1. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2017 Subject(s): Arrhythmias, Cardiac -- chemically inducedArrhythmias, Cardiac -- diagnosisCardiac Electrophysiology -- methodsCardiac Electrophysiology -- standardsDrug ApprovalElectrocardiography -- standardsLong QT Syndrome -- chemically inducedCardiotoxinsClinical Trials as TopicCongresses as TopicDiagnosis, Computer-AssistedDrug-Related Side Effects and Adverse ReactionsInternational CooperationPharmaceutical Preparations -- administration & dosageReference StandardsResearch DesignSex FactorsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023 Subject(s): Drug ContaminationDrug IndustryDrug-Related Side Effects and Adverse ReactionsEthylene GlycolsGlycerolGovernment RegulationPropylene GlycolSorbitolUnited States
