Volunteer human

Subject/trial subject An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control. (ICH) See also healthy volunteers, human subject. (ICH 1.57)... 

Bell, E., Willson, M., Wilman, A., Dave, S., 8c Silverstone, P. (2005). Differential effects of chronic lithium and valproate on brain activation in healthy volunteers. Human Psychopharmacology Clinical and Experimental, 20, 415—424. 

Determination of exposure and toxic effects of chemicals also requires knowledge of toxicokinetics. Toxicokinetics is the study of changes in the levels of toxic chemicals and their metabolites over time in various fluids, tissues, and excreta of the body, and determines mathematical relationships to explain these processes. These processes depend upon uptake rates and doses, metabolism, excretion, internal transport, and tissue distribution. Methods for determining these processes include studies with laboratory animals, volunteer human subjects, persons accidentally exposed to high doses of chemicals, and experiments with tissue or organs cultured in the laboratory. Computer simulations of such processes are often formulated using complex mathematical equations. 

Fexofenadine hydrochloride is 60-70% bound to plasma proteins, primarily albumin and ai-acid glycoprotein. The mean elimination half-life of fexofenadine was 14.4 h following administration of 60 mg, twice daily, in normal volunteers. Human mass balance studies documented a recovery of 80% and 11% of the fexofenadine hydro-... 

Van Gelderen CEM, Savelkoul TJF, Blom JL, Van Dokkum W and Kroes R (1993) The no-effect level of sodium bromide in healthy volunteers. Human Exp Toxicol 12 9-14. 

In a study conducted at our laboratory facility, volunteer human subjects hands were inoculated with a strain of E. coli. The subjects then donned vinyl food-server gloves having four small needle punctures in each. Within 5 minutes, sampling of the outside of the gloved hands showed that E. coli had been transferred from the hands onto the outer surfaces of the gloves. 

Hallam, KT., J.S. Olver, C. McGrath, and T.R. Norman. 2003. Comparative cognitive and psychomotor effects of single doses of Valeriana officianalis and triazolam in healthy volunteers. Human Psychapharmacol. 18(8) 619-625. 

Advantages of the K D module are that it provides a repellency system that allows for the measurement of mosquito contact and repellency as the number of mosquitoes probing and feeding, respectively. Unlike the ASTM model, the K D module limits this interaction between different chemical treatments this is achieved by having individual cells separated in the K D module. The K D module also increases the number of possible treatments and replicates. Finally, K D is amendable to multiple sources of attractants (human volunteers, human red blood cells, and artificial blood alternatives). One disadvantage of the K D module is that it does not allow for the quantification of spatial repellency. 

Phase I. This involves general testing for human pharmacology in healthy volunteers, ie, safe-dose adjustment deterrnination of absorption, metabohsm, and excretion patterns and monitoring for side effects. Usually fewer than 10 test subjects ate involved. 

Eventually, the proposed method was successfully applied to quantify clarithromycin in spiked human plasma and real samples from healthy volunteers after oral administration of the dmg indicating the utility of this method for clinical and bioavailability studies. 

Subacute and chronic toxicity of alcohol and alcohol ether sulfates has been extensively tested in several animals and sometimes humans. The duration of the tests was in some cases as long as 2 years. When administered below the toxic amount no specific damages were observed in any of the species tested [333]. No severe side effects were observed in the study by Swisher, carried out with volunteers who ingested considerable amounts of anionic and nonionic surfactants over long periods [348]. Similarly, the effects produced by the intake of daily doses of 1 g of alcohol sulfate per person over 8 weeks [349],... 

The primary objective of a Phase I trial is to assess the safety of the drug in humans. Studies are normally conducted in healthy male volunteers, although specific categories of subject may be used in certain cases. For example, to avoid the risk of low blood pressure, subjects with mild hypertension would be more appropriate for the evaluation of antihypertensive drugs, while patients are likely to be used in the case of drugs that are expected to produce significant toxic effects (e.g. anti-cancer cytotoxic drugs). Remuneration may be offered for participation in the study. The number of subjects is normally between 10 and 100 people. 

Evidence for this human health linkage has been suggested from (a) epidemiologic studies of exposed human populations, (b) human volunteer studies, and (c) animal experiments 14). Air pollution levels measured in southwestern Ontario, for instance, have been compared with hospital... 

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