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Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics
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Theory of Drug Development (Paperback)
Loot Price: R2,015
Discovery Miles 20 150
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Theory of Drug Development (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Theory of Drug Development presents a formal quantitative framework
for understanding drug development that goes beyond simply
describing the properties of the statistics in individual studies.
It examines the drug development process from the perspectives of
drug companies and regulatory agencies. By quantifying various
ideas underlying drug development, the book shows how to
systematically address problems, such as: Sizing a phase 2 trial
and choosing the range of p-values that will trigger a follow-up
phase 3 trial Deciding whether a drug should receive marketing
approval based on its phase 2/3 development program and recent
experience with other drugs in the same clinical area Determining
the impact of adaptive designs on the quality of drugs that receive
marketing approval Designing a phase 3 pivotal study that permits
the data-driven adjustment of the treatment effect estimate Knowing
when enough information has been gathered to show that a drug
improves the survival time for the whole patient population Drawing
on his extensive work as a statistician in the pharmaceutical
industry, the author focuses on the efficient development of drugs
and the quantification of evidence in drug development. He provides
a rationale for underpowered phase 2 trials based on the notion of
efficiency, which leads to the identification of an admissible
family of phase 2 designs. He also develops a framework for
evaluating the strength of evidence generated by clinical trials.
This approach is based on the ratio of power to type 1 error and
transcends typical Bayesian and frequentist statistical analyses.
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