Miller, Neil A. http://orcid.org/0000-0003-3077-5790
Graves, Rebecca H.
Edwards, Chris D.
Amour, Augustin
Taylor, Ed
Robb, Olivia
O’Brien, Brett
Patel, Aarti
Harrell, Andrew W.
Hessel, Edith M.
Article History
Accepted: 1 August 2021
First Online: 30 August 2021
Declarations
:
: No funding was received for the preparation of this article. GlaxoSmithKline paid the open access fee.
: Chris D. Edwards, Augustin Amour, Ed Taylor, Olivia Robb, Brett O’Brien, Aarti Patel and Andrew W. Harrell are employees of GlaxoSmithKline R&D and may hold stock or stock options. Neil A. Miller, Rebecca H. Graves & Edith M. Hessel were employees of GlaxoSmithKline R&D at the time this work was completed and may hold stock. Neil A. Miller and Rebecca H. Graves are now employees of Simulations Plus (UK) and may hold stock options and Edith M. Hessel is Chief Scientific Officer at Eligo Bioscience (Paris, France).
: The clinical studies adhered to the Declaration of Helsinki, were funded by GSK and were approved by the London Harrow Research Ethics Committee. All subjects gave their written informed consent prior to any study procedure. All animal studies were ethically reviewed and were carried out in accordance with the Animals (Scientific Procedures) Act 1986 and the GSK Policy on the Care, Welfare and Treatment of Animals.
: All subjects provided their informed consent for the present research as stated above.
: All authors provided their informed consent for publication.
: Data sharing was not applicable to this article as no clinical datasets were generated specifically for this manuscript. Input data are provided in the manuscript.
: The commercial PBPK platform GastroPlus® was used, as described in this manuscript.
: Writing, review and editing of the manuscript: NAM, RHG. Review and editing of the manuscript: CDE, AA, ET, OR, BO’B, AP, AWH, EMH. Modelling and simulation: NAM, RHG, ET. Research designed: EMH, CDE, OR, BO’B. Preclinical PK studies: OR, BO’B.