Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (chapman & Hall/crc Biostatistics Series)
by Qi Jiang /
2014 / English / PDF
6.6 MB Download
State-of-the-Art Methods for Drug Safety Assessment
State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent
years,
Responding to the increased scrutiny of drug safety in recent
years,Quantitative Evaluation of Safety in Drug
Development: Design, Analysis and Reporting
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.
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.
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.
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.
