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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.
Alvarez Baron, Claudia; Thiebaud, Nicolas; Ren, Ming; Viatchenko-Karpinski, Serge; Indapurkar, Amruta; King, Tamara; Matta, Murali K; Ismaiel, Omnia A; Patel, Vikram; Mashaee, Manni; Vicente, Jose; Wu, Wendy W.
Afiliação
  • 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.
  • 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.
  • 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.
  • Viatchenko-Karpinski 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; Cyprotex US, LLC, Watertown, MA, USA.
  • Indapurkar A; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; AbbVie Inc, North Chicago, IL, USA.
  • King T; Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA; Bristol-Myers Squibb, Princeton, NJ, 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.
  • 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.
  • 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; Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Cente
  • 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.
  • 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. Electronic address: wendy.wu@fda.hhs.gov.
J Pharmacol Toxicol Methods ; 117: 107193, 2022.
Article em En | MEDLINE | ID: mdl-35792285
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sotalol / Canais de Potássio Éter-A-Go-Go Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: J Pharmacol Toxicol Methods Assunto da revista: FARMACOLOGIA / TOXICOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sotalol / Canais de Potássio Éter-A-Go-Go Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: J Pharmacol Toxicol Methods Assunto da revista: FARMACOLOGIA / TOXICOLOGIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos