QUANTITATIVE EVALUATION OF SAFETY IN DRUG DEVELOPMENT: DESIGN, ANALYSIS AND REPORTING (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) FROM CHAP

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QUANTITATIVE EVALUATION OF SAFETY IN DRUG DEVELOPMENT: DESIGN, ANALYSIS AND REPORTING (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) FROM CHAP PDF

It is not secret when linking the composing skills to reading. Reading Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap will certainly make you obtain more sources and sources. It is a manner in which could boost just how you ignore and also understand the life. By reading this Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap, you could more than just what you obtain from various other book Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap This is a popular publication that is published from renowned publisher. Seen kind the author, it can be trusted that this publication Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap will provide lots of inspirations, about the life as well as encounter as well as every little thing inside.

About the Author 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 metaanalysis, 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.

QUANTITATIVE EVALUATION OF SAFETY IN DRUG DEVELOPMENT: DESIGN, ANALYSIS AND REPORTING (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) FROM CHAP PDF

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QUANTITATIVE EVALUATION OF SAFETY IN DRUG DEVELOPMENT: DESIGN, ANALYSIS AND REPORTING (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) FROM CHAP PDF

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.

● ● ● ● ● ● ●

Sales Rank: #1963494 in Books Published on: 2014-12-08 Original language: English Number of items: 1 Dimensions: 9.10" h x 1.00" w x 6.10" l, .0 pounds Binding: Hardcover 382 pages

About the Author 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 metaanalysis, 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.

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QUANTITATIVE EVALUATION OF SAFETY IN DRUG DEVELOPMENT: DESIGN, ANALYSIS AND REPORTING (CHAPMAN & HALL/CRC BIOSTATISTICS SERIES) FROM CHAP PDF

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It is not secret when linking the composing skills to reading. Reading Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap will certainly make you obtain more sources and sources. It is a manner in which could boost just how you ignore and also understand the life. By reading this Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap, you could more than just what you obtain from various other book Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting (Chapman & Hall/CRC Biostatistics Series) From Chap This is a popular publication that is published from renowned publisher. Seen kind the author, it can be trusted that this publication Quantitative Evaluation Of Safety In Drug Development: Design, Analysis And Reporting

(Chapman & Hall/CRC Biostatistics Series) From Chap will provide lots of inspirations, about the life as well as encounter as well as every little thing inside.

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