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Authors
Shen, Jim X. https://orcid.org/0000-0002-2000-598X
Dodge, Robert https://orcid.org/0000-0002-1513-2562
Oberstein, Shoshana https://orcid.org/0009-0008-7399-9907
Cunliffe, Jennifer https://orcid.org/0009-0008-3078-0454
Ramani, Varun https://orcid.org/0009-0004-0196-4626
Mohana Sundaram, Soumya https://orcid.org/0009-0007-0578-1933
Santos, Ines C. https://orcid.org/0000-0002-4609-7085
Yu, Chongwoo https://orcid.org/0009-0007-4133-898X
Dholakiya, Sanjay L. https://orcid.org/0000-0002-2894-085X
Kumar, Seema https://orcid.org/0000-0002-6845-3941
Xu, Xiaohui Sophia https://orcid.org/0000-0002-9255-1939
Fraser, Sasha https://orcid.org/0009-0009-1561-0737
Mokhtari, Zeinab https://orcid.org/0000-0002-6736-359X
Yin, Feng https://orcid.org/0000-0003-1655-3542
Rizzo, David G. https://orcid.org/0009-0006-7344-2717
Barnaby, Omar S. https://orcid.org/0009-0007-9832-0078
Shen, Honglue https://orcid.org/0009-0005-9021-9114
Warrino, Dominic E. https://orcid.org/0009-0002-8289-3852
Awasthi, Shivangi https://orcid.org/0000-0001-6739-4276
Burke, Krista https://orcid.org/0009-0002-1054-0628
Schaffer, Stephanie https://orcid.org/0009-0007-4096-2705
Rathi, Alok https://orcid.org/0009-0001-7295-8512
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Article History
Received: 2 January 2026
Accepted: 4 June 2026
First Online: 1 July 2026
Declarations
Conflict of Interest: The authors are employed by and receive compensation from their affiliations that are listed in this manuscript. The authors have no other relevant affiliations or financial involvements with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Disclaimer: Chongwoo Yu is an employee of the US FDA. The views expressed in this manuscript are his they do not reflect the official policy of the US FDA. No official endorsement by the US FDA is intended or should be inferred. The views and conclusions presented in this paper are those of the authors and do not reflect those affiliated company’s position on the subject.
