Drug development is the process of finding and producing
therapeutically useful pharmaceuticals, turning them into safe and
effective medicine, and producing reliable information regarding
the appropriate dosage and dosing intervals. With regulatory
authorities demanding increasingly higher standards in such
developments, statistics has become an intrinsic and critical
element in the design and conduct of drug development programmes.
"Statistical Issues in Drug Development" presents an essential
and thought provoking guide to the statistical issues and
controversies involved in drug development.
This highly readable second edition has been updated to include:
Comprehensive coverage of the design and interpretation of clinical
trials. Expanded sections on missing data, equivalence,
meta-analysis and dose finding. An examination of both Bayesian and
frequentist methods. A new chapter on pharmacogenomics and expanded
coverage of pharmaco-epidemiology and pharmaco-economics. Coverage
of the ICH guidelines, in particular ICH E9, Statistical Principles
for Clinical Trials.
It is hoped that the book will stimulate dialogue between
statisticians and life scientists working within the pharmaceutical
industry. The accessible and wide-ranging coverage make it
essential reading for both statisticians and non-statisticians
working in the pharmaceutical industry, regulatory bodies and
medical research institutes. There is also much to benefit
undergraduate and postgraduate students whose courses include a
medical statistics component.
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