عنوان

Quantitative evaluation of safety in drug development :

شابک

1466555475

شابک

9781466555471

شماره

b573482

عنوان اصلي

Quantitative evaluation of safety in drug development :

نام عام مواد

[Book]

ساير اطلاعات عنواني

design, analysis and reporting

نام نخستين پديدآور

[edited by] Qi Jiang, H. Amy Xi.

محل نشرو پخش و غیره

Boca Raton, Florida

نام ناشر، پخش کننده و غيره

Taylor & Francis

تاریخ نشرو بخش و غیره

2015

عنوان فروست

Chapman & Hall/CRC biostatistics series.

متن يادداشت

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

موضوع مستند نشده

Drugs -- Testing.

موضوع مستند نشده

MEDICAL -- Pharmacology.

موضوع مستند نشده

Pharmaceutical arithmetic.

مستند نام اشخاص تاييد نشده

[edited by] Qi Jiang, H. Amy Xi.

مستند نام اشخاص تاييد نشده

H Amy Xia

مستند نام اشخاص تاييد نشده

Qi Jiang, (Biostatistician)

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y