Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.
Statistical Thinking for Clinical Trials in Drug Regulation:
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Within the complex processes of planning, and conducting, analysing and reporting clinical trials in the pharmaceutical industry, the interaction between the statistician and non-statistician is not always a successful one. There is often of confusion on the part of the non-specialist in understanding specific statistical terms and those that appear the same or similar which can make operating within a regulatory environment difficult.
This book presents the statistical methods employed by the pharmaceutical industry in relation to current regulatory requirements and explains them in ways that are easily understandable by providing an insight into their interpretation and context in which they are used. The book does not aim to turn non-statisticians into statisticians but aims to:
Those working within the pharmaceutical industry: physicians, investigators, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in quality assurance will find this book a valuable learning tool on statistics; a key aspect of being familiar with the rules and regulations that govern their use and interpretation.About the Author:
Richard Kay. PhD Medical Statistics. The author worked within academia until 1989 when he set up his own company offering statistics and data management services to the pharmaceutical industry. Since 2005, he works as an Independent Statistical Consultant providing full consultancy and training course service to the Pharmaceutical and Medical Device industries. The author currently lectures and runs courses for the pharmaceutical industry in all major European countries: UK, France, Ireland, Belgium, The Netherlands, Germany, Spain, Italy, Switzerland, Sweden, Denmark, Russia and South Africa and US. His lectures are predominantly given within Pharma Cos or CROs.
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Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. 1. Codice libro della libreria DADAX0470319712
Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. book. Codice libro della libreria 0470319712
Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. Codice libro della libreria P110470319712
Descrizione libro Wiley-Interscience 2007-10-15, 2007. Hardcover. Condizione libro: New. 1. 0470319712. Codice libro della libreria 695349