Few books deal with issues faced by researchers in the areas of pre-clinical animal studies, analytical method and process development, manufacturing control, the implementation of Bayesian applications for pharmaceutical problems, using modern computational tools such as R. This book does.
Few books deal with issues faced by researchers in the areas of pre-clinical animal studies, analytical method and process development, manufacturing control, the implementation of Bayesian applications for pharmaceutical problems, using modern computational tools such as R. This book does.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Harry Yang is Senior Director and Head of Statistical Sciences at MedImmune. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published six statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. Dr. Yang is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick is Director of Statistical Sciences at MedImmune. He has extensively contributed statistical methods to the biopharmaceutical literature. Dr. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. He served on IPAC-RS and has chaired several national statistical conferences.
Inhaltsangabe
Background. Drug Research and Development. Basics of Bayesian analysis. Bayesian Estimation of Sample Size and Power. Pre-Clinical and Clinical Research. Pre-clinical efficacy study. Futility analysis. Phase 3 Clinical Trial. Chemistry, Manufacturing, and Control. Analytical method. Process Development. Bayesian Approach to Statistical Process Control.
Background. Drug Research and Development. Basics of Bayesian analysis. Bayesian Estimation of Sample Size and Power. Pre-Clinical and Clinical Research. Pre-clinical efficacy study. Futility analysis. Phase 3 Clinical Trial. Chemistry, Manufacturing, and Control. Analytical method. Process Development. Bayesian Approach to Statistical Process Control.
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