Evaluation of safety data from controlled clinical trials: The clinical principles explained

Drug Information Journal

Volumn 34, Issue 1, 2000, Pages 273-287

  Gait, John E ^a   Smith, Sandy ^a   Brown, Sherri L ^a  

^a AMGEN INC   (United States)

Author keywords

Adverse event; Bias; Cumulative probability; Exposure; Laboratory data

Indexed keywords

DRUG;

ARTHRALGIA; ARTICLE; BLOOD CLOTTING DISORDER; DRUG MANUFACTURE; DRUG SURVEILLANCE PROGRAM; EDEMA; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; PREVALENCE; PRIORITY JOURNAL; RISK ASSESSMENT; THORAX PAIN;

EID: 0034045316     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400135     Document Type: Article

References (3)

1. International Conference on Harmonization Definitions and Standards for Expedited Reporting. Federal Register. 1998;63:N0.10:2396-2404.
2. White CA. A preliminary assessment of the impact of MEDDRA on adverse event reports and product labeling. Drug Inf J. 1998;32:347-362.
3. International Conference on Harmonization: Guidance on Statistical Principles for Clinical Trials. Federal Register. 1998;63, No. 179:49583-49598.