Regulatory issues for Data and Safety Monitoring Committees

American Heart Journal

Volumn 141, Issue 4, 2001, Pages 536-541

  Fisher, Lloyd ^a   Klibaner, Michael ^b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; CONFERENCE PAPER; GOOD CLINICAL PRACTICE; HEALTH CARE POLICY; MEDICAL INFORMATION; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; SAFETY;

EID: 0035091717     PISSN: 00028703     EISSN: None     Source Type: Journal    
DOI: 10.1067/mhj.2001.113839     Document Type: Conference Paper

References (22)

1. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use
2. Carvedilol and the Food and Drug Administration (FDA) approval process: The FDA paradigm and reflections on hypothesis testing
3. Carvedilol and the Food and Drug Administration approval process: An introduction
4. Carvedilol and the Food and Drug Administration approval process: A brief response to Professor Moyé's article
5. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF)
6. The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF)
7. Final report on the aspirin component of the ongoing Physicians' Health Study
8. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization
9. Effectiveness of early coronary angioplasty and abciximab for failed thrombolysis (reteplase or alteplase) during acute myocardial infarction (results from the GUSTO-III trial): Global use of strategies to open occluded coronary arteries
10. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
11. Sponsors lose fight to stop thyroxine study publication