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Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

Year: 2022
Type: review
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.
DOI: 10.1002/psp4.12889
Authors: Ross L. 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
Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research, Teva Pharmaceuticals (Ireland), Center for Devices and Radiological Health, Virginia Commonwealth University, University of Florida, CFD Research Corporation (United States)
Language: English
Field: Medicine
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W4308186060
FWCI: 0.736
Cites: 58
Cited by: 19
Related to: 10