Interface between regulation and statistics in drug development /

Interface between regulation and statistics in drug development /

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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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Bibliographic Details
Main Authors: Alemayehu, Demissie (Author), Emir, Birol (Author), Gaffney, Michael, active 1983 (Author)
Format: Electronic eBook
Language:English
Published: Boca Raton : Chapman & Hall/CRC, 2021.
Edition:1st.
Series:Chapman & Hall/CRC biostatistics series
Subjects:
United States. > Food and Drug Administration > Rules and practice.
Drugs > United States > Testing > Statistical methods.
Drugs > Testing > Law and legislation > United States.
Clinical trials > United States > Statistical methods.
Clinical trials > Law and legislation > United States.
Clinical trials > Reporting > United States.
Drug development > United States.
Pharmaceutical policy > United States.
MEDICAL / Biostatistics
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
Online Access:Taylor & Francis
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