Statistical Thinking for Non-Statisticians in Drug Regulation
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Beschreibung
Written by a well-known lecturer and consultant to thepharmaceutical industry, this book focuses on the pharmaceuticalnon-statistician working within a very strict regulatoryenvironment. Statistical Thinking for Clinical Trials inDrug Regulation presents the concepts and statisticalthinking behind medical studies with a direct connection to theregulatory environment so that readers can be clear where thestatistical methodology fits in with industry requirements.Pharmaceutical-related examples are used throughout to set theinformation in context. As a result, this book provides adetailed overview of the statistical aspects of the design,conduct, analysis and presentation of data from clinical trialswithin drug regulation.
Statistical Thinking for Clinical Trials in DrugRegulation:
* Assists pharmaceutical personnel in communicating effectivelywith statisticians using statistical language
* Improves the ability to read and understand statisticalmethodology in papers and reports and to critically appraisethat methodology
* Helps to understand the statistical aspects of the regulatoryframework better quoting extensively from regulatory guidelinesissued by the EMEA (European Medicines Evaluation Agency), ICH(International Committee on Harmonization and the FDA (Food andDrug Administration)
Autor*in
Richard Kay
Themen in »Statistical Thinking for Non-Statisticians in Drug Regulation«
Biostatistics Biostatistik Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie Pharmakologie u. Pharmazeutische Medizin Statistics Statistik
Stimmen zu »Statistical Thinking for Non-Statisticians in Drug Regulation«
"This book is a useful addition to the non-statisticians armouryand should be noted." (Journal of Mental Health, February2009)
"The information throughout this book is immediately useful... this book should be very useful for anyone involved in thedesign, analysis, and judgment of clinical trial data." (DrugInformation Journal, 2008)
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