If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.The primary objectives are to (1) determine the metabolism and pharmacological activities of the drug, the side effects associated with ... We will limit our discussion on the sample size calculations for answering the first three questions.
|Title||:||Dose Finding in Drug Development|
|Publisher||:||Springer Science & Business Media - 2006-12-29|