Interface between Regulation and Statistics in Drug Development (Chapman & Hall/CRC Biostatistics Series)

"The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book"--

Science & Math

Alemayehu, Demissie

GAFFNEY, Michael

Emir, Birol

Biological Sciences

Chapman and Hall/CRC

Patient-Reported Outcomes (Chapman & Hall/CRC Biostatistics Series)

Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.

Patient-Reported Outcomes: Measurement, Implementation and Interpretation (Chapman & Hall/CRC Biostatistics Series)

Cappelleri, Joseph C.

Zou, Kelly H.

Bushmakin, Andrew G.

Alvir, Jose Ma. J.

Symonds, Tara

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