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Full-Text Articles in Pharmacy and Pharmaceutical Sciences
Review Of Edison Bicudo, Pharmaceutical Research, Democracy And Conspiracy: International Clinical Trials In Local Medical Institutions, Roberto Abadie
Review Of Edison Bicudo, Pharmaceutical Research, Democracy And Conspiracy: International Clinical Trials In Local Medical Institutions, Roberto Abadie
Department of Sociology: Faculty Publications
The pharmaceutical industry is—along with the financial and weapons industries—one of the most globalized and profitable business domains. But they wouldn’t make any profits if they weren’t able to recruit research subjects to test an increasing number of drugs. This global trial economy creates its own assemblages of clinical trials, often run by hired contract research organizations (CROs), who fight among each other in a rat-race competition, promising quick and effective trials; at the same time, enterprising countries, hospitals, and doctors jump on the drug trial economy bandwagon by promising quick, endless access to a large pool of research subjects, …
Scientific And Regulatory Policy Committee (Srpc) Review*: Interpretation And Use Of Cell Proliferation Data In Cancer Risk Assessment, Charles E. Wood, Renee R. Hukkanen, Radhakrisha Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen
Scientific And Regulatory Policy Committee (Srpc) Review*: Interpretation And Use Of Cell Proliferation Data In Cancer Risk Assessment, Charles E. Wood, Renee R. Hukkanen, Radhakrisha Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen
Food and Drug Administration Papers
Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardiza- tion of proliferation assays will …