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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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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
    • REFERENCES
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Keywords

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