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Quantitative Evaluation of Safety in Drug Development

By Xia, H. Amy

Product Image: Quantitative Evaluation of Safety in Drug Development

Quantitative Evaluation of Safety in Drug Development

By Xia, H. Amy

0 - Default Title
Description
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 explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. 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.
Product details
Edition:
1
Number of Pages:
382
Release Date:
2014-12-11
Publication Date:
2014-12-08
Publisher:
Chapman and Hall/CRC
Languages:
Original: English
ISBN10:
1466555459
ISBN13:
9781466555457
GPSR Manufacturer Reference:
[email protected]
Weight:
737 g
Height:
161 cm
Width:
240 cm
Thickness:
25 cm
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