Статус документа
Статус документа

ГОСТ ISO 10993-16-2011 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 16. Моделирование и исследование токсикокинетики продуктов деградации и вымывания

Библиография

[1]

ISO 10993-2:1992

Biological evaluation of medical devices - Part 2: Animal welfare requirements

Оценка биологическая медицинских устройств. Часть 2. Требования к благополучию животных

[2]

ISO 10993-12:1996

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

Оценка биологическая медицинских устройств. Часть 12. Подготовка проб и эталонных материалов

[3]

Andersen М.Е., Clewell H.J. Ill, Gargas M.L., Smith F.A. and Reitz R.H. Physiologically-based pharmacokinetics and the risk assessment process for methylene chloride. Toxicol. Appl. Pharmacol. 54: 100-116; 1987

[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 bioavailability section of an application. Department of Health and Human Services

[6]

Hattis D., White P., Mamorstein 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]

Internatinal Programme on Chemical Safety (IPCS). Principles of toxicokinetic 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 D.J., Roberts S., Price V., Longacre S. and Smith С. Pharmacokinetic considerations in toxicity testing. Drug Metab. Rev. 13: 983-1007, 1982

[10]

Katzper M. The uze of visual programming for pharmacokinetic and harmacodynamic simulation. Centre for Drug Evaluation and Research, FDA, 5600 Fishers Lane, Rockville MD 20857

[11]

Lin C.S., Shoaf S.E. and Griffiths J.С. 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 (2 edition). Lea and Febiger, Philadelphia, 1989

[16]

Smith D.A., Humphrey M.J. and Charuel С. Design of toxicokinetic studies. Xenobiotica 20: 1187-1199, 1990

[17]

Speid 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 risk 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 Series, Vol. 2. Praeger Publishers CBS Educational and Professional Publishing, 1983

[21]

Weissinger J. Nonclinical 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