Search Results - Rajanikanth Madabushi

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA by Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy

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Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration-Approved Drugs by Robert N. Schuck, Michael Pacanowski, Sarah Kim, Rajanikanth Madabushi, Issam Zineh

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Need for Representation of Pediatric Patients with Obesity in Clinical Trials by Sherbet Samuels, Jayabharathi Vaidyanathan, Elimika Pfuma Fletcher, Anuradha Ramamoorthy, Rajanikanth Madabushi, Gilbert J. Burckart

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Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020 by Gelareh A. Abulwerdi, Anuradha Ramamoorthy, Edward Bashaw, Gilbert J. Burckart, Rajanikanth Madabushi, Elimika Pfuma Fletcher

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Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration by Jane P. F. Bai, Justin C. Earp, Jeffry Florian, Rajanikanth Madabushi, David G. Strauss, Yaning Wang, Hao Zhu

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making-A workshop summary by Daphney Jean, Kunal Naik, Lauren Milligan, Stephen Hall, Shiew Mei Huang, Nina Isoherranen, Colleen Kuemmel, Paul Seo, Million A. Tegenge, Yaning Wang, Yuching Yang, Xinyuan Zhang, Liang Zhao, Ping Zhao, Jessica Benjamin, Kimberly Bergman, Joseph Grillo, Rajanikanth Madabushi, Fang Wu, Hao Zhu, Issam Zineh

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