ArticleScientific reports2025
Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices.
Abstract readComparative Study
In one paragraph
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.
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.
Who cites it
6 citing papers in PubMed.
- The Hidden Cost of QTc Assessment: A Quantitative Weight of Evidence Framework to Eliminate Structural False Positives and Restore the Lost Opportunity Cost of Abandoned Medicines.Clinical pharmacology and therapeutics · 2026Review
- Antiemetic Combination Use During the First Trimester and Adverse Circulatory Outcomes in Newborn Infants: A Data-Mining Analysis.Drug safety · 2026Article
- Establishment and Characterization of a Stable hERG Cell Line for High-Throughput Drug Cardiac Safety Screening.International journal of molecular sciences · 2026Article
- Organoids in drug development: from predictive models to regulatory integration.Drug discovery today · 2026Review
- Reassessing the Conduct of Patch Clamp Cardiac Ion Channel Assays to Improve Nonclinical Data Translation to Clinical ECG Changes and Proarrythmia Risk.Clinical and translational science · 2025Article
- Integrating drug effects on individual cardiac ionic currents and cardiac action potentials to understand nonclinical translation to clinical ECG changes.Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors.
Claudia Alvarez BaronDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jun ZhaoDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Huimei YuDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Ming RenDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Nicolas ThiebaudDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Donglin GuoDivision of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Giri VegesnaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Cheng-Hui HsiaoDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Ryan DePalmaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Sabyasachy MistryDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Isra TariqDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Md Shadiqur Rashid RoniDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Omnia A IsmaielDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Murali K MattaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Vikram PatelDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Manni MashaeeDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jose VicenteDivision of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Lars JohannesenDivision of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Jiansong ShengCiPA Lab, Gaithersburg, MD, USA.
Simon HebeisenB'SYS GmbH, Witterswil, Switzerland.
James KramerCharles River Laboratories, Cleveland, OH, USA.
Andrew Bruening-WrightCharles River Laboratories, Cleveland, OH, USA.
Koji NakanoDrug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan.
Hiroshi MatsukawaDrug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan.
Jennifer Beck PiersonHealth and Environmental Science Institute, Washington, DC, USA.
Wendy W WuDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. wendy.wu@fda.hhs.gov.
Funding
United States Food and Drug Administration Contract No. 75F40119C10150
Abstract
Acute block of hERG channels is the most common mechanism underlying drug-induced QT
Indexed as
ERG1 Potassium ChannelEther-A-Go-Go Potassium ChannelsPatch-Clamp TechniquesAnimalsDrug Evaluation, PreclinicalHumansLaboratoriesLong QT SyndromePotassium Channel BlockersReproducibility of ResultsERG1 Potassium ChannelEther-A-Go-Go Potassium ChannelsKCNH2 protein, humanPotassium Channel BlockersAssay reproducibilityCardiac safetyConcentration-inhibitionDelayed ventricular repolarizationExperimental uncertaintySafety margin
Identifiers
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LicenceCC BY
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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.