ПРИЛОЖЕНИЕ Б
(справочное)
ГОСТ Р ИСО 10993.16-99
Библиография
11] 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 prepararation and reference
materials
|3| Andersen M.E., Clcwell H.J. III. Ciaigas M.L.. Smith F.A. and Reitz R.H. Physiologically-based pharma
cokinetics and the risk assessment process for methylene chloride. Toxicol. Appl. Pharmacol. 54: 100—116: 1987
|4J 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 bioavuilability section of
an application. Department of Health and Human Services
16} Hattis D.. White P., Mamorstcin L. and Koch P. Uncertainties in pharmacokinetic modelling for pcrchlo-
rocthylenc. I. Comparison of model structure, parameters and predictions for low-dose metabolism rates derived by
different authors. Risk analysis 10: 449—458, 1990
|7| Inicmatinal Programme on Chemical Safety(IPCS). Principles oftoxicokinctic 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
|9) Jollow DJ., Roberts S.. PriceV., Longacrc S. and Smith C. Pharmacokinetic considerations intoxicitytesting.
Drug Metab. Rev. 13: 983-1007. 1982
|10| Katzper M. The uzc of visual programming for pharmacokinetic and pharmacodynamic simulation. Centre
for Drug Evaluation and Research. FDA. 5600 Fishers Lane. Rockville MD 20857
1111 Lin C.S., Shoaf S.E. and Griffiths J.C. Pharmacokinetic data in the evaluation of the safety of food and
colour additives. Reg. Toxicol. Pharmacol. 15: 62—72. 1992
112] Monro A.M. Intcrspccies comparisons in toxicology: The utilit and futility of plasma concentrations of the
test substance. Reg. Toxicol. Pharmacol. 12: 137—160, 1990
113| Organization for Economic Cooperation and Development (OECD). Guidelines for testing ofchemicals —
No 417 Toxicokinetics. OECD Publications
|14| Reitz R. Distribution. Persistence and elimination of toxic agents. In: Progress in Predictive Toxicology.
Clayson D В ct al. (cds.), Elsevier. New York. 1990
|15| Rowland M. and Tozer T.N. Clinical phannacokinetiks: concepts and applications (2nd edition). Lea and
Febiger, Philadelphia. 1989
116| Smith D.A.. Humphrey M.J. and Charnel C. Design oftoxicokinctic studies. Xcnobiotica 20: 1187—1199,
1990
117| Speid L.H., LumlcyC.E. and Walker S.R. Harmonisation ofguidelines for toxicity testingofpharmaceuticals
by 1992. Reg. Toxicol. Pharmacol. 12: 179—211. 1990
[18| Travis C.B. Pharmacokinetics. In: Carcinogen Risk Analysis. Traves C.B. <cd) Contemporary issues, in risk
analysis, vol. 3, Plenum Press. New York. 1988
119| Wagner J.G. Pharmacokinetics for pharmaceutical scientists. Tcchnomic publishing Co. Inc., Lancaster, 1994
|20] Wartak J. Clinical Pharmacokinetics. A modern approach to individualised drug therapy. Clinical Pharma
cology and Therapeutics Series. Vol. 2. Praeger Publishers CBS Educational and Professional Publishing. 1983
(211 WcissingcrJ. Nonclinical pharmacologic*and toxicologicconsiderations forevaluating biologic products. Reg.
Toxicol. Pharmacol. 10: 255—263. 1989
|22] Welling P.G. Pharmacokinetic processes and mathematics. ACS Monograph 18S. American Chemical
Society, Washington DC, 1986
|23| Welling P.G., Dc 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
|25) ГОСТ P 51148—98 Изделия медицинские. Требования к образцам идокументации, представляемым
на токсикологические, санитарно-химические испытания, испытания на стерильность и иирогснностъ
7