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Showing posts from November 1, 2009

Nanotechnology Interest Group

BayBiotech.NET As per definition of National Technology Initiative, nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers. Encompassing nanoscale science, engineering, and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. According to NTIG at this scale unusual physical, chemical, and biological properties can emerge in materials and the properties may differ in important ways from the properties of bulk materials and single atoms or molecules. Recognizing a great potential for this technology for drug delivery/ device in medicine, in July 2007 FDA issued a press release outlining the regulatory challenges that the implementation of the technology will have for the agency and geared up towards developing guidance as well as regulations to address the benefits and risks of drugs and devices using nanotechnology. As it is obvious, development and Implementation of

International Compilation of Human Research Protections 2009 Edition

BayBiotech.NET Office for Human Research Protections (U.S. Department of Health and Human Services) has compiled a list of 1,100 laws, regulations, and guidelines governing human subject’s research in 92 countries, as well as standards from a number of international and regional organizations. This 85 pages list has been developed for IRBs/Ethics Committees, researchers, sponsors, and others who are involved in international research with a purpose to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure those standards are followed appropriately. The 2009 Edition is the latest updated version that includes numerous additions and updates to the 2008 Edition, and further includes the laws, regulations, and/or guidelines for 7 new countries: Burma (also known as Myanmar), Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam. If you are clinical research personnel and would like to get the l