Titlebook: Cancer Clinical Trials: Proactive Strategies; Stanley P. L. Leong Book 2007 Springer-Verlag US 2007 breast cancer.cancer.cancer research.c

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The Role of the FDA in Cancer Clinical Trials,ical investigator..The FDA has unique resources in terms of expertise and institutional experience, and has well defined mechanisms for interaction. Product development is viewed as a shared responsibility and the FDA can be an important and supportive partner in the process.

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The Role of the FDA in Cancer Clinical Trials,uditing procedures, inspections, post marketing surveillance, safety analysis, preclinical data expectations, pharmacokinetics recommendations, Institutional Review Boards, Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Practice and policy development have not been broached in

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The Audit Process and How to Ensure a Successful Audit, malignancies. As an obligation to both the scientific community and the general public, the cooperative audit programs and the CTMB collaborate to ensure that the conduct of clinical trials are meticulous and the data are validated. However, audit programs should be viewed not merely as a surveilla

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