Statistical Thinking for Non-Statisticians in Drug Regulation

Richard Kay

maj 2013 · John Wiley & Sons

Om denne e-bog

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:

• Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
• Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
• Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

Om forfatteren

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.