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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.

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Title: Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices.
Authors: Alvarez Baron C; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Zhao J; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Yu H; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Division of Pharmacology/Toxicology Review, Office of Safety and Clinical Evaluation, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Ren M; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Thiebaud N; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Vertex Pharmaceuticals (Europe) Ltd, Abingdon, Oxfordshire, UK., Guo D; Division 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., Vegesna G; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Hsiao CH; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., DePalma R; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Mistry S; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Tariq I; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Roni MSR; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Ismaiel OA; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Division of Nonclinical Science, Office of Science, Center for Tobacco Products, US Food and Drug Administration, Silver Spring, MD, USA., Matta MK; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis, Merck & Co., Inc., West Point, PA, USA., Patel V; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Mashaee M; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Vicente J; Division 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.; Translational Cures, Washington, DC, USA., Johannesen L; Division 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., Sheng J; CiPA Lab, Gaithersburg, MD, USA., Hebeisen S; B'SYS GmbH, Witterswil, Switzerland., Kramer J; Charles River Laboratories, Cleveland, OH, USA., Bruening-Wright A; Charles River Laboratories, Cleveland, OH, USA., Nakano K; Drug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan., Matsukawa H; Drug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan., Pierson JB; Health and Environmental Science Institute, Washington, DC, USA., Wu WW; Division 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.
Source: Scientific reports [Sci Rep] 2025 Aug 16; Vol. 15 (1), pp. 29995. Date of Electronic Publication: 2025 Aug 16.
Publication Type: Journal Article; Comparative Study
Journal Info: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices.
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  Data: <searchLink fieldCode="AU" term="%22Alvarez+Baron+C%22">Alvarez Baron C</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Zhao+J%22">Zhao J</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Yu+H%22">Yu H</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Division of Pharmacology/Toxicology Review, Office of Safety and Clinical Evaluation, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Ren+M%22">Ren M</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Thiebaud+N%22">Thiebaud N</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Vertex Pharmaceuticals (Europe) Ltd, Abingdon, Oxfordshire, UK.<br /><searchLink fieldCode="AU" term="%22Guo+D%22">Guo D</searchLink>; Division 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.<br /><searchLink fieldCode="AU" term="%22Vegesna+G%22">Vegesna G</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Hsiao+CH%22">Hsiao CH</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22DePalma+R%22">DePalma R</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mistry+S%22">Mistry S</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Tariq+I%22">Tariq I</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Roni+MSR%22">Roni MSR</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Ismaiel+OA%22">Ismaiel OA</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Division of Nonclinical Science, Office of Science, Center for Tobacco Products, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Matta+MK%22">Matta MK</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis, Merck & Co., Inc., West Point, PA, USA.<br /><searchLink fieldCode="AU" term="%22Patel+V%22">Patel V</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mashaee+M%22">Mashaee M</searchLink>; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Vicente+J%22">Vicente J</searchLink>; Division 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.; Translational Cures, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Johannesen+L%22">Johannesen L</searchLink>; Division 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.<br /><searchLink fieldCode="AU" term="%22Sheng+J%22">Sheng J</searchLink>; CiPA Lab, Gaithersburg, MD, USA.<br /><searchLink fieldCode="AU" term="%22Hebeisen+S%22">Hebeisen S</searchLink>; B'SYS GmbH, Witterswil, Switzerland.<br /><searchLink fieldCode="AU" term="%22Kramer+J%22">Kramer J</searchLink>; Charles River Laboratories, Cleveland, OH, USA.<br /><searchLink fieldCode="AU" term="%22Bruening-Wright+A%22">Bruening-Wright A</searchLink>; Charles River Laboratories, Cleveland, OH, USA.<br /><searchLink fieldCode="AU" term="%22Nakano+K%22">Nakano K</searchLink>; Drug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan.<br /><searchLink fieldCode="AU" term="%22Matsukawa+H%22">Matsukawa H</searchLink>; Drug Safety Testing Center Co., Ltd., Higashimatsuyama Laboratories, Saitama, Japan.<br /><searchLink fieldCode="AU" term="%22Pierson+JB%22">Pierson JB</searchLink>; Health and Environmental Science Institute, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Wu+WW%22">Wu WW</searchLink>; Division 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.
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