Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model‐Informed Precision Medicine von Terranova, Nadia, Venkatakrishnan, Karthik

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S7.3 - Enabling Asia-inclusive global drug development through quantitative and translational science von Venkatakrishnan, Karthik

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Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study von Rowland Yeo, Karen, Venkatakrishnan, Karthik

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Reverse Translation: The Art of Cyclical Learning von Kasichayanula, Sreeneeranj, Venkatakrishnan, Karthik

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Clinical Pharmacology of Ixazomib: The First Oral Proteasome Inhibitor von Gupta, Neeraj, Hanley, Michael J., Xia, Cindy, Labotka, Richard, Harvey, R. Donald, Venkatakrishnan, Karthik

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Population PK and Exposure–Response Relationships for the Antibody–Drug Conjugate Brentuximab Vedotin in CTCL Patients in the Phase III ALCANZA Study von Suri, Ajit, Mould, Diane R., Liu, Yi, Jang, Graham, Venkatakrishnan, Karthik

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Alternatives to rifampicin: A review and perspectives on the choice of strong CYP3A inducers for clinical drug–drug interaction studies von Bolleddula, Jayaprakasam, Gopalakrishnan, Sathej, Hu, Ping, Dong, Jennifer, Venkatakrishnan, Karthik

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How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model von Zheng, Songmao, Venkatakrishnan, Karthik, Kennedy, Beth Benatti

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Effect of severe renal impairment on the pharmacokinetics of brigatinib von Gupta, Neeraj, Hanley, Michael J., Kerstein, David, Tugnait, Meera, Narasimhan, Narayana, Marbury, Thomas C., Venkatakrishnan, Karthik

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Phase I study assessing the mass balance, pharmacokinetics, and excretion of [14C]-pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors von Zhou, Xiaofei, Sedarati, Farhad, Faller, Douglas V., Zhao, Dan, Faessel, Hélène M., Chowdhury, Swapan, Bolleddula, Jayaprakasam, Li, Yuexian, Venkatakrishnan, Karthik, Papai, Zsuzsanna

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Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations von DEES, E. Claire, COHEN, Roger B, MEHREN, Margaret Von, STINCHCOMBE, Thomas E, HUA LIU, VENKATAKRISHNAN, Karthik, MANFREDI, Mark, FINGERT, Howard, BURRIS, Howard A, INFANTE, Jeffrey R

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Switching from body surface area‐based to fixed dosing for the investigational proteasome inhibitor ixazomib: a population pharmacokinetic analysis von Gupta, Neeraj, Zhao, Yuan, Hui, Ai‐Min, Esseltine, Dixie‐Lee, Venkatakrishnan, Karthik

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Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development von Gao, Wei, Liu, Jiang, Shtylla, Blerta, Venkatakrishnan, Karthik, Yin, Donghua, Shah, Mirat, Nicholas, Timothy, Cao, Yanguang

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Explainable machine learning prediction of edema adverse events in patients treated with tepotinib von Amato, Federico, Strotmann, Rainer, Castello, Roberto, Bruns, Rolf, Ghori, Vishal, Johne, Andreas, Berghoff, Karin, Venkatakrishnan, Karthik, Terranova, Nadia

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Model‐informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets von Munafo, Alain, Terranova, Nadia, Li, Dandan, Liu, Ping, Venkatakrishnan, Karthik

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Variable or variate? A conundrum in pharmacometrics exposure–response models von Grisic, Ana‐Marija, Venkatakrishnan, Karthik, French, Jonathan, Khandelwal, Akash

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Phase I Study of the Investigational Aurora A Kinase Inhibitor Alisertib plus Rituximab or Rituximab/Vincristine in Relapsed/Refractory Aggressive B-cell Lymphoma von Kelly, Kevin R, Friedberg, Jonathan W, Park, Steven I, McDonagh, Kevin, Hayslip, John, Persky, Daniel, Ruan, Jia, Puvvada, Soham, Rosen, Peter, Iyer, Swaminathan Padmanabhan, Stefanovic, Alexandra, Bernstein, Steven H, Weitman, Steven, Karnad, Anand, Monohan, Gregory, VanderWalde, Ari, Mena, Raul, Schmelz, Monika, Spier, Catherine, Groshen, Susan, Venkatakrishnan, Karthik, Zhou, Xiaofei, Sheldon-Waniga, Emily, Leonard, E Jane, Mahadevan, Daruka

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Evaluation of the drug–drug interaction potential of brigatinib using a physiologically‐based pharmacokinetic modeling approach von Hanley, Michael J., Yeo, Karen Rowland, Tugnait, Meera, Iwasaki, Shinji, Narasimhan, Narayana, Zhang, Pingkuan, Venkatakrishnan, Karthik, Gupta, Neeraj

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Asia‐inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler von Lu, Hong, Klopp‐Schulze, Lena, Mukker, Jatinder Kaur, Li, Dandan, Kuroki, Yoshihiro, Bolleddula, Jayaprakasam, Terranova, Nadia, Goteti, Kosalaram, Gao, Wei, Strotmann, Rainer, Dong, Jennifer, Venkatakrishnan, Karthik

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Designing phase I oncology dose escalation using dose–exposure–toxicity models as a complementary approach to model‐based dose–toxicity models von Pantoja, Kristyn, Lanke, Shankar, Munafo, Alain, Victor, Anja, Habermehl, Christina, Schueler, Armin, Venkatakrishnan, Karthik, Girard, Pascal, Goteti, Kosalaram

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