In Silico Methods for Development of Generic Drug-Device Combination Orally Inhaled Drug Products.
| Autor: | Walenga RL; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Babiskin AH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. |
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| Jazyk: | angličtina |
| Zdroj: | CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2019 Jun; Vol. 8 (6), pp. 359-370. Date of Electronic Publication: 2019 May 21. |
| DOI: | 10.1002/psp4.12413 |
| Abstrakt: | 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. (© 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.) |
| Databáze: | MEDLINE |
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