Humanities, study of the

Findings from human studies of the impact of prenatal exposure to cannabis have been inconsistent. Cannabis users tend to have lower-birth weight infants, but the relationship between prenatal cannabis use and prematurity has not been consistent (Lee, 1998). 

No human studies of the pharmacokinetics of any ginger components have been conducted. Only one study in rats has been conducted to examine the pharmacokinetics of a ginger component, 6-gingerol. This study observed that after IV administration, the plasma concentration-time curve was best described by a two-compartment model with a rapid terminal elimination half-life of 7.2 minutes and a total body clearance of 16.8 mL/minute / kg. The protein binding of 6-gingerol was approx 92%. 

No review of subacute, subchronic, or chronic toxicity of chemical warfare nerve agents would be complete without discussion of the significant paper by Munro et al. that reviewed both animal and human studies of the nerve agents tabun (GA), sarin (GB), and VX. These studies included subacute, subchronic, and chronic toxicity studies in animals. Special attention was paid to the phenomenon of Organophosphorus-Induced Delayed Neuropathy (OPIDN). Reproductive toxicity and carcinogenicity tests were reviewed as well as in vitro studies of mutagenicity. Munro et al. s findings can be summarized as follows ... 

Homo erectus Many remains of this type have been found around the world. Pithecanthropus (Java man) and Sinanthropus (Peking man) both fall into this category. Homo erectus specimens are smaller than the average human today, with an appropriately smaller head and cranial cavity where the brain fits. However, the brain size is within the range of modern humans. Studies of the middie ear have shown that Homo erectus was just iike us. Remains have been found in the same strata and in close proximity to ordinary Homo sapiens (modern man), suggesting that they lived together. Studies have shown that brain size fluctuations within Homo sapiens seem to have no correlation to intellectuality, so Homo erectus would not have been the dumb, brute caveman that has been implied in the past. 

TABLE 5-1 Key Human Studies of the Carcinogenic Effects of Lead... 

Human Studies of the Consequences of AVF Creation Shortly after access creation, CO increases due to both left ventricular ejection fraction and heart rate increase [9]. These changes are probably driven by the decrease in systemic vascular resistance (caused by the arterial anastomosis of the VA) and by the increase of preload (venous return to the heart). Such changes could be considered rather physiological. However, within some weeks after access creation, Iwashima et al. [10] observed also an increase in the left ventricular diastolic diameter the indices of diastolic left ventricle function worsened, and levels of natriuretic peptides increased. The rise of B-natriuretic peptide (BNP) correlated with the diastolic function (E/A ratio, which is early/atrial left ventricular filling). Similar findings were observed in our center in a group that had their first VA with the access flow volume of only 789 361 ml/min 6 weeks after... 

I. Meredith, J. Ormiston, R. Whitbourn, et al. First-in-human study of the endeavor zotaro-limus-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions Endeavor I trial. Euro Intervention. 1 157-164, 2005. 

R. A. Murgatroyd, G.M. Worrall, und S. Crutzen Lessons leamt from the RISC 111 study of the influence of human factors on inspection reliability. 6 European Conference on Nondestructive Te.sting, Nice. 1994, Vol. 2, p 989-993... 

Also of value is the study of the history of technology (24,25) that affords insights into the history of the development of civilization. The eadiest existing written records, treatises of crafts people and artists on the techniques and materials with which they worked, date back to medieval times (26—29). For prehistoric human activities, the record is in the objects which remain, and only through the study of these can knowledge in this regard be furthered. 

Leather technologists have adopted the same histological techniques for the study of hide and skin stmcture as that used by the medical profession for the study of the stmcture and functions of human skin (1,2). 

A comprehensive study of the tolerance of laboratory animals to vapors of 2-nitropropane was reported in 1952 (100). In a study pubHshed in 1979, rabbits and rats survived exposure to nitromethane for six months at 750 and 100 ppm, respectively, with no unexpected findings (101). Similarly, no compound-related effects were found for rabbits exposed to 2-nitropropane at 200 ppm or for rabbits or rats exposed at 27 ppm. Liver damage was extensive in male rats exposed at 207 ppm for six months, and hepatocellular carcinomas were observed. Subsequendy, the International Agency for Research on Cancer (lARC) found that there is "sufficient evidence" to conclude that 2-nitropropane causes cancer in rats but that epidemiologic data are inadequate to reinforce the conclusion in humans (102). The National Toxicology Program also concluded that it "may reasonably be anticipated to be a carcinogen" (103). 

Health Factors. Dextrose products are substances that are presumed to be GRAS by the FDA (21). A study of the health aspects of dextrose, fmctose, and com symps has indicated that these sweeteners are not hazardous at levels of normal human consumption with the exception of a small contribution to the formation of dental caries (22). 

Although the precise mechanism of plasminogen activation is unknown, three principal theories have developed based on studies of the in vitro activation of native human plasminogen. Activation of native Glu-plasminogen in the absence of any plasmin inhibitor yields Lys —plasmin plus the so-called pre-activation peptides (PAP) formed by cleavage at LySg2 S E3 Activation takes place by a two-step mechanism in... 

S. Ramcharan, R. A. PeUegtin, R. M. Ray, and co-workers. The Walnut Creek Contraceptive Drug Study A Prospective Study of the Side Effects of Oral Contracptives, Vol. 3, U.S. Dept, of Health and Human Services, Government Printing Office, 1981. 

Cocks, A, T, and McElroy, W. J. (1984). Modeling studies of the concurrent growth and neutralization of sulfuric acid aerosols under conditions in the human airways. Eimironmefital Res. 35, 79-96. 

Murgatroyd, R. A., Tait, J. F. (1987)."A Case Study of the Application of the SHERPA Technique to the Dinorwig Spiral Casing Ultrasonic Testing System." Human Reliability Associates, 1 School House Higher Lane, Dalton, Wigan, Lancs., UK. 

Epidemiology is a discipline within the health sciences that deals with the study of the occurrence of disease in human populations. Epidemiologists arc generally concerned with groups of people who share certain characteristics. 

The applicant should provide justification for using the racemate. Where the interconversion of the enantiomers in vivo is more rapid than the distribution and elimination rates, then use of the racemate is justified. In cases where there is no such interconversion or it is slow, then differential pharmacological effects and fate of the enantiomers may be apparent. Use of the racemate may also be justified if any toxicity is associated with the pharmacological action and the therapeutic index is the same for both isomers. For preclinical assessment, pharmacodynamic, pharmacokinetic (using enantiospecific analytical methods) and appropriate toxicological studies of the individual enantiomers and the racemate will be needed. Clinical studies on human pharmacodynamics and tolerance, human pharmacokinetics and pharma-cotherapeutics will be required for the racemate and for the enantiomers as appropriate. 

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