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Page 1
Model-Informed Selection of the Recommended Phase III Dose of the Inhibitor of Apoptosis Protein Inhibitor, Xevinapant, in Combination with Cisplatin and Concurrent Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Vugmeyster Y, Ravula A, Rouits E, Diderichsen PM, Kleijn HJ, Koenig A, Wang X, Schroeder A, Goteti K, Venkatakrishnan K. Vugmeyster Y, et al. Among authors: goteti k. Clin Pharmacol Ther. 2024 Jan;115(1):52-61. doi: 10.1002/cpt.3065. Epub 2023 Oct 23. Clin Pharmacol Ther. 2024. PMID: 37777832 Clinical Trial.
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 to enable model-informed drug development.
Goteti K, French J, Garcia R, Li Y, Casset-Semanaz F, Aydemir A, Townsend R, Mateo CV, Studham M, Guenther O, Kao A, Gastonguay M, Girard P, Benincosa L, Venkatakrishnan K. Goteti K, et al. CPT Pharmacometrics Syst Pharmacol. 2023 Feb;12(2):180-195. doi: 10.1002/psp4.12888. Epub 2022 Nov 29. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36350330 Free PMC article.
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: goteti k. Clin Pharmacol Ther. 2024 Jun;115(6):1346-1357. doi: 10.1002/cpt.3216. Epub 2024 Feb 28. Clin Pharmacol Ther. 2024. PMID: 38415785
Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper.
Sawant-Basak A, Urva S, Mukker JK, Haertter S, Mariano D, Parasrampuria DA, Goteti K, Singh RSP, Chiney M, Liao MZ, Chang SS, Mehta R. Sawant-Basak A, et al. Among authors: goteti k. Clin Pharmacol Ther. 2024 Oct;116(4):902-913. doi: 10.1002/cpt.3350. Epub 2024 Jul 7. Clin Pharmacol Ther. 2024. PMID: 38973127 Review.
Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial.
Wu YL, Guarneri V, Voon PJ, Lim BK, Yang JJ, Wislez M, Huang C, Liam CK, Mazieres J, Tho LM, Hayashi H, Nhung NV, Chia PL, de Marinis F, Raskin J, Zhou Q, Finocchiaro G, Le AT, Wang J, Dooms C, Kato T, Nadal E, Hin HS, Smit EF, Wermke M, Tan D, Morise M, O'Brate A, Adrian S, Pfeiffer BM, Stroh C, Juraeva D, Strotmann R, Goteti K, Berghoff K, Ellers-Lenz B, Karachaliou N, Le X, Kim TM; INSIGHT 2 investigators. Wu YL, et al. Among authors: goteti k. Lancet Oncol. 2024 Aug;25(8):989-1002. doi: 10.1016/S1470-2045(24)00270-5. Lancet Oncol. 2024. PMID: 39089305 Clinical Trial.
Safety, Tolerability, and Pharmacodynamics of the ADAMTS-5 Nanobody M6495: Two Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies in Healthy Subjects and Patients With Osteoarthritis.
Bihlet AR, Balchen T, Goteti K, Sonne J, Ladel C, Karsdal MA, Ona V, Moreau F, Waterhouse R, Bay-Jensen AC, Guehring H. Bihlet AR, et al. Among authors: goteti k. ACR Open Rheumatol. 2024 Apr;6(4):205-213. doi: 10.1002/acr2.11610. Epub 2024 Feb 4. ACR Open Rheumatol. 2024. PMID: 38311369 Free PMC article.
Tepotinib in a Patient With Advanced Non-Small Cell Lung Cancer Harboring MET Exon 14 Skipping Undergoing Concomitant Hemodialysis for Renal Failure: A Case Report.
Kleemiss M, Müller CE, Schneider M, Strotmann R, Orlowski K, Goteti K, Yanik M, Brossart P, Bauernfeind FG. Kleemiss M, et al. Among authors: goteti k. Clin Lung Cancer. 2024 Sep;25(6):577-580. doi: 10.1016/j.cllc.2024.05.008. Epub 2024 May 25. Clin Lung Cancer. 2024. PMID: 38987049 Free article. No abstract available.
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: goteti k. Clin Transl Sci. 2024 Oct;17(10):e70050. doi: 10.1111/cts.70050. Clin Transl Sci. 2024. PMID: 39445632 Free PMC article. Review.
32 results