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Authors
Owen, Joel S. https://orcid.org/0000-0003-2638-8878
Rackley, Russell J.
Hummel, Matthew A.
Roepcke, Stefan
Huang, Hannah
Liu, Mark
Idris, Tazeen A.
Murugesan, Sundara Moorthi Nainar
Marwah, Ashwani
Loganathan, Subramanian
Ranganna, Gopinath
Barve, Abhijit
Waller, Cornelius F.
Socinski, Mark A.
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Funding
Funding for this research was provided by:
Mylan
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Article History
Accepted: 10 September 2023
First Online: 4 October 2023
Declarations
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: All the authors confirm that they were part of this study and have played a significant role from conceptualization of the study to the article preparation. Authorship for this study is considered following the ICMJE and COPE guidelines of authorship. All the authors approved the final version of the article along with the author order as presented in the article. JO contributed to the study conceptualization, design of the study, data analysis, result interpretation, and article writing. SN contributed to the study conceptualization, design, recruitment of participants’, data collection, data analysis, result interpretation, and article writing. RR, MH, SR, HH, ML, TI, AM, SL, GR, AB, CW and MS contributed to design, data collection, data analysis, and result interpretation.
: This project is funded by Viatris GmbH.
: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
: Not applicable.
: JO, SR, HH are consultants from Simulation Plus Inc. for Viatris for Pharmacometric analyses. MS; Research/grant funding from Spectrum, Novartis, Lilly, Genentech, and AstraZeneca; speaker bureau for Genentech, AstraZeneca, Guardant, Bristol Myers Squibb, Novartis, and Bayer. CW: Member of advisory board of Viatris. RR, MH, ML, TI, GR, AB: Full time employees of Viatris and may hold stock of Viatris. AM, SL, SN: Full time employees of Biocon and may hold stock of Biocon
: All procedures in this study were in accordance with the 1964 Helsinki declaration and its amendments. The phase I study was approved by Stichting Beoordeling Ethiek Biomedisch Onderzoek on 06 March 2015. The phase III study were conducted at multiple centers and institutional ethics committee approvals were obtained from the respective study sites (See Supplementary Table S2) prior to the subjects recruitment.
: All patients provided written informed consent before study participation.
