Guidelines for the clinical evaluation of anti-arrhythmic drugs
United States. Food and Drug Administration, United States. Food and Drug Administration. Bureau of Drugs
Dept. of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1977 - Arrhythmia - 7 pages
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acceptable current approaches acute arrhythmias Adequate numbers Adults and Children and/or Anesthetics FDA anti-arrhythmic agents anti-arrhythmic drugs appropriate number atrial biotransformation Bureau of Drugs cardiac arrhythmias classes of drugs Clinical Evaluation clinical guidelines clinical trials Committee on Drugs conclusions concerning safety congestive heart failure controlled studies determining digitalis dosage doses double-blind Drug Administration drug effects drug's Drugs Adults Drugs FDA Drugs in Infants duration of anti-arrhythmic Early Phase electrocardiographic tape recordings electrolyte electrophysiologic EVALUATION OF ANTI-ARRHYTHMIC Evaluation of Drugs experience with available FDA's Advisory Committees Food and Drug hemodynamic hypotension indicated Infants and Children initial investigational drugs Late Phase left ventricular metabolic studies monitoring myocardial number of subjects obtained during Phase oral and parenteral outpatients parenteral routes pediatric guidelines Pharmacodynamic placebo plasma levels potential present acceptable current refractory period renal repeated administration routes of administration specific classes suitable laboratory tests therapeutic Types of Patients vascular resistance views of outstanding