Evidence map›Paper›PMID 39113219›Full record

ArticleBritish journal of clinical pharmacology2024

Nedosiran population pharmacokinetic and pharmacodynamic modelling and simulation to guide clinical development and dose selection in patients with primary hyperoxaluria type 1.

Steven Zhang, Aniruddha Amrite, Beesan Tan, Kris Jamsen, Sudeep Pradhan, Steve Choy, Horacio Plotkin

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

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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

7 authors.

Steven ZhangDicerna Pharmaceuticals, Inc. a Novo Nordisk company, Lexington, Massachusetts, USA.
Aniruddha AmritePyxis Oncology, Boston, Massachusetts, USA.
Beesan TanBioNTech US Inc., Cambridge, Massachusetts, USA.
Kris JamsenParexel International, Brisbane, Queensland, USA.
Sudeep PradhanParexel International, Brisbane, Queensland, USA.
Steve ChoyBoehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
Horacio PlotkinDicerna Pharmaceuticals, Inc. a Novo Nordisk company, Lexington, Massachusetts, USA.

Funding

Novo Nordisk
6 · The paper itself

Abstract

aimTo characterize pharmacokinetic and pharmacodynamic profiles of nedosiran in patients with primary hyperoxaluria type 1 (PH1), identify influential covariates and confirm therapeutic doses.

methodsA population pharmacokinetic (PK)/pharmacodynamic (PD) (POP-PKPD) model was developed to characterize the concentration-time course of nedosiran and the corresponding effect on 24-h urinary oxalate (U

resultsAnalyses included PK data from 143 healthy participants and PH1/PH2 patients, and PD data from 46 PH1 patients. Nedosiran PK was described by a two-compartment model with dual n-transit absorption and parallel linear and nonlinear elimination. The relationship between nedosiran exposure and U

conclusionsThe final POP-PKPD model characterizes observed nedosiran PK and U

Indexed as

Computer SimulationGlomerular Filtration RateHyperoxaluria, PrimaryModels, BiologicalAdolescentAdultBody WeightChildDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedOxalatesYoung AdultOxalatesmodellingnedosiranpharmacodynamicpharmacokineticprimary hyperoxaluria

Identifiers

PMID39113219
PMCPMC11602945

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.