ГОСТ Р ИСО 10993-16—2009
Библиография
(1]ISO 10993-2:1992 Biological evaluation of medical devices — Part 2. Animal welfare requirements
(2]ISO 10993-12:1996 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
(3]Andersen M.E., Clewell H.J. III. Gargas M.L., Smith F.A. and Reitz R.H. Physiologically-based pharmacokinetics and
the nsk assessment process for methylene chloride. Toxicol. Appl. Pharmacol. 54:100— 116. 198?
(4]Bogen D.K. Simulation software for the Macintosh. Science 24: 138— 142; 1989
(5] F.D.A. Guidelines for the format and content of the human pharmacokinetics and bloavallabillty section of an
application. Department of Health and Human Services
(6] Hattis D., White P.. Mamorsteln L. and Koch P. Uncertainties in pharmacokinetic modelling for perchloroethylene. I.
Comparison of model structure, parameters and predictions for low-dose metabolism rates derived by different
authors. Risk analysis 10: 449—458. 1990
(7] Intemattnal Programme on Chemical Safety (IPCS). Principles of toxicoklnetic studies. Environmental Health Criteria
57. World Health Organization. Geneva. 1986
(8] ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to
biological testing
(9JJollow D.J., Roberts S.. Pnce V.. Longacre S. and Smith C. Pharmacokinetic considerations in toxicity testing. Drug
Metab. Rev. 13: 983— 1007. 1982
(10] Katzper M. The uze of visual programming for pharmacokinetic and pharmacodynamic simulation. Centre for Drug
Evaluation and Research. FDA, 5600 Fishers Lane. Rockville MD 20857
(11] Lin C.S.. ShoafS.E.and Gnffiths J.C. Pharmacokinetic data In the evaluation of the safety of food and colour additives.
Reg. Toxicol. Pharmacol. 15: 62—72. 1992
(12] Monro A M. Interspecies comparisons in toxicology. The utility and futility of plasma concentrations of the test
substance. Reg. Toxicol. Pharmacol 12: 137— 160. 1990
(13] Organization for Economic Cooperation and Development (OECD). Guidelines for testing of chemicals — No 417
Toxicokinetics. OECD Publications
(14] Reitz R. Distribution. Persistence and elimination of toxic agents. In: Progress In Predictive Toxicology. Clayson D В et
al. (eds.). Elsevier. New York. 1990
(15] Rowland M. and Tozer T.N. Clinical pharmacokinetics: concepts and applications (2я0 edition). Lea and Febiger.
Philadelphia. 1989
(16] Smith D.A.. Humphrey M.J. and Charnel C. Design of toxicoklnetic studies. Xenobiotica 20: 1187—1199. 1990
(17] Speld L.H.. Lumley C.E. and Walker S.R. Harmonisation of guidelines for toxicity testing of pharmaceuticals by 1992.
Reg. Toxicol. Pharmacol. 12: 179—211.1990
(18] Travis C.B. Pharmacokinetics. In: Carcinogen Risk Analysis. Travis C.B. (ed) Contemporary issues in nsk analysis,
vol. 3. Plenum Press. New York. 1988
(19] Wagner J.G. Pharmacokinetics for pharmaceutical scientists. Technomic publishing Co. Inc.. Lancaster. 1994
(20] Wartak J. Clinical Pharmacokinetics. A modern approach to individualised drug therapy. Clinical Pharmacology and
Therapeutics Senes. Vol. 2. Praeger Publishers CBS Educational and Professional Publishing. 1983
(21] Weissmger J. Nonclmlcal pharmacologic and toxicologic considerations for evaluating biologic products. Reg. Toxicol.
Pharmacol. 10: 255—263. 1989
(22] Welling P.G. Pharmacokinetic processes and mathematics. ACS Monograph 185. American Chemical Society.
Washington DC. 1986
(23] Welling P.G.. De La Iglesia F.A. Drug toxicokinetics. Marcel Dekker. Inc. New York, 1993
(24] Yacobi A.. Skelly J.P. and Batra V.K. Toxicokinetics and new drug development. Pergamon Press. 1989
8