ключевые слова: медицинские изделия, лабораторные животные, испытания на животных, токсичность, пирогенность, эндотоксины, доза
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М.: Стандартинформ, 2014