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Books > Science & Mathematics > Mathematics > Probability & statistics
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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development (Paperback)
Loot Price: R1,419
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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development (Paperback)
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In response to the US FDA's Critical Path Initiative, innovative
adaptive designs are being used more and more in clinical trials
due to their flexibility and efficiency, especially during early
phase development. Handbook of Adaptive Designs in Pharmaceutical
and Clinical Development provides a comprehensive and unified
presentation of the principles and latest statistical methodologies
used when modifying trial procedures based on accrued data of
ongoing clinical trials. The book also gives a well-balanced
summary of current regulatory perspectives. The first several
chapters focus on the fundamental theory behind adaptive trial
design, the application of the Bayesian approach to adaptive
designs, and the impact of potential population shift due to
protocol amendments. The book then presents a variety of
statistical methods for group sequential design, classical design,
dose-finding trials, Phase I/II and Phase II/III seamless adaptive
designs, multiple stage seamless adaptive trial design, adaptive
randomization trials, hypotheses-adaptive design, and
treatment-adaptive design. It also covers predictive biomarker
diagnostics for new drug development, clinical strategies for
endpoint selection in translational research, the role of
independent data monitoring committees in adaptive clinical trials,
the enrichment process in targeted clinical trials for personalized
medicine, applications of adaptive designs that use genomic or
genetic information, adaptive trial simulation, and the efficiency
of adaptive design. The final chapters discuss case studies as well
as standard operating procedures for good adaptive practices. With
contributions from leading clinical researchers in the
pharmaceutical industry, academia, and regulatory agencies, this
handbook offers an up-to-date, complete treatment of the principles
and methods of adaptive design and analysis. Along with reviewing
recent developments, it examines issues commonly encountered when
applying adaptive design methods in clinical trials.
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