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Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

Clinical pharmacology and therapeutics, 2021-02, Vol.109 (2), p.319-333

2021

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Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative

Clinical pharmacology and therapeutics, 2019-02, Vol.105 (2), p.466-475

2019

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Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

Frontiers in physiology, 2017-08, Vol.8, p.616-616

2017

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Mechanisms of QT prolongation by buprenorphine cannot be explained by direct hERG channel block

PloS one, 2020-11, Vol.15 (11), p.e0241362-e0241362

2020

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Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment

Frontiers in physiology, 2017-11, Vol.8, p.917-917

2017

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Experimental factors that impact CaV1.2 channel pharmacology-Effects of recording temperature, charge carrier, and quantification of drug effects on the step and ramp currents elicited by the "step-step-ramp" voltage protocol

PloS one, 2022, Vol.17 (11), p.e0276995-e0276995

2022

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Ovarian hormone deficiency reduces intrinsic excitability and abolishes acute estrogen sensitivity in hippocampal CA1 pyramidal neurons

The Journal of neuroscience, 2011-02, Vol.31 (7), p.2638-2648

2011

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New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science

Frontiers in medicine, 2023-01, Vol.9, p.1109541-1109541

2023

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Functional changes in hippocampal synaptic signaling in offspring survivors of a mouse model of intrauterine inflammation

Journal of neuroinflammation, 2017-09, Vol.14 (1), p.180-180, Article 180

2017

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Ovarian hormone loss impairs excitatory synaptic transmission at hippocampal CA3-CA1 synapses

The Journal of neuroscience, 2013-10, Vol.33 (41), p.16158-16169

2013

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Apamin Boosting of Synaptic Potentials in CaV2.3 R-Type Ca2+ Channel Null Mice

PloS one, 2015, Vol.10 (9), p.e0139332-e0139332

2015

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IK1 channels do not contribute to the slow afterhyperpolarization in pyramidal neurons

eLife, 2016-01, Vol.5, p.e11206-e11206

2016

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Developmental profile of SK2 channel expression and function in CA1 neurons

Hippocampus, 2012-06, Vol.22 (6), p.1467-1480

2012

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Watermaze Learning Enhances Excitability of CA1 Pyramidal Neurons

Journal of neurophysiology, 2003-10, Vol.90 (4), p.2171-2179

2003

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ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies

Clinical pharmacology and therapeutics, 2023-12, Vol.114 (6), p.1332-1341

2023

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Corrigendum: Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

Frontiers in physiology, 2017-12, Vol.8, p.1025-1025

2017

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ICH S7B In Vitro Assays Do Not Address Mechanisms of QT C Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QT C Studies

Clinical pharmacology and therapeutics, 2023-12, Vol.114 (6), p.1332-1341

2023

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Transient Hypoxemia Disrupts Anatomical and Functional Maturation of Preterm Fetal Ovine CA1 Pyramidal Neurons

The Journal of neuroscience, 2019-10, Vol.39 (40), p.7853-7871

2019

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

Toxicology and applied pharmacology, 2020-05, Vol.394 (C), p.114961, Article 114961

2020

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Drug potency on inhibiting late Na+ current is sensitive to gating modifier and current region where drug effects were measured

Journal of pharmacological and toxicological methods, 2019-11, Vol.100, p.106605-106605, Article 106605

2019

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hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&As best practices: Impact of recording temperature and drug loss

Journal of pharmacological and toxicological methods, 2022-09, Vol.117, p.107193-107193, Article 107193

2022

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Users' experiences and perceptions on using two wiki platforms for collaborative learning and knowledge management

Online information review, 2013-01, Vol.37 (2), p.304-325

2013

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Characterization of loperamide-mediated block of hERG channels at physiological temperature and its proarrhythmia propensity

Journal of pharmacological and toxicological methods, 2017-11, Vol.88 (Pt 2), p.109-122

2017

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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]

Toxicology and applied pharmacology, 2020-05, Vol.395, p.114983, Article 114983

2020

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Coupling of L-Type Ca2+ Channels to KV7/KCNQ Channels Creates a Novel, Activity-Dependent, Homeostatic Intrinsic Plasticity

Journal of neurophysiology, 2008-10, Vol.100 (4), p.1897-1908

2008

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Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)

Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative

Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

Mechanisms of QT prolongation by buprenorphine cannot be explained by direct hERG channel block

Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment

Experimental factors that impact CaV1.2 channel pharmacology-Effects of recording temperature, charge carrier, and quantification of drug effects on the step and ramp currents elicited by the "step-step-ramp" voltage protocol

Ovarian hormone deficiency reduces intrinsic excitability and abolishes acute estrogen sensitivity in hippocampal CA1 pyramidal neurons

New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science

Functional changes in hippocampal synaptic signaling in offspring survivors of a mouse model of intrauterine inflammation

Ovarian hormone loss impairs excitatory synaptic transmission at hippocampal CA3-CA1 synapses

Apamin Boosting of Synaptic Potentials in CaV2.3 R-Type Ca2+ Channel Null Mice

IK1 channels do not contribute to the slow afterhyperpolarization in pyramidal neurons

Developmental profile of SK2 channel expression and function in CA1 neurons

Watermaze Learning Enhances Excitability of CA1 Pyramidal Neurons

ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies

Corrigendum: Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

ICH S7B In Vitro Assays Do Not Address Mechanisms of QT C Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QT C Studies

Transient Hypoxemia Disrupts Anatomical and Functional Maturation of Preterm Fetal Ovine CA1 Pyramidal Neurons

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

Drug potency on inhibiting late Na+ current is sensitive to gating modifier and current region where drug effects were measured

hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&As best practices: Impact of recording temperature and drug loss

Users' experiences and perceptions on using two wiki platforms for collaborative learning and knowledge management

Characterization of loperamide-mediated block of hERG channels at physiological temperature and its proarrhythmia propensity

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]

Coupling of L-Type Ca2+ Channels to KV7/KCNQ Channels Creates a Novel, Activity-Dependent, Homeostatic Intrinsic Plasticity

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