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Product DescriptionA comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of [...] Business Wire : ZymoGenetics Announces Results of Phase 2 Clinical Trials with Recombinant Human Thrombin; Company Reaffirms Plans to Move Forward with Phase 3 Clinical Program. Clinical Evaluations For Juveniles’ Competence To Stand Trial: A Guide For Legal Professionals Product DescriptionThe United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure [...] Product DescriptionThis digital document is an article from Family Practice News, published by International Medical News Group on December 1, 2004. The length of the article is 504 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital [...] Product DescriptionApply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to [...] Product DescriptionThis book dissects medical research methodology and through a penetrating inquiry into its triumphs and tragedies explains why correct answers are so hard to achieve. What emerges from this inquiry is the unexpected and stunning conclusion that medical researchers can never be sure that they’ve ended up with a truthful answer. In It’s Great! [...] |
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Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary
Product DescriptionAll investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The [...]