A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

por Madabushi, Rajanikanth, Wang, Yaning, Zineh, Issam
Publicado 2019

Emerging Role of Organ‐on‐a‐Chip Technologies in Quantitative Clinical Pharmacology Evaluation

por Isoherranen, Nina, Madabushi, Rajanikanth, Huang, Shiew‐Mei
Publicado 2019

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

por Madabushi, Rajanikanth, Seo, Paul, Zhao, Liang, Tegenge, Million, Zhu, Hao
Publicado 2022

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

por Hsieh, Julie, Sahre, Martina, Yang, Xinning, Madabushi, Rajanikanth, Ramamoorthy, Anuradha
Publicado 2022

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs

por Schuck, Robert N., Pacanowski, Michael, Kim, Sarah, Madabushi, Rajanikanth, Zineh, Issam
Publicado 2019

Need for Representation of Pediatric Patients with Obesity in Clinical Trials

por Samuels, Sherbet, Vaidyanathan, Jayabharathi, Fletcher, Elimika Pfuma, Ramamoorthy, Anuradha, Madabushi, Rajanikanth, Burckart, Gilbert J.
Publicado 2023

Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020

por Abulwerdi, Gelareh A., Ramamoorthy, Anuradha, Bashaw, Edward, Burckart, Gilbert J., Madabushi, Rajanikanth, Fletcher, Elimika Pfuma
Publicado 2023

Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives

por Marshall, Scott, Madabushi, Rajanikanth, Manolis, Efthymios, Krudys, Kevin, Staab, Alexander, Dykstra, Kevin, Visser, Sandra A.G.
Publicado 2019

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

por Bai, Jane P. F., Earp, Justin C., Florian, Jeffry, Madabushi, Rajanikanth, Strauss, David G., Wang, Yaning, Zhu, Hao
Publicado 2021

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

por Jean, Daphney, Naik, Kunal, Milligan, Lauren, Hall, Stephen, Mei Huang, Shiew, Isoherranen, Nina, Kuemmel, Colleen, Seo, Paul, Tegenge, Million A., Wang, Yaning, Yang, Yuching, Zhang, Xinyuan, Zhao, Liang, Zhao, Ping, Benjamin, Jessica, Bergman, Kimberly, Grillo, Joseph, Madabushi, Rajanikanth, Wu, Fang, Zhu, Hao, Zineh, Issam
Publicado 2021