Carvedilol and the food and drug administration approval process: An Introduction

Controlled Clinical Trials

Volumn 20, Issue 1, 1999, Pages 1-15

  Fisher, Lloyd D ^a,b   Moyé, Lemuel A ^a,b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Advisory committee; Alpha blocker; Antioxidant; Beta blocker; Carvedilol; FDA; Randomized clinical trial

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; CARVEDILOL; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; NEW DRUG;

ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DRUG APPROVAL; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HEART LEFT VENTRICLE FAILURE; HUMAN; HYPERTENSION; MORTALITY; STANDARD;

ADRENERGIC ALPHA-ANTAGONISTS; ADRENERGIC BETA-ANTAGONISTS; CARBAZOLES; DRUG APPROVAL; HEART FAILURE, CONGESTIVE; HUMANS; PROPANOLAMINES; PUBLIC POLICY; RANDOMIZED CONTROLLED TRIALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033011501     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(98)00052-X     Document Type: Article

References (2)

1. Fisher L.D. Carvedilol and the Food and Drug Administration (FDA) approval process. the FDA paradigm and reflections upon hypothesis testing Controlled Clin Trials. 20:1999;16-39.
2. Moyé L. Endpoint interpretation in clinical trials. the case for discipline Controlled Clin Trials. 20:1999;40-49.