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Record W3203265145 · doi:10.1007/s40262-021-01072-4

Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling

2021· article· en· W3203265145 on OpenAlexaff
Jacqueline G. Gerhart, Fernando Carreño, Andrea N. Edginton, Jaydeep Sinha, Eliana M. Perrin, Karan R. Kumar, Aruna Rikhi, Christoph P. Hornik, Vincent Dormer Harris, Samit Ganguly, Michael Cohen‐Wolkowiez, Daniel González, Daniel K. Benjamin, Kanecia O. Zimmerman, Phyllis Kennel, Rose Beci, Chi D. Hornik, Gregory L. Kearns, Matthew M. Laughon, Ian M. Paul, Kelly C. Wade, Eunice Kennedy, Perdita Taylor‐Zapata, June Sung Lee, Ravinder Anand, Gaurav Sharma, Gina Simone, Kim Kaneshige, Lawrence Taylor, Ann Thomas Green, Robert H. Lurie

Bibliographic record

VenueClinical Pharmacokinetics · 2021
Typearticle
Languageen
FieldMedicine
TopicAntibiotics Pharmacokinetics and Efficacy
Canadian institutionsUniversity of Waterloo
FundersNational Institute of Child Health and Human DevelopmentEunice Kennedy Shriver National Institute of Child Health and Human DevelopmentUniversity of North Carolina at Chapel HillDuke Clinical Research InstituteNational Institute of General Medical SciencesPenn State College of MedicineWichita Medical Research and Education FoundationTexas Christian UniversityAmerican Foundation for Pharmaceutical EducationPennsylvania State UniversityUniversity of LouisvilleHealth Science Center, University of North TexasUniversity of PennsylvaniaChildren's Hospital of Philadelphia
KeywordsPharmacokineticsPopulationDosingClindamycinMedicineObesityVolume of distributionTrimethoprimPharmacologySulfamethoxazoleInternal medicineAntibioticsChemistryEnvironmental health

Abstract

fetched live from OpenAlex

BACKGROUND AND OBJECTIVE: While one in five children in the USA are now obese, and more than three-quarters receive at least one drug during childhood, there is limited dosing guidance for this vulnerable patient population. Physiologically based pharmacokinetic modeling can bridge the gap in the understanding of how pharmacokinetics, including drug distribution and clearance, changes with obesity by incorporating known obesity-related physiological changes in children. The objective of this study was to develop a virtual population of children with obesity to enable physiologically based pharmacokinetic modeling, then use the novel virtual population in conjunction with previously developed models of clindamycin and trimethoprim/sulfamethoxazole to better understand dosing of these drugs in children with obesity. METHODS: To enable physiologically based pharmacokinetic modeling, a virtual population of children with obesity was developed using national survey, electronic health record, and clinical trial data, as well as data extracted from the literature. The virtual population accounts for key obesity-related changes in physiology relevant to pharmacokinetics, including increased body size, body composition, organ size and blood flow, plasma protein concentrations, and glomerular filtration rate. The virtual population was then used to predict the pharmacokinetics of clindamycin and trimethoprim/sulfamethoxazole in children with obesity using previously developed physiologically based pharmacokinetic models. RESULTS: Model simulations predicted observed concentrations well, with an overall average fold error of 1.09, 1.24, and 1.53 for clindamycin, trimethoprim, and sulfamethoxazole, respectively. Relative to children without obesity, children with obesity experienced decreased clindamycin and trimethoprim/sulfamethoxazole weight-normalized clearance and volume of distribution, and higher absolute doses under recommended pediatric weight-based dosing regimens. CONCLUSIONS: Model simulations support current recommended weight-based dosing in children with obesity for clindamycin and trimethoprim/sulfamethoxazole, as they met target exposure despite these changes in clearance and volume of distribution.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Simulation or modeling · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.477
Threshold uncertainty score0.704

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.125
GPT teacher head0.420
Teacher spread0.295 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designSimulation or modeling
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations39
Published2021
Admission routes1
Has abstractyes

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