Bernstein, James
Huynh-Ba, Kim
Lynch, Patrick
Oliver, Thomas
Oliyai, Reza
Roberts, Scott W. http://orcid.org/0000-0001-8963-3282
Schirmer, Andrea
Schwinke, David
Tang, Kin
Ursin, Jessica
Article History
Received: 14 November 2023
Accepted: 15 December 2023
First Online: 4 March 2024
Declarations
:
: Not applicable.
: The authors declare no competing interests.
: No funding was granted for the preparation or authorship of this article. However, this publication received a publication waiver from AAPS Open.
: The authoring team would like to thank Cheenu Murti and Karen Pica from the AAPS CMC Community for their support of this manuscript. The authors would also like to thank the FDAs OPQ and OBP policy reviewers for their careful review and comments.
: This article reflects the views of the author and should not be construed to represent FDA’s views or policies. The views expressed in this article additionally do not necessarily reflect the opinions of author companies/institutions.
: Not applicable.
: Not applicable.