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Research ArticleThe State of the Art
Open Access

68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership

Giuseppe Carlucci, Robin Ippisch, Roger Slavik, Ashley Mishoe, Joseph Blecha and Shaojun Zhu
Journal of Nuclear Medicine February 2021, 62 (2) 149-155; DOI: https://doi.org/10.2967/jnumed.120.260455
Giuseppe Carlucci
1Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and
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Robin Ippisch
2Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California
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Roger Slavik
1Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and
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Ashley Mishoe
2Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California
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Joseph Blecha
2Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California
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Shaojun Zhu
1Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and
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Article Information

vol. 62 no. 2 149-155
DOI 
https://doi.org/10.2967/jnumed.120.260455
PubMed 
33443068

Published By 
Society of Nuclear Medicine
Print ISSN 
0161-5505
Online ISSN 
2159-662X
History 
  • Received for publication November 20, 2020
  • Accepted for publication December 16, 2020
  • Published online January 19, 2021.

Article Versions

  • previous version (December 18, 2020 - 14:27).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© 2021 by the Society of Nuclear Medicine and Molecular Imaging. Immediate Open Access: Creative Commons Attribution 4.0 International License (CC BY) allows users to share and adapt with attribution, excluding materials credited to previous publications. License: https://creativecommons.org/licenses/by/4.0/. Details: http://jnm.snmjournals.org/site/misc/permission.xhtml.

Author Information

  1. Giuseppe Carlucci1,
  2. Robin Ippisch2,
  3. Roger Slavik1,
  4. Ashley Mishoe2,
  5. Joseph Blecha2 and
  6. Shaojun Zhu1
  1. 1Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and
  2. 2Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California
  1. For correspondence or reprints contact: Shaojun Zhu, University of California, Los Angeles, 650 Charles E Young Dr. South, CHS 23-170, Los Angeles, CA 90095. E-mail: szhu{at}mednet.ucla.edu
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Article usage: December 2020 to February 2021

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Jan 2021477492557
Feb 2021587416197
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Journal of Nuclear Medicine: 62 (2)
Journal of Nuclear Medicine
Vol. 62, Issue 2
February 1, 2021
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68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership
Giuseppe Carlucci, Robin Ippisch, Roger Slavik, Ashley Mishoe, Joseph Blecha, Shaojun Zhu
Journal of Nuclear Medicine Feb 2021, 62 (2) 149-155; DOI: 10.2967/jnumed.120.260455

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68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership
Giuseppe Carlucci, Robin Ippisch, Roger Slavik, Ashley Mishoe, Joseph Blecha, Shaojun Zhu
Journal of Nuclear Medicine Feb 2021, 62 (2) 149-155; DOI: 10.2967/jnumed.120.260455
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  • Article
    • Abstract
    • PART I: 68GA-PSMA-11 DEVELOPMENT AND REGULATORY APPROVAL PROCESS
    • PART II: KEY CMC INFORMATION FOR 68GA-PSMA-11
    • CONCLUSION
    • DISCLOSURE
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Keywords

  • Oncology: GU
  • PET/CT
  • radiochemistry
  • Radiopharmaceuticals
  • 68Ga-PSMA-11
  • approval
  • FDA
  • new drug application
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