4.1 Article

The Practice of Pre-Marketing Safety Assessment in Drug Development

Related references

Note: Only part of the references are listed.
Review Medicine, Research & Experimental

Planning and core analyses for periodic aggregate safety data reviews

H. Amy Xia et al.

CLINICAL TRIALS (2011)

Article Pharmacology & Pharmacy

BAYESIAN HIERARCHICAL MODELING FOR DETECTING SAFETY SIGNALS IN CLINICAL TRIALS

H. Amy Xia et al.

JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2011)

Article Medicine, Research & Experimental

Evaluating the safety of a rotavirus vaccine: the REST of the story

Joseph F. Heyse et al.

CLINICAL TRIALS (2008)

Article Health Care Sciences & Services

Measures for conducting comparative benefit: Risk assessment

Christy Chuang-Stein et al.

DRUG INFORMATION JOURNAL (2008)

Article Medicine, General & Internal

HLA-B*5701 screening for hypersensitivity to abacavir

Simon Mallal et al.

NEW ENGLAND JOURNAL OF MEDICINE (2008)

Article Public, Environmental & Occupational Health

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project

Andrew J. P. Cooper et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2008)

Article Pharmacology & Pharmacy

Graphical approaches to the analysis of safety data from clinical trials

Ohad Amit et al.

PHARMACEUTICAL STATISTICS (2008)

Article Medicine, General & Internal

Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine

T Vesikari et al.

NEW ENGLAND JOURNAL OF MEDICINE (2006)

Article Medicine, General & Internal

Forest plots: trying to see the wood and the trees

S Lewis et al.

BMJ-BRITISH MEDICAL JOURNAL (2001)

Article Health Care Sciences & Services

Recent advancements in the analysis and presentation of safety data

C Chuang-Stein et al.

DRUG INFORMATION JOURNAL (2001)