Table of Contents
NDA 21-242 Rectal Artesunate
Proposed Indication
Implications of the Indication
SAFETY SUBMISSIONS
WHO-sponsored Studies
WHO-sponsored Studies
WHO-sponsored Studies: Clinical
WHO-sponsored Studies: AE
WHO-sponsored studies: Deaths
WHO-sponsored Studies: Labs
WHO-sponsored studies : Dose
WHO-sponsored Studies: Special Populations
WHO-sponsored Studies: Safety Summary
Safety Review of Published and Unpublished Clinical Studies on Artemisinin Derivatives
WHO- Safety Review: Types of Clinical Studies
WHO-Safety Review: Disease Population
WHO-Safety Review: Adverse Events
WHO-Safety Review: Laboratory and ECG Abnormalities
WHO-Safety Review: Neurological Assessments
WHO-Safety Review: reassurance
WHO-Safety Review: problems
Artemisinin Neurotoxicity
Preclinical evidence: neurotoxicity margin of safety
Preclinical evidence: margin of safety
Neurotoxicity: clinical experience
Neurotoxicity: What do we know
Neurotoxicity: What we don’t know
Lack of information: populations Can we make the link?
Safety Summary: Benefit / Risk
Safety Summary: Benefit/Risk
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