Areas Without Adequate Human Evidence Cardiovascular safety Neurological and psychiatric effects Liver and kidney safety Effects on blood glucose in humans Effects on methylation pathways Genotoxicity Carcinogenicity Reproductive and developmental toxicity Use during pregnancy or breastfeeding Interactions with prescription medicines Interactions with supplements or research compounds Long-term exposure Product-Quality Risks Incorrect quinolinium compound Wrong substitution position Incorrect counterion Incorrect active-content calculation Residual starting materials Residual solvents Degradation products Heavy-metal or inorganic contamination Mismatched certificate of analysis Uncontrolled storage and transport Absence of published harm is not proof of safety A compound without routine regulated human exposure may generate very few formal safety reports simply because there is no organised pharmacovigilance system
In general, drugs should cost under $100,000 or $150,000 per QALY to be considered cost effective
Diabetes 4 , 190201 (2013)
Biochemistry 31, 25822587
Retrieved from Office of the Assistant Secretary for Planning and Evaluation (ASPE)
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