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Quantitative Evaluation of Safety in Drug Development
Design, Analysis and Reporting
By: H. Amy Xia (Editor), Qi Jiang (Editor)
Paperback | 30 June 2020
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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.
ISBN: 9780367576004
ISBN-10: 0367576007
Series: Chapman & Hall/CRC Biostatistics Series
Published: 30th June 2020
Format: Paperback
Language: English
Number of Pages: 382
Audience: General Adult
Publisher: Taylor & Francis Ltd
Country of Publication: GB
Dimensions (cm): 23.4 x 15.6 x 2.29
Weight (kg): 0.45
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This product is categorised by
- Non-FictionMedicineMedicine in GeneralMedical Equipment & TechniquesMedical ResearchClinical Trials
- Non-FictionEngineering & TechnologyIndustrial Chemistry & Manufacturing TechnologiesIndustrial ChemistryPharmaceutical Technology
- Non-FictionMathematicsProbability & Statistics
- Non-FictionMedicineOther Branches of MedicinePharmacology
- Non-FictionMedicineNursing & Ancillary ServicesPharmacy & Dispensing
- Non-FictionScienceBiology, Life Sciences