Evidence map›Paper›PMID 30469350›Full record

ReviewInternational journal of molecular sciences2018

Biotherapeutics: Challenges and Opportunities for Predictive Toxicology of Monoclonal Antibodies.

Dale E Johnson

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in International journal of molecular sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

  1. Article
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  4. Review
  5. Article
  6. A versatile genomic transgenesis platform with enhancedFrontiers in bioengineering and biotechnology · 2023
    Article
  7. Article
  8. Review
  9. Article
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  11. Article
  12. Article
  13. Review
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  18. Review
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

1 author.

Dale E JohnsonMorgan Hall, University of California, Berkeley, Berkeley, CA 94720, USA. daleejohnson@berkeley.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biotherapeutics are a rapidly growing portion of the total pharmaceutical market accounting for almost one-half of recent new drug approvals. A major portion of these approvals each year are monoclonal antibodies (mAbs). During development, non-clinical pharmacology and toxicology testing of mAbs differs from that done with chemical entities since these biotherapeutics are derived from a biological source and therefore the animal models must share the same epitopes (targets) as humans to elicit a pharmacological response. Mechanisms of toxicity of mAbs are both pharmacological and non-pharmacological in nature; however, standard in silico predictive toxicological methods used in research and development of chemical entities currently do not apply to these biotherapeutics. Challenges and potential opportunities exist for new methodologies to provide a more predictive program to assess and monitor potential adverse drug reactions of mAbs for specific patients before and during clinical trials and after market approval.

Indexed as

AnimalsAntibodies, MonoclonalBiological TherapyDrug-Related Side Effects and Adverse ReactionsHumansAntibodies, Monoclonalacute phase reactionsanti-drug antibody (ADA)biomarkerscytokine releaseimmune complex assaysimmunogenicitymonoclonal antibodies (mAbs)

Identifiers

PMID30469350
PMCPMC6274697

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.