Abstract
Predicting potential toxicologic responses to transdermal delivery is a complex procedure, involving both traditional toxicology protocols for evaluating results of systemic exposure and topical studies assessing skin-drug interactions and reactions. Evaluation of individual drug and system components is followed by final system testing to assess possible interactions. Risk is estimated by analyzing toxicologic data quantitatively, with estimation of human exposure based on dose-response extrapolations. Formulation or system changes designed to minimize risk are evaluated. In some instances local intolerance to a compound—due either to irritation or sensitization—may preclude development of a successful transdermal product despite efficacious plasma levels. For viable projects with acceptable toxicologic profiles, a strategy is implemented to manage risk of irritation and sensitization. In addition to the usual drug-specific systemic toxicology and regulatory issues, a toxicology evaluation plan for trans...
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