Development research regulation

Research Challenges Critical to Policy Development and Regulation.522... 

Regulatory and ethical issues are often inextricably linked with novel therapies. Since cell-based therapy is a rapidly evolving field for both researchers and regulators, it is essential that each potential new cellular therapy be considered individually and that researchers maintain frequent and personal contact with regulatory agencies. Developers and regulators need to identify the issues that must be considered in order to best evaluate the risks and the benefits. 

The in-depth way the book covers the state of the art for mixture toxicology and ecotoxicology principles means it serves well as a textbook on the subject. At the same time, the inclusion of the considerations on application of novel developments in these principles, and their integration across human and environmental mixture risk assessment, makes it an ideal tool for researchers, regulators, and other risk assessment practitioners as mixture considerations start to enter regulatory forums over the next years. 

In the United States, GLP regulations (21 CFR 58) apply to safety or animal toxicology studies performed during research and development. These regulations define GLPs for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products... 

Phani K. Raj, et al. 2010. Pritchard. Hazardous materials transportation on U.S. railroads application of risk analysis methods to decision making in development of regulations. Journal of the Transportation Research Board. 17(7) 22-26. 

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