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

Autor: 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
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 560-574 (2023)
Druh dokumentu: article
ISSN: 2163-8306
DOI: 10.1002/psp4.12889
Popis: 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.
Databáze: Directory of Open Access Journals
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