| Автор | Wilks, M.F. |
| Автор | Woollen, B.H. |
| Дата выпуска | 1994 |
| dc.description | 1 Human volunteer studies are an essential part of drug development but their use in the area of non-pharmaceutical chemicals has so far been very limited. Such studies can have considerable value in the assessment and improvement of the safe use of chemicals.2 Once metabolic pathways and target metabolites have been identified in volunteers this information can be used in studies in the workplace or in the general population. Studies should be performed selectively only if there is both a toxic hazard and a significant exposure potential. In addition, they should only be carried out if the required information cannot be obtained in any other way.3 Volunteer studies with non-pharmaceuticals have become increasingly acceptable in the light of established international guidelines, no-fault compensation, improvements in study design and technical developments which allow the use of very low dose levels. The final decision on whether to carry out a study must always rest with an independent ethical committee.4 The practical aspects of the study should be specified in a detailed protocol conforming with the principles of good clinical practice. The safety of volunteers must be of paramount concern throughout. Depending on the nature of the chemical and the study, it may be advisable to carry out studies in a clinical facility where equipment is available for the treatment of any emergencies that might occur.5 Numerous investigators have now shown that human volunteer studies are ethically acceptable, practicable and yield important information. The risk to volunteers is minimal and this approach can lead to an improved foundation for occupational hygiene standards, more accurate risk assessment and thus better protection of the workforce and the general population. |
| Издатель | Sage Publications |
| Название | Human Volunteer Studies with Non-Pharmaceutical Chemicals: Metabolism and Pharmacokinetic Studies |
| Тип | Journal Article |
| DOI | 10.1177/096032719401300604 |
| Print ISSN | 0960-3271 |
| Журнал | Human and Experimental Toxicology |
| Том | 13 |
| Первая страница | 383 |
| Последняя страница | 392 |
| Аффилиация | Wilks, M.F., Stewardship and Safety Department, ZENECA Agrochemicals, Fernhurst, Haslemere, Surrey GU27 3JE |
| Аффилиация | Woollen, B.H., Human Toxicology Team, ZENECA Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, SK10 4TJ, UK |
| Выпуск | 6 |
| Библиографическая ссылка | Hayes WJStudies in humans. In: Handbook of Pesticide Toxicology. Hayes WJ & Laws ER eds, pp. 215-244, New York: Academic Press, 1991. |
| Библиографическая ссылка | American Conference of Governmental Industrial Hygienists1991-1992Threshold Limit Values for Chemical Substances and Physical Agents. Cincinnati, Ohio: ACGIH, 1991. |
| Библиографическая ссылка | Deutsche Forschungsgemeinschaft .Maximum Concentrations at the Workplace and Biological Tolerance Values for Working Materials. VCH , Weinheim1991. |
| Библиографическая ссылка | Fiserova-Bergerova V. & Pierce JT Biological Monitoring V: Dermal Absorption . Applied Industrial Hygiene 1989; 4: F14-F21. |
| Библиографическая ссылка | Miyamoto J., Kaneko H., Hutson DH, Esser HO, Gorbach S. & Dorn E. IUPAC. Pesticide Metabolism: Extrapolation from Animals to Man. London: Blackwell Scientific Publications, 1988. |
| Библиографическая ссылка | Hayes WJEthical considerations involving studies of pesticides and other xenobiotics in man. In: IUPAC Pesticide Chemistry: Human Welfare and Environment. Volume 3. Mode of Action, Metabolism and Toxicology, Miyamoto J & Kearney PC, eds, pp. 387-394. London: Pergamon, 1983. |
| Библиографическая ссылка | World Medical Association.Declaration of Helsinki. LawMedicine and Health Care1992; 19: 264-5. |
| Библиографическая ссылка | Royal College of Physicians.Research on Healthy Volunteers. A Working Party Report. London: Royal College of Physicians, 1986. |
| Библиографическая ссылка | Royal College of Physicians.Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (Second Edition). London: Royal College of Physicians, 1990. |
