Chand, Deepa H. http://orcid.org/0000-0002-0745-9338
Sun, Rui
Diab, Karim A. http://orcid.org/0000-0003-1690-7128
Kenny, Damien
Tukov, Francis Fonyuy http://orcid.org/0000-0002-0838-864X
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Received: 19 August 2022
Revised: 3 April 2023
Accepted: 12 April 2023
First Online: 25 April 2023
Competing interests
: Authors DC, RS, and FTT are employees and shareholders of Novartis Pharmaceuticals; and DK and KD received consulting fees for their expert contribution.
: Principles of the International Council of Harmonisation (ICH) M3 (R2) Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, ICH S6 (R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals and US Food and Drug Administration Guidance for Industry were applied. All clinical studies were performed in accordance with ethical principles in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice and applicable regulatory requirements. All clinical study protocols were approved by the institutional review boards or ethics committees, with appropriate informed consent obtained.