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Multi-cardiac ion channel block profiles for lopinavir, ritonavir, chloroquine and vanoxerine align with clinical ECG changes and proarrhythmia: two case studies in support of the CiPA initiative.

(Download the Poster) https://www.fda.gov/media/169062/download

Claudia AlvarezBaron, FDA/CDER/OTS/OCP/DARS;

Jun Zhao, FDA/CDER/OTS/OCP/DARS;

Donglin Guo, FDA/CDER/OND/OCHEN/DCN;

Jose Vicente, FDA/CDER/OND/OCHEN/DCN;

Wendy W. Wu, FDA/CDER/OTS/OCP/DARS.

Determination of drugs with poor solubility in hERG external solution by LC-MS/MS to support hERG Potency Assessment

(Download the Poster) https://www.fda.gov/media/169035/download

Sabyasachy Mistry, FDA/CDER/OTS/OCP/DARS;

Jun Zhao, FDA/CDER/OTS/OCP/DARS;

Claudia Alvarez-Baron, FDA/CDER/OTS/OCP/DARS;

Wendy W. Wu, FDA/CDER/OTS/OCP/DARS;

Vikram Patel, FDA/CDER/OTS/OCP/DARS;

Rodney Rouse, FDA/CDER/OTS/OCP/DARS;

David Strauss, FDA/CDER/OTS/OCP/DARS;

Omnia Ismaiel, FDA/CDER/OTS/OCP/DARS..

A protocol to differentiate drug unbinding characteristics from cardiac sodium channel for proarrhythmia risk assessment

(Download the Poster) https://www.fda.gov/media/169048/download

Huimei Yu, FDA/CDER/OTS/OCP/DARS;

Claudia Alvarez-Baron, FDA/CDER/OTS/OCP/DARS;

Jun Zhao, FDA/CDER/OTS/OCP/DARS;

Wendy W. Wu, FDA/CDER/OTS/OCP/DARS;

Donglin Guo, FDA/CDER/OND/OCHEN/DCN

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

(Download the Manuscript) https://doi.org/10.1371/journal.pone.0276995

Ming Ren, Aaron L. Randolph, Claudia Alvarez-Baron, Donglin Guo, Phu N. Tran, Nicolas Thiebaud, Jiansong Sheng, Jun Zhao, Wendy W. Wu

ACA-24-3995.Highlighted: Determination of lopinavir and ritonavir in hERG solution to support in vitro hERG block potency assessment using LC-MS/MS: The challenge of poor drug solubility

(Download the Manuscript) https://doi.org/10.1016/j.aca.2025.343819

Sabyasachy Mistry, Jun Zhao, Claudia Alvarez-Baron, Wendy W. Wu, Omnia A. Ismaiel

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA