{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T20:20:12Z","timestamp":1777666812442,"version":"3.51.4"},"reference-count":28,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[1994,6,1]],"date-time":"1994-06-01T00:00:00Z","timestamp":770428800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hum Exp Toxicol"],"published-print":{"date-parts":[[1994,6]]},"abstract":"<jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1177\/096032719401300604","type":"journal-article","created":{"date-parts":[[2008,12,24]],"date-time":"2008-12-24T01:08:04Z","timestamp":1230080884000},"page":"383-392","source":"Crossref","is-referenced-by-count":12,"title":["Human Volunteer Studies with Non-Pharmaceutical Chemicals: Metabolism and Pharmacokinetic Studies"],"prefix":"10.1177","volume":"13","author":[{"given":"M.F.","family":"Wilks","sequence":"first","affiliation":[{"name":"Stewardship and Safety Department, ZENECA Agrochemicals, Fernhurst, Haslemere, Surrey GU27 3JE"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.H.","family":"Woollen","sequence":"additional","affiliation":[{"name":"Human Toxicology Team, ZENECA Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, SK10 4TJ, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[1994,6,1]]},"reference":[{"key":"atypb1","unstructured":"Hayes WJ Studies in humans. In: Handbook of Pesticide Toxicology. Hayes WJ & Laws ER eds, pp. 215-244, New York: Academic Press, 1991."},{"key":"atypb2","volume-title":"American Conference of Governmental Industrial Hygienists"},{"key":"atypb3","volume-title":"Maximum Concentrations at the Workplace and Biological Tolerance Values for Working Materials","author":"Deutsche Forschungsgemeinschaft .","year":"1991"},{"key":"atypb4","first-page":"F14","volume":"4","author":"Fiserova-Bergerova V.","year":"1989","journal-title":"Applied Industrial Hygiene"},{"key":"atypb5","volume-title":"IUPAC. Pesticide Metabolism: Extrapolation from Animals to Man","author":"Miyamoto J.","year":"1988"},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-08-029224-3.50065-4"},{"key":"atypb7","first-page":"264","volume":"19","author":"World Medical Association.","year":"1992","journal-title":"Medicine and Health Care"},{"key":"atypb8","volume-title":"Research on Healthy Volunteers. A Working Party Report","author":"Royal College of Physicians.","year":"1986"},{"key":"atypb9","volume-title":"Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (Second Edition)","author":"Royal College of Physicians.","year":"1990"},{"key":"atypb10","volume-title":"Good Laboratory Practice: The United Kingdom Compliance Programme","author":"UK Department of Health","year":"1989"},{"key":"atypb11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0773.1990.tb00847.x"},{"key":"atypb12","unstructured":"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."},{"key":"atypb13","doi-asserted-by":"publisher","DOI":"10.1177\/096032718900800602"},{"key":"atypb14","unstructured":"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."},{"key":"atypb15","doi-asserted-by":"publisher","DOI":"10.1016\/0041-008X(84)90046-2"},{"key":"atypb16","doi-asserted-by":"publisher","DOI":"10.1016\/0041-008X(84)90007-3"},{"key":"atypb17","doi-asserted-by":"publisher","DOI":"10.3109\/00498259209049904"},{"key":"atypb18","doi-asserted-by":"publisher","DOI":"10.1007\/BF00379550"},{"key":"atypb19","volume-title":"Plasticisers: Continuing Surveillance. 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