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Become an expert on how to directly apply pharmaceutical statistics to scientific research and clinical evaluation. Written in an easy-to-read format and utilizing practical examples and solutions, this timely resource is a perfect guide for pharmaceutical scientists who need to report on clinical trials data and bioequivalence studies. The Fifth Edition has been updated and expanded to include the most complete and comprehensive information on the various statistical applications and research issues in the pharmaceutical industry today. Why every pharmaceutical scientist should own a copy of the Fifth Edition:

1. stay current-with the most recent industry information on the modern principles and practices in statistics
2. logically determine sample size-in bioequivalence and clinical trials, even for those with complicated designs
3. gain FDA acceptance--of post-approval manufacturing changes quicker and easier by way of the in vitro in vivo correiation technique in the drug development process
4. receive step-by-step guidance with an accompanying CD-containing SAS and Excel-based programs that enable you to fully analyze key concepts and text examples
5. quickly and accurately evaluate-pharmaceutical data using various regression techniques

Additional Information

Publisher	CRC Press
Binding	Hardcover
Year	2022
Edition	5/e
Pages	674
Author	Sanford Bolton
About the Author	SANFORD BOLTON is Consultant, Tucson, Arizona, USA. Dr. Bolton received his Ph.D. from the University of Wisconsin- Madison School of Pharmacy, Madison, Wisconsin, USA. A fellow of the American Association of Pharmaceutical Scientists, Dr. Bolton serves on the editorial board of Journal of Clinical Research Practice and Drug Regulatory Affairs, is a reviewer for Journal of Pharmaceutical Sciences, and is a former member of the FDA panel on Individual Bioequivalence. He is the author or co-author of more than 100 publications, including the Fourth Edition of Informa Healthcare's Pharmaceutical Statistics. CHARLES BON is President, Biostudy Solutions, LLC, Wilmington, North Carolina, USA. Mr. Bon received his Masters Degree in Chemistry from the Indiana University of Pennsylvania, Indiana, Pennsylvania, USA. He is a member of the American Association of Pharmaceutical Scientists and formerly served as Member of the FDA Blue Ribbon Panel for Individual Bioequivalence, as well the FDA Expert Panel for Population and Individual Bioequivalence. Mr. Bon is also the co-author of the Fourth Edition of Informa Healthcare's Pharmaceutical Statistics.

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