Search Results - Kosalaram Goteti

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

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To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias by Sebastian Haertter, Jitendar Kanodia, Jack Cook, Jeanette Alicea, Bonnie J. Brennan, Amit Desai, Bela Patel, Lin Pan, Kosalaram Goteti

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Model‐based meta‐analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus by Kosalaram Goteti, Ramon Garcia, William R. Gillespie, Jonathan French, Lena Klopp‐Schulze, Ying Li, Cristina Vazquez Mateo, Sanjeev Roy, Oliver Guenther, Lisa Benincosa, Karthik Venkatakrishnan

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Phase 1 study in healthy participants of the safety, pharmacokinetics, and pharmacodynamics of enpatoran (M5049), a dual antagonist of toll‐like receptors 7 and 8 by Andreas Port, Jamie V. Shaw, Lena Klopp‐Schulze, Afrim Bytyqi, Claudia Vetter, Elizabeth Hussey, Nadra Mammasse, Victor Ona, Angelika Bachmann, Denis Strugala, Christian Reh, Kosalaram Goteti

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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 by Hong Lu, Lena Klopp‐Schulze, Jatinder Kaur Mukker, Dandan Li, Yoshihiro Kuroki, Jayaprakasam Bolleddula, Nadia Terranova, Kosalaram Goteti, Wei Gao, Rainer Strotmann, Jennifer Dong, Karthik Venkatakrishnan

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Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient‐level placebo (Standard‐of‐Care) data... by Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset‐Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan

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