Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study by Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Mason, Jay, Sager, Philip, Patel, Vikram, Matta, Murali K., Li, Zhihua, Liu, Jiang, Garnett, Christine, Stockbridge, Norman, Zineh, Issam, Strauss, David G.

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Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial by Matta, Murali K, Zusterzeel, Robbert, Pilli, Nageswara R, Patel, Vikram, Volpe, Donna A, Florian, Jeffry, Oh, Luke, Bashaw, Edward, Zineh, Issam, Sanabria, Carlos, Kemp, Sarah, Godfrey, Anthony, Adah, Steven, Coelho, Sergio, Wang, Jian, Furlong, Lesley-Anne, Ganley, Charles, Michele, Theresa, Strauss, David G

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Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial by Matta, Murali K, Florian, Jeffry, Zusterzeel, Robbert, Pilli, Nageswara R, Patel, Vikram, Volpe, Donna A, Yang, Yang, Oh, Luke, Bashaw, Edward, Zineh, Issam, Sanabria, Carlos, Kemp, Sarah, Godfrey, Anthony, Adah, Steven, Coelho, Sergio, Wang, Jian, Furlong, Lesley-Anne, Ganley, Charles, Michele, Theresa, Strauss, David G

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A Bioanalytical Method for Quantification of N-nitrosodimethylamine (NDMA) in Human Plasma and Urine with Different Meals and following Administration of Ranitidine by De Palma, Ryan, Patel, Vikram, Florian, Jeffry, Keire, David, Selaya, Daniela, Strauss, David G., Rouse, Rodney, Matta, Murali K.

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Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study by Vicente, Jose, Zusterzeel, Robbert, Johannesen, Lars, Ochoa‐Jimenez, Roberto, Mason, Jay W., Sanabria, Carlos, Kemp, Sarah, Sager, Philip T., Patel, Vikram, Matta, Murali K., Liu, Jiang, Florian, Jeffry, Garnett, Christine, Stockbridge, Norman, Strauss, David G.

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Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics by Hyland, Paula L., Chekka, Lakshmi Manasa S., Samarth, Deepti P., Rosenzweig, Barry A., Decker, Erica, Mohamed, Esraa G., Guo, Yan, Matta, Murali K., Sun, Qin, Wheeler, William, Sanabria, Carlos, Weaver, James L., Schrieber, Sarah J., Florian, Jeffry, Wang, Yow‐Ming, Strauss, David G.

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Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation by Rubiano, Andrés, Indapurkar, Amruta, Yokosawa, Ryosuke, Miedzik, Alina, Rosenzweig, Barry, Arefin, Ayesha, Moulin, Chloe M., Dame, Keri, Hartman, Neil, Volpe, Donna A., Matta, Murali K., Hughes, David J., Strauss, David G., Kostrzewski, Tomasz, Ribeiro, Alexandre J. S.

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Simultaneous UHPLC-MS/MS method of estradiol metabolites to support the evaluation of Phase-2 metabolic activity of induced pluripotent stem cell derived hepatocytes by Indapurkar, Amruta, Hartman, Neil, Patel, Vikram, Matta, Murali K.

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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial by Florian, Jeffry, Matta, Murali K, DePalma, Ryan, Gershuny, Victoria, Patel, Vikram, Hsiao, Cheng-Hui, Zusterzeel, Robbert, Rouse, Rodney, Prentice, Kristin, Nalepinski, Colleen Gosa, Kim, Insook, Yi, Sojeong, Zhao, Liang, Yoon, Miyoung, Selaya, Susan, Keire, David, Korvick, Joyce, Strauss, David G

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Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen cl... by Pilli, Nageswara R., Narayanasamy, Suresh, Florian, Jeffry, Zusterzeel, Robbert, Patel, Vikram, Strauss, David G., Matta, Murali K.

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Quantitative analysis of underivatized 17 β-estradiol using a high-throughput LC–MS/MS assay – Application to support a pharmacokinetic study in ovariectomized guinea pigs by Gandhi, Adarsh, Matta, Murali K., Stewart, Sharron, Chockalingam, Ashok, Knapton, Alan, Rouse, Rodney, Wu, Wendy, Patel, Vikram

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Changes in drug crystallinity in a commercial tacrolimus amorphous formulation result in variable pharmacokinetics by Taylor, Lynne S., Trasi, Niraj S., Purohit, Hitesh S., Sun, Dajun, Kinjo, Minori, Ni, Zhanglin, Mahjabeen, Sanjida, Feng, Kairui (Kevin), Sun, Wei-Jhe, Matta, Murali K., Decker, Brian, Galinsky, Raymond E.

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists by Gershuny, Victoria, Sun, Qin, Schrieber, Sarah J., Matta, Murali K., Weaver, James L., Ji, Ping, Sheikhy, Morasa, Hsiao, Cheng‐Hui, Vegesna, Giri, Shah, Aanchal, Prentice, Kristin, Deering, Jennifer, Wang, Yow‐Ming, Strauss, David G., Florian, Jeffry

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors by Sheikhy, Morasa, Schrieber, Sarah J., Sun, Qin, Gershuny, Victoria, Matta, Murali K., Bai, Jane P.F., Du, Xiulian, Vegesna, Giri, Shah, Aanchal, Prentice, Kristin, Nalepinski, Colleen, Zineh, Issam, Wang, Yow‐Ming, Strauss, David G., Florian, Jeffry

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (III) A Randomized Trial with Interferon Beta‐1a Products by Florian, Jeffry, Gershuny, Victoria, Sun, Qin, Schrieber, Sarah J., Matta, Murali K., Hazel, Anthony, Sheikhy, Morasa, Weaver, James L., Hyland, Paula L., Hsiao, Cheng‐Hui, Vegesna, Giri, DePalma, Ryan, Shah, Aanchal, Prentice, Kristin, Sanabria, Carlos, Wang, Yow‐Ming, Strauss, David G.

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Novel and rapid LC-MS/MS method for quantitative analysis of methylphenidate in dried blood spots by Gandhi, Adarsh, Beekman, Christopher, Parker, Robert, Fang, Lanyan, Babiskin, Andrew, Matta, Murali K

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies by Li, Junyi, Florian, Jeffry, Campbell, Elizabeth, Schrieber, Sarah J., Bai, Jane P.F., Weaver, James L., Hyland, Paula L., Thway, Theingi M., Matta, Murali K., Lankapalli, Rachana H., Narayanasamy, Suresh, Dancy, Jimena, Zusterzeel, Robbert, Tyson, Jessica Y., Prentice, Kristin W., Jackson, Kathryn C., Patel, Vikram, Rouse, Rodney L., Wang, Yow‐Ming C., Strauss, David G.

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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 by 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.

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Novel High-Throughput Quantitation of Potent hERG Blocker Dofetilide in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry: Application in a Phase 1 ECG Biomarker Valid... by Matta, Murali K, Narayanasamy, Suresh, Vicente, Jose, Zusterzeel, Robbert, Patel, Vikram, Strauss, David G

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New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science by Chiu, Kimberly, Racz, Rebecca, Burkhart, Keith, Florian, Jeffry, Ford, Kevin, Iveth Garcia, M, Geiger, Robert M, Howard, Kristina E, Hyland, Paula L, Ismaiel, Omnia A, Kruhlak, Naomi L, Li, Zhihua, Matta, Murali K, Prentice, Kristin W, Shah, Aanchal, Stavitskaya, Lidiya, Volpe, Donna A, Weaver, James L, Wu, Wendy W, Rouse, Rodney, Strauss, David G

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