عنوان

Quantitative evaluation of safety in drug development :

(Number (ISBN

1466555475

(Number (ISBN

9781466555471

Number

b573482

Title Proper

Quantitative evaluation of safety in drug development :

General Material Designation

[Book]

Other Title Information

design, analysis and reporting

First Statement of Responsibility

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

Place of Publication, Distribution, etc.

Boca Raton, Florida

Name of Publisher, Distributor, etc.

Taylor & Francis

Date of Publication, Distribution, etc.

2015

Series Title

Chapman & Hall/CRC biostatistics series.

Text of Note

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.

Drugs -- Testing.

MEDICAL -- Pharmacology.

Pharmaceutical arithmetic.

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

H Amy Xia

Qi Jiang, (Biostatistician)

Electronic name

[Book]

Y