E N D Presentation Transcript FDA Inspection Common Deficiencies Inadequate consent 51% Protocol Non-adherence 31% Records Inadequate/Inaccurate 26% Drug Accountability Inadequate 20% IRB deficiencies 11% Investigator Failure to report Adverse Events Reporting of Adverse Events An Adverse Event (AE) is any untoward medical occurrence in a subject administered a drug (biologic, device)
6 The solution should be clear
The risk is dose-dependent and increases with prolonged use, advanced age, concurrent corticosteroid or anticoagulant use, and history of peptic ulcer disease
1 (panel A), free GSH disappeared within a minute after the addition of TNBS, resulting in a complex HPLC pattern showing additional molecular forms (panel B), including the formation of TNB-GSH adducts
If you have conditions like high blood pressure, liver problems, or kidney disease, your doctor might need to adjust your medication plan
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