Human volunteer research

This will extend, and partially replace, the traditional approach to biomedical research that is based on studying living cells or tissues in vitro, or on obtaining data from human volunteers in vivo, by introducing in silico experiments (a term, derived from the currently prevaihng sihcon-based computer chips). 

There have been several assessments of research concerning the health effects of MTBE and other oxygenated fuels.1617 Recently, results of a study of the movement of MTBE between tissues in human volunteers were published.18 U.S. EPA is currently updating its assessment of the health effects of MTBE. 

In the first phase of their research, Squibb tested a short-chain peptide isolated from the venom of the viper Bothrops jararaca, with which Vane was working in the laboratory, in human volunteers and showed that it did, indeed, inhibit the conversion of angiotensin I to angiotensin II after intravenous injection. The peptide was also shown to reduce blood pressure in patients when injected. Since the vast majority of peptides cannot be absorbed from the GI tract, Squibb scientists set out to prepare a nonpeptide compound that could be used orally and manufactured at acceptable cost. The design of a true peptidomimetic that became orally active had not been accomplished at that time. Squibb then carried out... 

Chemical warfare research and development had already been authorized and conducted during the 1950s, including experiments with human volunteers. These programs were heavily cloaked in secrecy, primarily because of fears that the public, or even Congress, might object and try to discontinue such research. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

While a lot of basic kinetic research has been done in normal human volunteers (because the conditions of the experiments can be standardized in them and it is also ethical to take, with consent, the multiple blood samples needed), the practical purpose of drug kinetics is to improve our ability to treat patients and we cannot assume that drug kinetics will remain the same when someone is ill. Many research reports and reviews have been written about changing kinetics in disease and what follows is only a brief summary. 

One famous set of DMT studies involves physician Rick Strassman, Clinical Associate Professor of Psychiatry at the University of New Mexico School of Medicine. In 1990, Strassman began the first new research in the United States in more than twenty years on the effects of psychedelic drugs on humans. During the project s five years, he administered approximately four hundred doses of DMT to sixty human volunteers. 

The issue of the use of human volunteers was considered by the Armed Forces Medical Policy Council during the early 1950 s. The Council concluded that essential data could not be obtained unless human volunteers were used, and the use of humans in medical research was authorized. By 1954, the Chemical Corps (formerly CWS) had established a framework within which to conduct human experimentation, but it lacked an adequate pool of volunteers. In 1955, it was decided that the most practical source of volunteers would be enlisted men stationed at Army installations in the vicinity of Edgewood Arsenal. 

When we encapsulate these enzymes in little beads of fat (then referred to as photosomes) they penetrate tissue. This formulation proved capable of repairing damaged skin when researchers tested it on human volunteers. 

The ethical implications also cannot be ignored. Any research that uses human volunteers must examine its motives and methods to make certain that human beings are not being manipulated like objects for purposes they do not understand or share. But in research with powerful mental chemicals that may influence the most cherished human functions and values, the ethical problem is even more acute. The mystical experience, historically, has filled man with wondrous awe... 

Walters, T. J., Baer D. G., Greydanus, D. J., and Wenke, J. C., Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers, USAISR Technical Report, U. S. Army Institute of Surgical Research, Fort Sam Houston, Texas, September 2005. 

The psychotropic effects of Salvia divinorum have generated interest among psychopharmacologists and other scientists. Chemical analysis of the plant has succeeded in identifying the active substance, which is now known as salvinorin A. Research on animals and human volunteers indicates that the psychoactive effects of salvinorin A are comparable to those of mescaline. As little as 200-500 meg of salvinorin A will reliably produce hallucinations in people, when the crystallized substance is vaporized over a flame and inhaled. On the basis of effective dose, salvinorin A is the most potent natural hallucinogen known. The leaves have been determined to contain 1—4 mg of salvinorin A per gram of dry weight. 

Method Genomics, traditional biomedical research Animal models, in vitro assays Rational drug design, high throughput screening, combinatorial chemistry Medicinal chemistry In vivo assays, animal models I N D Healthy human volunteers Patients N Patients D A... 

This web site, a service of the United States National Institutes of Health, provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial s purpose, who may participate, locations, and phone numbers for more details, http //www.clinicaltrials.gov. 

Preuss, H.C., Bagchi, D., Bagchi, M., Rao, C.V.S., Satyanarayana, S. and Dey, D.K. (2004) Efficacy of a novel, natural extract of (-)-hydroxycitric acid (HCA-SX) and a combination of HCA-SX, niacin-bound chromium and Cymnema syivestre extract in weight management in human volunteers a pilot study. Nutrition Research 24(1), 45-58. 

Breier, A. 1989, A.E. Bennett award paper. Experimental approaches to human stress research assessment of neurobiological mechanisms of stress in volunteers and psychiatric patients, Biol.Psychiatry, vol. 26, no. 5, pp. 438-462. 

Gobburu, J., Agerso, H., Jusko, W., and Ynddal, L., Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers, Pharmaceutical Research, Vol. 16, No. 9, 1999, pp. 1412-1416. 

Institute for Behavioral Research 1965 The Effects of Two Dose Levels of a CROL Compound Upon a Delayed Matching Performance with Human Volunteer Subjects. Contract No. DA-18-108-AMC-26(A)-CP3-40. 

N. Osakabe, S. Baba, A. Yasuda, et al. Daily cocoa intake reduces the susceptibility of low-density lipoprotein to oxidation as demonstrated in healthy human volunteers. Free Radical Research 34... 

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