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Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial.
Klopp-Schulze L, Gopalakrishnan S, Yalkinoglu Ö, Kuroki Y, Lu H, Goteti K, Krebs-Brown A, Nogueira Filho M, Gradhand U, Fluck M, Shaw J, Dong J, Venkatakrishnan K. Klopp-Schulze L, et al. Among authors: dong j. Clin Pharmacol Ther. 2024 Jun;115(6):1346-1357. doi: 10.1002/cpt.3216. Epub 2024 Feb 28. Clin Pharmacol Ther. 2024. PMID: 38415785
Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations.
Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Xiong W, et al. Among authors: dong j. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30. Cancer Chemother Pharmacol. 2022. PMID: 35771259 Free PMC article. Clinical Trial.
Asia-inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler.
Lu H, Klopp-Schulze L, Mukker JK, Li D, Kuroki Y, Bolleddula J, Terranova N, Goteti K, Gao W, Strotmann R, Dong J, Venkatakrishnan K. Lu H, et al. Among authors: dong j. Clin Transl Sci. 2024 Oct;17(10):e70050. doi: 10.1111/cts.70050. Clin Transl Sci. 2024. PMID: 39445632 Free PMC article. Review.
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