Evidence map›Paper›PMID 33389521›Full record

Trial reportJournal of pharmacokinetics and pharmacodynamics2021

Population pharmacokinetic modeling of intramuscular and oral dexamethasone and betamethasone in Indian women.

Wojciech Krzyzanski, Mark A Milad, Alan H Jobe, Thomas Peppard, Robert R Bies, William J Jusko

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pharmacokinetics and pharmacodynamics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 14% 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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Wojciech KrzyzanskiSchool of Pharmacy and Pharmaceutical Sciences, State University of New York, University of Buffalo, Buffalo, NY, USA.
Mark A MiladMilad Pharmaceutical Consulting LLC, Plymouth, MI, USA.
Alan H JobeDivision of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
Thomas PeppardCertara, Inc, Princeton, NJ, USA.
Robert R BiesSchool of Pharmacy and Pharmaceutical Sciences, State University of New York, University of Buffalo, Buffalo, NY, USA.
William J JuskoSchool of Pharmacy and Pharmaceutical Sciences, State University of New York, University of Buffalo, Buffalo, NY, USA. wjjusko@buffalo.edu.ORCID http://orcid.org/0000-0003-4027-0550
New York University · USCertara (United States) · USCincinnati Children's Hospital Medical Center · US

Funding

Mechanistic Pharmacokinetics and PharmacodynamicsR35GM131800 · NIGMS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI JUSKO, WILLIAM J. · 2019 to 2023
$2.9M
Bill and Melinda Gates Foundation INV-019894NIGMS NIH HHS GM131800NIGMS NIH HHS R35 GM131800
6 · The paper itself

Abstract

Population analysis of pharmacokinetic data for five differing dosage forms and routes for dexamethasone and betamethasone in 48 healthy nonpregnant Indian women was performed that accounted for a partial and complex cross-over design. Single doses of 6 mg dexamethasone phosphate (DEX-P), betamethasone phosphate (BET-P), or 1:1 mixture of betamethasone phosphate and acetate (BET-PA) were administered orally (PO) or intramuscularly (IM). Plasma concentrations collected for two periods over 96 h were described with a two-compartment model with differing PO and IM first-order absorption inputs. Clearances and volumes were divided by the IM bioavailability [Formula: see text]. The homogeneous ages, body weights, and ethnicity of the women obviated covariate analysis. Parameter estimates were obtained by the Laplace estimation method implemented in NONMEM 7.4. Typical values for dexamethasone were clearance ([Formula: see text] of 9.29 L/h, steady-state volume ([Formula: see text] of 56.4 L, IM absorption constant [Formula: see text] of 0.460 1/h and oral absorption constant ([Formula: see text] of 0.936 1/h. Betamethasone parameters were CL/F

Indexed as

Adrenal Cortex HormonesBetamethasoneDexamethasoneAdministration, OralAdultBiological AvailabilityBiological Variation, PopulationCross-Over StudiesDrug SubstitutionFemaleHalf-LifeHealthy VolunteersHumansIndiaInjections, IntramuscularYoung AdultAdrenal Cortex HormonesBetamethasoneDexamethasoneBetamethasoneDexamethasonePharmacokineticsPopulation modeling

Identifiers

PMID33389521
PMCPMC7778726
OpenAlexW3119083532

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.