Theory of Drug Development By: Eric B. Holmgren Publisher: Chapman and Hall/CRC Print ISBN: 9781138374683, 1138374687 eText ISBN: 9781466507470, 1466507470 Edition: 1st Copyright year: 2013 Format: PDF Available from $ 23.18 USD SKU 9781466507470R90 Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. It examines the drug development process from the perspectives of drug companies and regulatory agencies. By quantifying various ideas underlying drug development, the book shows how to systematically address problems, such as: Sizing a phase 2 trial and choosing the range of p-values that will trigger a follow-up phase 3 trial Deciding whether a drug should receive marketing approval based on its phase 2/3 development program and recent experience with other drugs in the s Download ebook: https://ouo.io/NYub3Lp
