Study record · KPV
FDA evidence audit: KPV human exposure
FDA states it has not identified human exposure data on drug products containing KPV by any route.
Key result
FDA states it has not identified human exposure data on drug products containing KPV by any route.
Study details
Study designRegulatory evidence review / no human exposure identified
PopulationNo human drug-product exposure identified
RouteAny
Regimen / exposureNot applicable
DurationNot applicable
ComparatorNot applicable
Primary endpoint / questionExistence of human exposure and safety data
Safety resultHuman therapeutic safety is unknown.
Key limitationsCell and animal studies are not evidence of human drug exposure.
Registry / identifierFDA compounding safety review