Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. This book introduces the drug development process, the design and analysis of clinical trials. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information. A drug label is a high level summary of results obtained from many scientific experiments. When you go to the pharmacy and fill a prescription, have you ever wondered if the dose of the medication is right for you? Can the dose be too low so that the drug will not work? Can the dose be too high that it may cause some potential problem? How do people learn about dosing information? This book answers some of these questions.ĭosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency.
