Biological agents humanization

Two topical skin protectants in development by DoD have been shown to protect rabbits from the dermal effects of T-2 toxin for at least 2 hours, but neither is available for human use. An IND has been submitted to the FDA for the simpler of the two, which offers only passive protection from T-2 toxin and a number of other potential chemical and biological agents. Human safety has also been demonstrated for this product, a manufacturing contract awarded, and an NDA is being prepared in hopes... 

Effects of indoor air pollutants on humans are essentially the same as those described in Chapter 7. However, there can be some additional pollutant exposures in the indoor environment that are not common in the ambient setting. From the listing in Table 23-1, radon exposures indoors present a radiation hazard for the development of lung cancer. Environmental tobacco smoke has been found to cause lung cancer and other respiratory diseases. Biological agents such as molds and other toxins may be a more likely exposure hazard indoors than outside. 

Biological agent Any of a range of microorganisms which have an adverse effect on human health, including those genetically modified cell cultures and en-doparasites. 

Reference period A specified time period allowed for human exposure to a specific concentration of a biological agent or chemical. 

Table 13.1 Polyclonal antibody preparations of human or animal origin used to induce passive immunity against specific biological agents...

Stressor is a chemical, physical or biological agent that can cause adverse effects in non-human ecological components ranging from organisms, populations, and communities, to ecosystems (Smrchek and Zeeman,... 

Defining how humans are exposed to radioactive materials and chemi-cal/biological agents... 

Identifying how exposure to radioactive materials and chemical and biological agents can impact human health, human genetics, or an unborn fetus... 

Biosafety Level 1—Suitable for work involving well-characterized biological agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to lab personnel and the environment. Work is generally conducted on open benchtops using standard microbiological practices. 

The EHC monographs provide critical reviews on the effect on human health and the environment of chemicals and of combinations of chemicals and physical and biological agents. As such, they include and review studies that are of direct relevance for the evaluation. However, they do not describe every study carried out. Worldwide data are used and are quoted from original studies, not from abstracts or reviews. Both published and unpublished reports are considered and it is incumbent on the authors to assess all the original articles cited in the references. Preference is... 

Normal immunoglobulin Human Specificities against variety of infectious and other biological agents prevalent in general population... 

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