[Dose finding for clinical trials of antiarrhythmic substances (author's transl)].
Specific difficulties connected with clinical evaluation and especially dose finding for antiarrhythmic substances are discussed. They are mainly due to the differences in pathogenesis, clinical significance and to the inconsistency of the symptom arrhythmia. Therefore special cardiologic skills are required for performance and interpretation of respective studies. The importance of selection of patients and determination of plasma levels of the substance is demonstrated. Possible procedures for determination of the therapeutic dosage are described and the necessity of detailed documentation of side effects is stressed.
D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000378:metabolism / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000188:drug therapy; D004341:Drug Evaluation / Q000379:methods; D006801:Humans; D007700:Kinetics
D000889:Anti-Arrhythmia Agents
Dosisfindung in der klinischen Prüfung von Antiarrhythmika