Gerhart, Jacqueline G.
Carreño, Fernando O.
Edginton, Andrea N.
Sinha, Jaydeep
Perrin, Eliana M.
Kumar, Karan R.
Rikhi, Aruna
Hornik, Christoph P.
Harris, Vincent
Ganguly, Samit
Cohen-Wolkowiez, Michael
Gonzalez, Daniel http://orcid.org/0000-0001-5522-5686
Benjamin, Daniel K. Jr.
Hornik, Christoph
Zimmerman, Kanecia
Kennel, Phyllis
Beci, Rose
Hornik, Chi Dang
Kearns, Gregory L.
Laughon, Matthew
Paul, Ian M.
Sullivan, Janice
Wade, Kelly
Delmore, Paula
Kennedy, Eunice
Taylor-Zapata, Perdita
Lee, June
Anand, Ravinder
Sharma, Gaurav
Simone, Gina
Kaneshige, Kim
Taylor, Lawrence
Green, Ann Thomas
Lurie, Robert H.
,
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD096435, HHSN275201000003I)
American Foundation for Pharmaceutical Education
National Institute of General Medical Sciences (T32GM122741)
Article History
Accepted: 23 August 2021
First Online: 7 October 2021
Declarations
:
: This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under award R01HD096435. The PTN Data Repository was funded under NICHD contract HHSN275201000003I for the PTN (PI: Daniel K. Benjamin, Jr.). J.G.G. received research support from a National Institute of General Medical Sciences funded T32 program (T32GM122741) and through a Fred Eshelman Pre-Doctoral Fellowship in Pharmaceutical Sciences from the American Foundation for Pharmaceutical Education. D.G. received research support from the NICHD (R01HD096435). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
: M.C.-W. received support from the NICHD (HHSN275201000003I), the National Center for Advancing Translational Sciences [1U24TR001608]), and the FDA (1U18FD006298); he also receives research support from industry for neonatal and pediatric drug development,ExternalRef removed. The remaining authors have no relevant conflicts of interest to disclose.
: The original studies that facilitated the collection of the clindamycin and trimethoprim/sulfamethoxazole data were institutional review board approved. No new subject enrollment took place as part of this study. The PBPK modeling research was institutional review board approved at the University of North Carolina at Chapel Hill.
: Informed consent and assent, when applicable, were obtained from all participants enrolled in the original studies that facilitated the collection of the clindamycin and trimethoprim/sulfamethoxazole data who contributed clinical pharmacokinetic data used in this study.
: Not applicable.
: The open-source PBPK platform PK-Sim® was used, as described in this manuscript.
: Clindamycin and trimethoprim/sulfamethoxazole pharmacokinetic data collected by the Pediatric Trials Network were accessed through the NICHD Data and Specimen Hub (DASH,ExternalRef removed). To help expand the knowledge base for pediatric medicine, the PTN is pleased to share data from its completed and published studies with interested investigators. For requests, please contact: PTN-Program-Manager@dm.duke.edu.
: Participated in research design: J.G.G., A.N.E., and D.G. Performed the data analysis: J.G.G., F.O.C., J.S., S.G., and V.H. Wrote or contributed to the writing of the manuscript: J.G.G., F.O.C., A.N.E., J.S., E.M.P., K.R.K., A.R., C.P.H., V.H., S.G., M.C.W, and D.G.