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Assessing drug-induced long QT and proarrhythmic risk using human stem cell-derived cardiomyocytes in a Ca2+ imaging assay: Evaluation of 28 CiPA compounds at three test sites

Toxicological Sciences, 2019

Hua Rong Lu, Haoyu Zeng, Ralf Kettenhofen, Liang Guo, Ivan Kopljar, Karel van Ammel, Fetene Tekle, Ard Teisman, Jin Zhai, Holly Clouse, Jennifer Pierson, Michael Furniss, Armando Lagrutta, Frederick Sannajust, David J Gallacher

A consortium, multi-site approach to testing in vitro assay technology for prediction of drug-induced TdP. The authors sought to test calcium transient assays using the CiPA 28 drugs.

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Improving Attribution of Adverse Events in Oncology Clinical Trials

Cancer Treatment Reviews, 2019

George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O’Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, a toxicity-attribution workshop was conducted in Silver Spring, MD to develop guidance for improving attribution of AEs in oncology clinical trials.

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Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

Drug Metabolism and Disposition, 2019

April Neal-Kluever, Jeffrey Fisher, Lawrence Grylack, Satoko Kakiuchi-Kiyota and Wendy Halpern

This review is part of a multisector collaborative research effort coordinated by the HESI Developmental and Reproductive Toxicology (DART) Committee to increase the knowledge base in the nonclinical neonatal space to better inform clinical treatment decisions made for the newborn patient population (De Schaepdrijver et al., 2018).

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