Evidence map›Paper›PMID 38690782›Full record

ArticleCPT: pharmacometrics & systems pharmacology2024

Development of a physiologically based pharmacokinetic model of fostemsavir and its pivotal application to support dosing in pregnancy.

Farzaneh Salem, Dung Nguyen, Mark Bush, Katy P Moore, Jennypher Mudunuru, Konstantinos Stamatopoulos, Nilay Thakkar, Kunal S Taskar

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Farzaneh SalemDrug Metabolism and Pharmacokinetics, GlaxoSmithKline, R&D, Stevenage, UK.ORCID 0000-0003-1791-9390
Dung NguyenDrug Metabolism and Pharmacokinetics, GlaxoSmithKline R&D, Collegeville, Pennsylvania, USA.
Mark BushClinical Pharmacology, ViiV Research & Development, Triangle Park, North Carolina, USA.
Katy P MooreClinical Pharmacology Modeling and Simulation, Allucent, Cary, North Carolina, USA.
Jennypher MudunuruDrug Metabolism and Pharmacokinetics, GlaxoSmithKline, R&D, Stevenage, UK.ORCID 0009-0003-3132-7348
Konstantinos StamatopoulosBiopharmaceutics, DPD, MDS, GlaxoSmithKline, David Jack Centre, Park Road, Ware, UK.ORCID 0000-0002-7524-2800
Nilay ThakkarClinical Pharmacology Modeling and Simulation, GlaxoSmithKline R&D, Collegeville, Pennsylvania, USA.ORCID 0000-0002-2846-5796
Kunal S TaskarDrug Metabolism and Pharmacokinetics, GlaxoSmithKline, R&D, Stevenage, UK.ORCID 0000-0001-9979-8267
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USSimulation Technologies (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

It is critical to understand the impact of significant physiological changes during pregnancy on the extent of maternal and fetal drug exposure. Fostemsavir (FTR) is a prodrug of temsavir (TMR) and is approved in combination with other antiretrovirals for multi-drug-resistant human immunodeficiency virus (HIV) infections. This physiologically based pharmacokinetic model (PBPK) study was used to estimate TMR PK in pregnant populations during each trimester of pregnancy to inform FTR dosing. A PBPK model was developed and validated for TMR using PK data collected following intravenous TMR and oral FTR dosing (immediate-release and extended-release tablets) in healthy volunteers. Predicted TMR concentration-time profiles accurately predicted the reported clinical data and variability in healthy (dense data) and pregnant (sparse data) populations. Predicted versus observed TMR geometric mean (CV%) clearance following intravenous administration was 18.01 (29) versus 17 (21) (L/h). Predicted versus observed TMR AUC

Indexed as

Models, BiologicalMorpholinesOrganophosphatesAdministration, IntravenousAdministration, OralAdultArea Under CurveDelayed-Action PreparationsFemaleHealthy VolunteersHIV InfectionsHumansPiperazinesPregnancyYoung AdultDelayed-Action PreparationsfostemsavirMorpholinesOrganophosphatesPiperazines

Identifiers

PMID38690782
PMCPMC11578133
OpenAlexW4396555461

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.