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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Statistical Thinking for Non-Statisticians in Drug Regulation, 2e (Hardcover, 2nd Edition)
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Statistical Thinking for Non-Statisticians in Drug Regulation, 2e (Hardcover, 2nd Edition)
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Statistical Thinking for Non-Statisticians in Drug Regulation,
Second Edition, is a need-to-know guide to understanding
statistical methodology, statistical data and results within drug
development and clinical trials. It provides non-statisticians
working in the pharmaceutical and medical device industries with an
accessible introduction to the knowledge they need when working
with statistical information and communicating with statisticians.
It covers the statistical aspects of design, conduct, analysis and
presentation of data from clinical trials in drug regulation and
improves the ability to read, understand and critically appraise
statistical methodology in papers and reports. As such, it is
directly concerned with the day-to-day practice and the regulatory
requirements of drug development and clinical trials. Fully
conversant with current regulatory requirements, this second
edition includes five new chapters covering Bayesian statistics,
adaptive designs, observational studies, methods for safety
analysis and monitoring and statistics for diagnosis. Authored by a
respected lecturer and consultant to the pharmaceutical industry,
Statistical Thinking for Non-Statisticians in Drug Regulation is an
ideal guide for physicians, clinical research scientists, managers
and associates, data managers, medical writers, regulatory
personnel and for all non-statisticians working and learning within
the pharmaceutical industry.
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