Genis-Najera, Luis http://orcid.org/0009-0009-9190-4286
Sañudo-Maury, Maria Elena http://orcid.org/0000-0002-8463-462X
Funding for this research was provided by:
Sanofi, S.A. de C.V., Mexico
Article History
Received: 26 August 2023
Accepted: 13 November 2023
First Online: 2 December 2023
Declarations
:
: Luis Genis-Najera and Maria Elena Sañudo-Maury are employees of Sanofi and may own shares and/or stocks in the company. The authors declare no other conflicts of interest relevant to this study.
: This study was performed in compliance with the principles of the Declaration of Helsinki, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS – Federal Committee for Protection from Sanitary Risks) regulatory requirements, the Mexican guidance NOM 177-SSA1-2013 that establishes the requirements for bioequivalence studies, and the Mexican Regulation of the General Health Law Regarding Health Research. The study protocol (213301410B0051) was approved by the Research Ethics Committee of DEBBIOM (April 13, 2021). An informed consent form was signed by all volunteers before their participation in this study.