Evidence map›Paper›PMID 31628783›Full record

Trial reportClinical pharmacology in drug development2020

Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single-Blind, Single-Dose, Parallel-Group Study in Healthy Subjects.

Vincent Chow, MyungShin Oh, Melissa A Gessner, Gary Fanjiang

Abstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

4 authors.

Vincent ChowClinical Pharmacology, Amgen Inc., Thousand Oaks, California, USA.
MyungShin OhBiostatistics, Amgen Inc., Thousand Oaks, California, USA.
Melissa A GessnerClinical Immunology, Amgen Inc., Thousand Oaks, California, USA.
Gary FanjiangBiosimilars, Amgen Inc., Thousand Oaks, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This was a randomized, single-blind, single-dose, 3-arm parallel-group study. Healthy subjects were randomized to receive ABP 710 (n = 50) or infliximab reference product (RP) sourced from the United States (infliximab US; n = 50) or the European Union (infliximab EU; n = 50) 5 mg/kg intravenously over 2 hours. The primary endpoint was area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC

Indexed as

Administration, IntravenousAdultAntibodies, MonoclonalAntirheumatic AgentsArea Under CurveAustraliaBiosimilar PharmaceuticalsEuropean UnionFemaleHealthy VolunteersHumansInfliximabMaleMiddle AgedSafetySingle-Blind MethodAntibodies, MonoclonalAntirheumatic AgentsBiosimilar PharmaceuticalsInfliximabTumor Necrosis Factor InhibitorsABP 710biosimilarinfliximabmAbpharmacokinetics

Identifiers

PMID31628783
PMCPMC7027815

What OpenQuestion holds

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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.