Search Results - "Kozeli, Devi"

Can non‐clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium by Park, Eunjung, Gintant, Gary A, Bi, Daoqin, Kozeli, Devi, Pettit, Syril D, Pierson, Jennifer B, Skinner, Matthew, Willard, James, Wisialowski, Todd, Koerner, John, Valentin, Jean‐Pierre

“…Background and Purpose Translation of non‐clinical markers of delayed ventricular repolarization to clinical prolongation of the QT interval corrected for…”
Get full text

Development of cardiac safety translational tools for QT prolongation and torsade de pointes by Valerio, Jr, Luis G, Balakrishnan, Suchitra, Fiszman, Monica L, Kozeli, Devi, Li, Mike, Moghaddam, Sarvin, Sadrieh, Nakissa

“…A regulatory science priority at the Food and Drug Administration (FDA) is to promote the development of new innovative tools such as reliable and validated…”
Get more information

The impact of drug-related QT prolongation on FDA regulatory decisions by Park, Eunjung, Willard, James, Bi, Daoqin, Fiszman, Monica, Kozeli, Devi, Koerner, John

Get full text

Can Nonclinical Repolarization Assays Predict the Results of Clinical Thorough QT Studies? A HESI-FDA Retrospective Analysis by Park, Eunjung, Gintant, Gary, Bi, Daoqin, Kozeli, Devi, Pettit, Syril, Pierson, Jennifer, Skinner, Matthew, Willard, James, Wisialowski, Todd, Koerner, John, Valentin, Jean-Pierre

Get full text

Predictivity of non-clinical repolarization assay data for clinical TQT data in FDA database by Valentin, Jean-Pierre, Koerner, John, Willard, James, Park, Eun Jung, Bi, Daoqin, Link, William, Fiszman, Monica, Kozeli, Devi, Skinner, Matt, Cantilena, Louis, Gintant, Gary, Wisialowski, Todd, Pettit, Syril, Vargas, Hugo

Get full text