Innovative Methods For Rare Disease Drug Development Chapman Hallcrc Biostatistics Series

Innovative Methods For Rare Disease Drug Development Chapman Hallcrc Biostatistics Series
Reviews critical issues (e.g., endpoint/margin selection, sample size requirement and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval. Makes recommendations to accurately and reliably evaluate rare diseases regulatory submissions. Proposes innovative study...