In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing bioequivalence for a locally acting drug product delive...

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Detalles Bibliográficos
Autores principales: Walenga, Ross L., Babiskin, Andrew H., Zhao, Liang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618094/
https://www.ncbi.nlm.nih.gov/pubmed/31044532
http://dx.doi.org/10.1002/psp4.12413
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author Walenga, Ross L.
Babiskin, Andrew H.
Zhao, Liang
author_facet Walenga, Ross L.
Babiskin, Andrew H.
Zhao, Liang
author_sort Walenga, Ross L.
collection PubMed
description The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing bioequivalence for a locally acting drug product delivered to the site of action in the lung. This review examines in silico models that may be used to support the development of generic orally inhaled drug products and how model credibility may be assessed.
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spelling pubmed-66180942019-07-16 In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products Walenga, Ross L. Babiskin, Andrew H. Zhao, Liang CPT Pharmacometrics Syst Pharmacol Reviews The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing bioequivalence for a locally acting drug product delivered to the site of action in the lung. This review examines in silico models that may be used to support the development of generic orally inhaled drug products and how model credibility may be assessed. John Wiley and Sons Inc. 2019-05-21 2019-06 /pmc/articles/PMC6618094/ /pubmed/31044532 http://dx.doi.org/10.1002/psp4.12413 Text en © 2019. This article is a U.S. Government work and is in the public domain in the USA. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Reviews
Walenga, Ross L.
Babiskin, Andrew H.
Zhao, Liang
In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title_full In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title_fullStr In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title_full_unstemmed In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title_short In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
title_sort in silico methods for development of generic drug–device combination orally inhaled drug products
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6618094/
https://www.ncbi.nlm.nih.gov/pubmed/31044532
http://dx.doi.org/10.1002/psp4.12413
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