STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and

Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reli

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory scie

This book was written for those who need to know how to collect, analyze and present data. It is meant to be a first course for practitioners, a book for privat

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes