Interface between Regulation and Statistics in Drug Development (Chapman & Hall/CRC Biostatistics Series) (Original PDF)
- Regulatory and statistical interactions throughout the drug development continuum
- The critical role of the statistician in relation to the changing regulatory and healthcare landscapes
- Statistical issues that commonly arise in the course of drug development and regulatory interactions
- Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities
The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.