James Kramer

Variability of manual patch clamp data on Ca 1.2 and Na 1.5 channels generated using standardized protocols and following ICH S7B Q&A 2.1 best practices – Progress update of a HESI-coordinated multi-laboratory study

Huimei Yu, Claudia Alvarez Baron, Jun Zhao, Ming Ren et autres

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Variability of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

Claudia P. Alvarez Baron, Jun Wei Zhao, Huimei Yu, Ming Ren et autres

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Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

Claudia Alvarez Baron, Jun Wei Zhao, Huimei Yu, Ming Ren et autres

risk assessment in late-stage clinical development. To interpret the hERG results, understanding hERG assay reproducibility or hERG data variability is pivotal. Protocol and best practice recommendations have been provided with the goal of minimizing lab-to-lab data differences, but the impact remains unclear. …

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Legacy hERG study data in contemporary integrated risk assessments – mitigating the risk of protocol and positive control article differences

R. Daniëls, James Kramer, Matthew M. Abernathy, Derek Best et autres

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Modeling the topographic lateral resolution of interferometers

Peter J. de Groot, James Kramer, Torrie P. Sutherland

Performance characteristics for interferometers that measure surface topography include the ability to resolve closely spaced surface features, referred to as topographic spatial resolution. Within well-defined limits, scalar diffraction theory and classical Fourier optics provide a software model for prediction of the resolution …

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Applying the CiPA approach to evaluate cardiac proarrhythmia risk of some antimalarials used off‐label in the first wave of COVID‐19

Annie G. Delaunois, Matthew M. Abernathy, Warren D. Anderson, Kylie A. Beattie et autres

Abstract We applied a set of in silico and in vitro assays, compliant with the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm, to assess the risk of chloroquine (CLQ) or hydroxychloroquine (OH‐CLQ)‐mediated QT prolongation and Torsades de Pointes (TdP), alone and combined …

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A new method to assess a unique mechanism of drug targeting sodium channels involved in pain

James Kramer, Caiyun Wu, Zhiqi Liu, Yuri A. Kuryshev

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Publisher Correction: Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells

James Kramer, Herbert M. Himmel, Anders Lindqvist, Sonja Stoelzle‐Feix et autres

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

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A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model

Xiaomei Han, Mohammadreza Samieegohar, Bradley J. Ridder, Wendy Wu et autres

INTRODUCTION: In response to the ongoing shift of the regulatory cardiac safety paradigm, a recent White Paper proposed general principles for developing and implementing proarrhythmia risk prediction models. These principles included development strategies to validate models, and implementation strategies to ensure a …

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Corrigendum to “A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm” [Toxicology and Applied Pharmacology volume 394C (2020) 114961]

Bradley J. Ridder, Derek J. Leishman, Matthew H. Bridgland-Taylor, Mohammadreza Samieegohar et autres

© 2020 The Author(s) The authors regret that one affiliation address is mistaken in the published paper. Matthew Bridgland-Taylor's affiliation was incorrectly listed as Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom. The correct affiliation is Clinical Pharmacology & Safety …

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Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells

James Kramer, Herbert M. Himmel, Anders Lindqvist, Sonja Stoelzle‐Feix et autres

Abstract Automated patch clamp (APC) instruments enable efficient evaluation of electrophysiologic effects of drugs on human cardiac currents in heterologous expression systems. Differences in experimental protocols, instruments, and dissimilar site procedures affect the variability of IC50 values characterizing drug block potency. This …

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A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm

Bradley J. Ridder, Derek J. Leishman, Matthew H. Bridgland-Taylor, Mohammadreza Samieegohar et autres

INTRODUCTION: hERG block potency is widely used to calculate a drug's safety margin against its torsadogenic potential. Previous studies are confounded by use of different patch clamp electrophysiology protocols and a lack of statistical quantification of experimental variability. Since the new cardiac …

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