Statistical Thinking for Non-Statisticians in Drug Regulation
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Beschreibung
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: * aid communication between statisticians and non-statisticians * help in the critical review of reports and publications and * enable the more effective use of statistical arguments within the regulatory process. 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.
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