The pharmaceutical industry has a complex relationship with the study and application of statistics: on the one hand, success in the marketplace and in the development and approval processes depends largely on statistical analysis, and software is making it easier to use statistics in these phases, regulatory requirements have demanded deeper and more complex analyses that even the most up-to-date computing may have trouble attaining exactly to specification. This edition, which has been updated to reflect recent trends and developments, includes chapters written by specialists and covers what regulatory bodies find to be acceptable methodologies. The 24 chapters include such topics as the FDA and the IND/NDA statistical review process, statistics within cancer clinical trials, clinical trials of analgesic drugs, interim analysis and bias, data monitoring, postmarketing studies and the impact of the global economy on tracking and reporting. Annotation © 2006 Book News, Inc., Portland, OR

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