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Quantitative Evaluation of Safety in Drug Development - Design, Analysis and Reporting (Paperback)
Loot Price: R1,492
Discovery Miles 14 920
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Quantitative Evaluation of Safety in Drug Development - Design, Analysis and Reporting (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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State-of-the-Art Methods for Drug Safety Assessment Responding to
the increased scrutiny of drug safety in recent years, Quantitative
Evaluation of Safety in Drug Development: Design, Analysis and
Reporting explains design, monitoring, analysis, and reporting
issues for both clinical trials and observational studies in
biopharmaceutical product development. It presents the latest
statistical methods for drug safety assessment. The book's three
sections focus on study design, safety monitoring, and data
evaluation/analysis. The book addresses key challenges across
regulatory agencies, industry, and academia. It discusses
quantitative approaches to safety evaluation and risk management in
drug development, covering Bayesian methods, effective safety
graphics, and risk-benefit evaluation. Written by a team of
experienced leaders, this book brings the most advanced knowledge
and statistical methods of drug safety to the statistical,
clinical, and safety community. It shares best practices and
stimulates further research and methodology development in the drug
safety area.
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