Evidence map›Paper›PMID 36912012›Full record

ArticleJournal of diabetes science and technology2024

Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.

Barry Lorbetskie, Stewart Bigelow, Lisa Walrond, Agnes V Klein, Shih-Miin Loo, Nancy Green, Michael Rosu-Myles, Xu Zhang, Huixin Lu, Michel Girard and 1 more

Open access · hybridAbstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

11 authors at 1 institution in 1 country.

Barry LorbetskieBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Stewart BigelowBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Lisa WalrondBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Agnes V KleinBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Shih-Miin LooBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Nancy GreenBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Michael Rosu-MylesBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Xu ZhangBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Huixin LuBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.ORCID 0000-0003-1553-5529
Michel GirardBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Simon SauvéBiologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, ON, Canada.
Health Canada · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification.

methodsTo address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods.

resultsWe demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content.

conclusionsBecause insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

Indexed as

Hypoglycemic AgentsAnimalsCanadaChromatography, High Pressure LiquidHumansInsulinInsulin DetemirInsulin, Long-ActingRecombinant ProteinsReproducibility of ResultsSwineHypoglycemic AgentsInsulininsulin degludecInsulin DetemirInsulin, Long-ActingRecombinant Proteinsbioanalyticalbiotherapeuticsdrug productsHPLCinsulinpharmacopoeia

Identifiers

PMID36912012
PMCPMC11418431
OpenAlexW4324020926

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.