Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
Ross Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger
Abstract
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States. This review summarizes the presentations and panel discussion that comprised a workshop session concentrated on the use of in silico models to predict various outcomes following orally inhaled drug product administration, including the status of such models and how model credibility may be effectively established.
Topics & Concepts
CredibilityIn silicoSession (web analytics)DrugMedicinePharmacologyComputer scienceRisk analysis (engineering)Intensive care medicineChemistryPolitical scienceWorld Wide WebBiochemistryGeneLawInhalation and Respiratory Drug DeliveryDrug Solubulity and Delivery Systems