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design, analysis and reporting

"Quantitative evaluation of safety in drug development" was published by CRC Press, Taylor & Francis Group in 2015 - Boca Raton, it has 349 pages and the language of the book is English.


“Quantitative evaluation of safety in drug development” Metadata:

  • Title: ➤  Quantitative evaluation of safety in drug development
  • Authors:
  • Language: English
  • Number of Pages: 349
  • Publisher: ➤  CRC Press, Taylor & Francis Group
  • Publish Date:
  • Publish Location: Boca Raton

“Quantitative evaluation of safety in drug development” Subjects and Themes:

Edition Specifications:

  • Pagination: xv, 349 pages

Edition Identifiers:

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"Quantitative evaluation of safety in drug development" Table Of Contents:

  • 1- Incorporating quantitative safety evaluation into risk management / Jüergen Küebler
  • 2- Bayesian metaexperimental design for evaluating cardiovascular risk / Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu and Violeta Hennessey
  • 3- Non-inferiority study design and analysis for safety endpoints / /Steven Snapinn and Qi Jiang
  • 4- Program safety analysis plan : an implementation guide / Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang
  • 5- Why a DMC safety report differs from a safety section written at the end of the trial / Mark Schactman and Janet Wittes
  • 6- Safety surveillance and signal detection process / Atsuko Shibata and José M. Vega
  • 7- Bayesian adaptive trials for drug safety / Jason T. Connor
  • 8- Observational safety study design, analysis, and reporting / Hong Qiu, Jesse A. Berlin, and Paul E. Stang
  • 9- Emerging role of observational health-care data in pharmacovigilance / Patrick Ryan, David Madigan, and Martijn Schuemie
  • 10- Roadmap for causal inference in safety analysis / Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan
  • 11- Safety graphics / Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny
  • 12- Bayesian network meta-analysis for safety evaluation / Bradley P. Carlin and Hwanhee Hong
  • 13- Regulatory issues in meta-analysis of safety data / Aloka G. Chakravarty and Mark Levenson
  • 14- Bayesian applications for drug safety evaluation / H. Amy Xia and Karen L. Price
  • 15- Benefit-risk assessment approaches / Chunlei Ke, Qi Jiang, and Steven Snapinn
  • 16- Detecting safety signals in subgroups / Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama and Kazuhiko Kuribayashi
  • 17- Overview of safety evaluation and quantitative approaches from preclinical and early phases of drug development / John Sullivan and Hisham Hamadeh.

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