Updated and expanded to reflect the recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies.

Updated and expanded to reflect the most recent trends and challenges in pharmaceutical statistics, this third edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies. This approach provides insight into the approval process from those reviewing the statistical analyses as well as those who have had success in getting a new product approved. New and updated chapters reflect the increasingly global nature of the industry, the increasing trend toward non-inferiority testing, adaptive design in clinical trials, global harmonization of regulatory standards, bridging strategies in global drug development, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies.

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