Statistical Methods in Healthcare

Front Cover
Frederick W. Faltin, Ron S. Kenett, Fabrizio Ruggeri
John Wiley & Sons, Jul 24, 2012 - Medical - 520 pages

In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed.

With a focus on finding solutions to these challenges, this book:

  • Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development.
  • Offers a broad coverage of standards and established methods through leading edge techniques.
  • Uses an integrated, case-study based approach, with focus on applications.
  • Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance.
  • Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes.
  • Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision.

Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.


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Statistical aspects in ICH FDA
Statistical methods in clinical trials
Pharmacometrics in drug
Interactive clinical trial design
Stagewise clinical trial experiments
Risk management in drug
The issue of bias in combined
Statistical issues in vaccine safety
Statistical methods for healthcare
Costing and performance
testing robustness

Process indicators and outcome
Statistical Process
Six Sigma in healthcare
Statistical process control in clinical
observational data
Quality of electronic medical records

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About the author (2012)

Frederick Faltin, Founder and Managing Director of The Faltin Group, USA.

Ron Kenett, Chairman and CEO of the KPA Group, Israel.

Fabrizio Ruggeri, CNR IMATI, Italy.

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