Evidence map›Paper›PMID 42821031›Full record

ReviewDrug safety2026

Drug Brand Switching: A Regulatory Perspective.

Ping Siu Kee, Paul K L Chin, Michael Tatley, Rhiannon Braund, Martin A Kennedy, Simran D S Maggo

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Ping Siu KeeDepartment of Pathology and Molecular Medicine, University of Otago, Christchurch, New Zealand. pingsiu.kee@gmail.com.ORCID http://orcid.org/0000-0003-2194-6543
Paul K L ChinDepartment of Medicine, University of Otago, Christchurch, New Zealand.ORCID http://orcid.org/0000-0002-5470-5191
Michael TatleyCentre for Adverse Reactions Monitoring, New Zealand Pharmacovigilance Centre, University of Otago, Dunedin, New Zealand.ORCID http://orcid.org/0000-0003-3121-248X
Rhiannon BraundSchool of Pharmacy and Pharmaceutical Sciences, The University of Queensland, Brisbane, Australia.ORCID http://orcid.org/0000-0001-6574-1246
Martin A KennedyDepartment of Pathology and Molecular Medicine, University of Otago, Christchurch, New Zealand.ORCID http://orcid.org/0000-0002-6445-8526
Simran D S MaggoDepartment of Pharmacy, Biopharmaceutical Sciences and Pharmacogenomics, Shenandoah University, Winchester, VA, USA.ORCID http://orcid.org/0000-0002-7779-5206

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The replacement of expensive medications marketed by companies that bore the cost of development and testing, by low-cost "generics" once patent protection ends, is a common step in the life cycle of most drugs. Although generics are required to meet strict bioequivalence standards, the introduction of first-time and subsequent generics may lead to unease and increased reports of adverse effects or therapeutic failure. An established causal relationship between these effects and the switch from innovator to generic products can be challenging to assess. With the ongoing debate, this paper primarily explores how the regulatory framework governing generic drug approval may have contributed to this medical conundrum. In addition, we also offer a perspective on the potential role of pharmacogenetics within this setting.

Identifiers

What OpenQuestion holds

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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.