Interface between regulation and statistics in drug development /
With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development...
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| Main Authors: | , , |
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton :
Chapman & Hall/CRC,
2021.
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| Edition: | 1st. |
| Series: | Chapman & Hall/CRC biostatistics series
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| Subjects: | |
| Online Access: | Taylor & Francis OCLC metadata license agreement |
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Add Tag | Summary: | With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities 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. |
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| Physical Description: | 1 online resource : illustrations (black and white). |
| ISBN: | 9781000215908 1000215903 9781000215700 1000215709 9781000215809 1000215806 9781003044208 1003044204 |
Interface between regulation and statistics in drug development /