Evidence map›Paper›PMID 28618191›Full record

ArticleClinical and translational science2017

A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety.

E Dubcenco, P M Beers-Block, L P Kim, P Schotland, J G Levine, C A McCloskey, E D Bashaw

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05849883 (Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05849883 nacompletednot on this mapstarted 2020, after this paper: background citation

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

TypeinterventionalSponsorPT Kalbe Farma TbkRan2020 to 2021Enrolled36ConditionsDrug UseArmsOmeprazole 20 mg Capsules
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
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.

E DubcencoRobarts Clinical Trials Inc., University of Western Ontario, London, Ontario, Canada.
P M Beers-BlockRutgers, State University of New Jersey, The Biopharma Educational Initiative, Newark, New Jersey, USA.
L P KimRutgers, State University of New Jersey, The Biopharma Educational Initiative, Newark, New Jersey, USA.
P SchotlandOak Ridge Institute for Science and Education, Oak Ridge, Tennessee, USA.
J G LevineU.S. Food and Drug Administration, Silver Spring, Maryland, USA.
C A McCloskeyU.S. Food and Drug Administration, Silver Spring, Maryland, USA.
E D BashawU.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a "surrogate" for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug ApprovalFractures, BoneHumansProton Pump InhibitorsPublicationsTherapeutic EquivalencyTime FactorsProton Pump Inhibitors

Identifiers

PMID28618191
PMCPMC5593167

What OpenQuestion holds

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Registered trials

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.