Description
Quantitative Evaluation of Safety in Drug Development
Design, Analysis and Reporting
Chapman & Hall/CRC Biostatistics Series
Coordinators: Jiang Qi, Xia H. Amy
Language: EnglishSubjects for Quantitative Evaluation of Safety in Drug Development:
Keywords
Self-controlled Case Series; Standardize MedDRA Query; clinical trials in biopharmaceutical product development; Data Monitoring Committee; observational studies in biopharmaceutical product development; Non-inferiority Trials; statistical methods for drug safety assessment; Network Meta-analysis Models; safety evaluation and risk management in drug development; Noninferiority Trial; Bayesian methods; Random Effects Model; safety of biopharmaceutical products; Ich E10; DMC safety report; Interim Analyses; observational medical outcomes partnership (OMOP); Nonsteroidal Anti-inammatory Drug; meta-analysis of safety data; Condence Intervals; safety surveillance; OMOP; Signal Detection; Observational Database Studies; Independent Studies; Drug Event Combinations; Ich S9; Super Learner; Van Der Laan; QALY Loss; Detecting Safety Signals; MCDA Approach; Nonsteroidal Antiinammatory Drug; SMAA; Qt Prolongation
Publication date: 06-2020
· 15.6x23.4 cm · Paperback
Publication date: 12-2014
· 15.6x23.4 cm · Hardback
Description
/li>Contents
/li>Biography
/li>
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.
Study Design. Safety Monitoring. Evaluation/Analysis. Index.
Qi Jiang, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Jiang is a fellow of the American Statistical Association, a member of many industry-wide initiatives, and an associate editor of the journal Statistics in Biopharmaceutical Research (SBR). She has over 18 years of clinical trial experience in early and late clinical development phases across a broad spectrum of therapeutic areas. Her research interests include drug safety monitoring and analyses, benefit-risk assessment, clinical meaningfulness, dichotomization, meta-analyses, network meta-analysis, adaptive design, and non-inferiority study design and analyses.
H. Amy Xia, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Xia is a member of many industry-wide initiatives. In the past 18 years, she has worked on designing, executing, and reporting clinical trials as well as observational studies for developing pharmaceutical and medical device products in a wide range of different disease areas. Her research interests include safety biostatistics, signal detection, Bayesian design, monitoring and analysis of clinical trials, meta-analysis, and adaptive design.