Evidence map›Paper›PMID 30051230›Full record

ArticleInternational journal of clinical pharmacy2018

Is pharmacovigilance of biologicals cost-effective?

Barbara Claus

Abstract read
PubMed Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2018. 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.

  1. Review
  2. Article
  3. Overview of this issue: pharmacovigilance, what is new?International journal of clinical pharmacy · 2018
    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

1 author.

Barbara ClausPharmacy Department, K12 Floor-1, C. Heymanslaan 10, 9000, Ghent, Belgium. Barbara.claus@uzgent.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacovigilance is an essential part of the post-marketing surveillance of new biologicals. It not only requires a substantial investment of the marketing authorization holder but also of the clinical field to provide accurate safety information. Hence, does pharmacovigilance delivers value for money? This important question needs to be discussed in the light of regulatory requirements, value and cost.

Indexed as

Health Care CostsPharmacovigilanceAdverse Drug Reaction Reporting SystemsBiological ProductsBiosimilar PharmaceuticalsCost-Benefit AnalysisDrug and Narcotic ControlDrug CostsDrug-Related Side Effects and Adverse ReactionsHumansPatient SafetyPolicy MakingRisk AssessmentRisk FactorsBiological ProductsBiosimilar PharmaceuticalsBiologicalsBiosimilarsCost-effectivenessPharmacovigilance

Identifiers

What OpenQuestion holds

Textmetadata
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.