| Библиографическая ссылка | UK Department of Health ( 1989). Good Laboratory Practice: The United Kingdom Compliance Programme. |
| Библиографическая ссылка | CPMP Working Party on Efficacy of Medicinal Products.EEC Note for Guidance: Good Clinical Practice for trials on medicinal products in the European Community. Pharmacology and Toxicology1990; 67: 361-72. |
| Библиографическая ссылка | UK Department of Health (1984). Administration of Radioactive Substances Advisory Committee. Enclosure (HN (84) 5): Notes of Guidance on the Administration of Radioactive Substances for Purposes of Diagnosis, Treatment or Research. |
| Библиографическая ссылка | Carmichael NG, Nolan RJ, Perkins JM, Davies R. & Warrington SJ Oral and Dermal Pharmacokinetics of Triclopyr in Human Volunteers. Human Toxicology 1989; 8: 431-7. |
| Библиографическая ссылка | Meuling Wja, Bragt PC, Leenheers LH & Kort WLAM de Dose Excretion Studies with the Pesticide Propoxur in Volunteers. In: Prediction of Percutaneous Penetration, volume 2. Scott RC, Guy RH, Hadgraft J, Bodde HE eds. London: IBC Technical Services, pp. 13-19, 1992. |
| Библиографическая ссылка | Nolan RJ, Rick DL, Freshour NL & Saunders JH Clorpyrifos: Pharmacokinetics in Human Volunteers. Toxicology and Applied Pharmacology 1984; 73: 8-15. |
| Библиографическая ссылка | Nolan RJ, Freshour NL, Kastl PE & Saunders JH Pharmacokinetics of Picloram in Male Volunteers. Toxicology and Applied Pharmacology 1984; 76: 264-9. |
| Библиографическая ссылка | Woollen BH, Marsh JR, Laird Wjd & Leeser JE The Metabolism of Cypermethrin in Man: Difference in metabolite profiles following oral and dermal administration. Xenobiotica 1992; 22: 983-93. |
| Библиографическая ссылка | Woollen BH, Marsh JR, Mahler JD et al. Human inhalation pharmacokinetics of chlorodifluoromethane (HCFC22) . International Archives of Occupational and Environmental Health 1992; 64: 383-7. |
| Библиографическая ссылка | Ministry of Agriculture, Fisheries and Food.Plasticisers: Continuing Surveillance. Food Surveillance Paper No. 30. London: HMSO, 1990. |
| Библиографическая ссылка | Loftus NJ, Laird Wjd, Wilks MF, Steel GT & Woollen BH A further study into the disposition of deuterium labelled di-2-(ethylhexyl) adipate (DEHA) in human volunteers following oral administration. Human & Experimental Toxicology 1992; 11: 395-6. |
| Библиографическая ссылка | De Baun J., Bova DL, Tseng CK & Meunn JJ Metabolism of [ring 14C] Ordram (molinate) in the rat. 2. Urinary metabolism . Journal of Agricultural and Food Chemistry 1978; 26: 1098-104. |
| Библиографическая ссылка | Wilks MF, Woollen BH, Marsh JR, Batten PL & Chester G. Biological monitoring for pesticide exposure - the role of human volunteer studies. International Archives of Occupational and Environmental Health 1993; 65: S189-92. |
| Библиографическая ссылка | Woollen BH, Hart TB, Batten PL, et al. Pharmacokinetics of fluazifop-butyl in human volunteers: 1: Oral dosing. Human & Experimental Toxicology1991; 10: 39-43. |
| Библиографическая ссылка | Ramsey JD, Woollen BH, Auton TR, Batten PL & Leeser JE Pharmacokinetics of fluazifop-butyl in human volunteers. II: Dermal dosing . Human & Experimental Toxicology 1992 ; 11: 247-54. |
| Библиографическая ссылка | Chester G., Loftus NJ & Woollen BH Reductions of mixer-loader-applicator dermal exposure and absorption by use of protective gloves. Society of Environmental Toxicology and Chemistry Eleventh Annual Meeting. Arlington, Virginia. November 11-15, 1990. Abstract Number 199. |
| Библиографическая ссылка | Auton TR, Ramsey JD & Woollen BH Modelling dermal pharmacokinetics using in vitro data. Part I. Fluazifop-butyl in the rat. Human & Experimental Toxicology 1993; 12: 199-206. |
| Библиографическая ссылка | Auton TR, Ramsey JD & Woollen BH Modelling dermal pharmacokinetics using in vitro data. Part II. Fluazifop-butyl in man. Human & Experimental Toxicology 1993; 12: 207-13. |
| Библиографическая ссылка | Auton TR, Westhead DR, Woollen BH, Scott RC & Wilks MF A physiologically based model of dermal absorption. Human & Experimental Toxicology 1994; 13: 51-60. |
