Garcia, M. Iveth https://orcid.org/0000-0002-7191-4761
Dame, Keri
Charwat, Verena
Siemons, Brian A.
Finsberg, Henrik https://orcid.org/0000-0003-3766-2393
Bhardwaj, Bhavya
Yokosawa, Ryosuke
Goswami, Ishan
Bruckner, Dylan
Wall, Samuel T.
Ford, Kevin A.
Healy, Kevin E. https://orcid.org/0000-0002-8524-3671
Ribeiro, Alexandre J. S. https://orcid.org/0009-0004-3421-2527
Article History
Received: 10 April 2024
Accepted: 26 February 2025
First Online: 7 April 2025
Competing interests
: Work for the manuscript was completed by A.J.S.R., K.D., and R.Y. while employees of the FDA. A.J.S.R is currently employed by Hovione PharmaScience Ltd. K.D. is currently employed by United Therapeutics Corporation. R.Y. is currently part of the Department of Biomedical Engineering and Mechanics at Virginia Polytechnic Institute and State University. K.E.H., V.C., S.T.W., H.F. and B.A.S. have either a financial or equity relationship with Organos Inc. and both they and the company may benefit from commercialization of the results of this research. All other authors declare that they have no competing financial interests and that the article reflects the views of the authors and should not be construed to represent the FDA’s views or policies.