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

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 ses...

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Bibliographic Details
Main Authors: Ross L. Walenga (Author), Clare Butler (Author), Brent A. Craven (Author), P. Worth Longest (Author), Raja Mohamed (Author), Bryan Newman (Author), Bo Olsson (Author), Günther Hochhaus (Author), Bing V. Li (Author), Markham C. Luke (Author), Liang Zhao (Author), Andrzej Przekwas (Author), Robert Lionberger (Author)
Format: Book
Published: Wiley, 2023-05-01T00:00:00Z.
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Summary: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.
Item Description:2163-8306
10.1002/psp4.12889

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