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Characterization of Encapsulated Liposomal Irinotecan

Published online by Cambridge University Press:  05 August 2019

Jade M. Noble ,
Lynn Chen ,
Rajan Jog ,
Darby Kozak  and
Jiwen Zheng
Jade M. Noble
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, United States
Lynn Chen
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, United States
Rajan Jog
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States
Darby Kozak
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States
Jiwen Zheng
Affiliation:
Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, United States

Abstract

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Type
Pharmaceuticals FIG – Imaging, Analysis, and Regulation of Medical Products, Devices and Data Integrity
Information
Microscopy and Microanalysis , Volume 25 , Supplement S2 , August 2019 , pp. 1274 - 1275
Copyright
Copyright © Microscopy Society of America 2019 

References

[1]Li, T, et al. , J. Control. Release 288 (2018), p. 96.Google Scholar
[2]Nag, OK and Awashti, V, Pharmaceutics 5 (2013), p. 542.Google Scholar
[3]Noble, CO, Kirpotin, DB, Hayes, ME, Mamot, C, Hong, K, Park, JW, Benz, CC, Marks, JD and Drummond, DC, Expert Opinion on Therapeutic Targets 8 (2004), p. 335.Google Scholar
[4]U.S. Food and Drug Administration. “Draft Guidance on Doxorubicin Hydrochloride.” https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM19 9635.pdf (Accessed 02.01.19).Google Scholar
[5]Drs. Noble and Jog, as well as L. Chen were supported in part by an appointment to the Research Participation Program at the Center for Drug Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA. The authors would like to acknowledge the Advanced Characterization Facility at the FDA and CDRH/OSEL/DBCMS and CDER/OPQ/OTR for instrument use.Google Scholar