By James R. Swearengen
The significance connected to swiftly constructing our biodefensive services has lately ended in a considerably elevated investment for biodefense study. consequently, researchers will reply with an attempt equivalent to the problem, generating a powerful physique of findings.
To make sure that this attempt keeps within the best demeanour, Biodefense: study method and Animal types offers a radical ancient and present overview of biodefense study, encouraging researchers to leverage suitable effects, instead of replica them. via construction at the paintings of others, scientists should be capable of continue in a fashion that makes the simplest use of accessible assets, whereas fending off pointless duplication of animal study.
Including contributions from well-known leaders within the box who've built and subtle the animal versions offered, this e-book examines these bacterial, viral, and poisonous brokers thought of to pose the best threats to public protection. every one part on a selected agent presents pertinent historical past info, by way of an outline of these animal versions hired in study and checking out and a dialogue of the way the findings translate to human influence.
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Extra resources for Biodefense: Research Methodology and Animal Models
It was expected that exploratory research with IND products to discover new treatment uses and to generate data requirements to apply for new drug marketing approval would continue to rigorously follow DoD and FDA requirements. But what if investigational status prevented lifesaving use of the only available product to protect against anticipated mass casualties produced by biological weapons? If drugs or vaccines still under IND status were needed for protecting or treating persons during a national emergency, they would have to be given according to research protocols.
Fm copy Page 33 Saturday, October 1, 2005 3:47 PM Scientific and Ethical Importance of Animal Models in Biodefense Research 33 Department for all research using volunteers . It distinguished between research conducted in Army Medical Services and that conducted by Army Medical Research and Development Command, and it identified the requirements for use of active duty military personnel as volunteers. Although it does not appear that these changes in the regulation were associated with either of the previous regulatory developments, it did necessitate negotiating a new MOU with the FDA because of the transfer of authority .
Also in 1972, the authority for regulating biologics including serums, vaccines, and blood products was transferred from the Public Health Service/National Institutes of Health to the FDA . S. Public Health Service syphilis study also created a major public controversy in 1972. This was a study of indigent black men from Tuskegee, Alabama, who were prevented from receiving treatment so that the natural course of syphilis could be studied. The program ran from 1932 until it was exposed in 1972.
Biodefense: Research Methodology and Animal Models by James R. Swearengen
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