Clinical Drug Development Data Analysis: Concepts

Examines the process of planning, collecting, analyzing, and reporting data from drug development studies. Focuses on the goals of each phase (1–4) of the clinical drug development process and how to achieve these objectives within the confines of the FDA regulations and ICH guidelines. Covers requirements in other countries, including the UK Data Protection Act, issues related to the differences between the development of drugs for oncologic or AIDS indications compared to traditional drugs, cultural influences, current standards of therapy, the need for validated tools, and failure analyses.

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