Preparing for safety issues following drug approval: Pre-approval risk management considerations

Therapeutic Advances in Drug Safety

Volumn 4, Issue 5, 2013, Pages 220-228

  Dieck, Gretchen S ^a   Sharrar, Robert G ^a  

^a UNITED BIOSOURCE CORPORATION   (United States)

Author keywords

postapproval; pre approval; risk management; risk mitigation; safety

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; BUDESONIDE PLUS FORMOTEROL; CLOZAPINE; HALOPERIDOL; INDACATEROL; OLANZAPINE; RISPERIDONE; SEROTONIN UPTAKE INHIBITOR; TELAVANCIN; THIORIDAZINE; ZIPRASIDONE;

ARTICLE; BIRTH CONTROL; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CERTIFICATION; CLINICAL TRIAL (TOPIC); DISEASE REGISTRY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG MEGADOSE; DRUG SAFETY; ELECTRONIC MEDICAL RECORD; GALLBLADDER DISEASE; HEALTH EDUCATION; HEART ARREST; HEART VENTRICLE ARRHYTHMIA; HUMAN; MEDICAID; MEDICAL SOCIETY; MORBIDITY; NEUROPATHIC PAIN; OVERACTIVE BLADDER; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; QT PROLONGATION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SCHIZOPHRENIA; SUDDEN DEATH; TORSADE DES POINTES; UNITED STATES; WEIGHT GAIN;

EID: 84890220859     PISSN: 20420986     EISSN: 20420994     Source Type: Journal    
DOI: 10.1177/2042098613498091     Document Type: Review

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