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Scientific Considerations for an In Vitro Bioequivalence Approach for Ultrasound Contrast Agent Products: How Size Distribution and Total Volume of Microbubbles Affect Its Echogenicity

Published online by Cambridge University Press:  01 August 2018

Bonhye Koo ,
Bin Qin ,
Yunbo Liu ,
Yong Wu ,
Stephanie Choi ,
Darby Kozak  and
Jiwen Zheng
Bonhye Koo
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD20993, United States Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD20993, United States
Bin Qin
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD20993, United States
Yunbo Liu
Affiliation:
Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland20993, United States
Yong Wu
Affiliation:
Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD20993, United States
Stephanie Choi
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD20993, United States
Darby Kozak
Affiliation:
Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD20993, United States
Jiwen Zheng
Affiliation:
Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD20993, United States

Abstract

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Type
Abstract
Information
Microscopy and Microanalysis , Volume 24 , Supplement S1: Proceedings of Microscopy & Microanalysis 2018 , August 2018 , pp. 1428 - 1429
Copyright
© Microscopy Society of America 2018 

References

[1] Gorce, J-M, Arditi, M Schneider, M Investigative Radiology 35 2000) p. 661–671.Google Scholar
[2] The authors (Bonhye Koo and Bin Qin) are supported in part by an appointment to the Oak Ridge Institute for Science and Education (ORISE) research participation program at the Center for Drug Evaluation and Research (CDER) administered by the ORISE through an agreement between the U.S. Department of Energy and CDER.Google Scholar
[3] The authors would like to acknowledge the FDA Advanced Characterization Facility, Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of Biotechnology Products/Division of Biotechnology Review and Research II, Center for Devices and Radiological Health/Office of Science and Engineering Laboratories/Division of Applied Mechanics, and Center for Devices and Radiological Health/Office of Science and Engineering Laboratories/Division of Biology, Chemistry, and Material Science for instrument use..Google Scholar