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A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab.
Waller CF, Vutikullird A, Lawrence TE, Shaw A, Liu MS, Baczkowski M, Sharma R, Barve A, Goyal P, Donnelly C, Sengupta N, Pennella EJ. Waller CF, et al. Among authors: barve a. Br J Clin Pharmacol. 2018 Oct;84(10):2336-2343. doi: 10.1111/bcp.13689. Epub 2018 Jul 31. Br J Clin Pharmacol. 2018. PMID: 29926514 Free PMC article. Clinical Trial.
Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial.
Rugo HS, Barve A, Waller CF, Hernandez-Bronchud M, Herson J, Yuan J, Sharma R, Baczkowski M, Kothekar M, Loganathan S, Manikhas A, Bondarenko I, Mukhametshina G, Nemsadze G, Parra JD, Abesamis-Tiambeng ML, Baramidze K, Akewanlop C, Vynnychenko I, Sriuranpong V, Mamillapalli G, Ray S, Yanez Ruiz EP, Pennella E; Heritage Study Investigators. Rugo HS, et al. Among authors: barve a. JAMA. 2017 Jan 3;317(1):37-47. doi: 10.1001/jama.2016.18305. JAMA. 2017. PMID: 27918780 Clinical Trial.
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ. Waller CF, et al. Among authors: barve a. J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18. J Cancer Res Clin Oncol. 2018. PMID: 29671069 Clinical Trial.
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Láng I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Waller CF, et al. Among authors: barve a. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1. Ann Hematol. 2019. PMID: 30824956 Free PMC article. Clinical Trial.
Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial.
Rugo HS, Pennella EJ, Gopalakrishnan U, Hernandez-Bronchud M, Herson J, Koch HF, Loganathan S, Deodhar S, Marwah A, Manikhas A, Bondarenko I, Parra JD, Abesamis-Tiambeng MLT, Akewanlop C, Vynnychenko I, Sriuranpong V, Roy S, Yanez Ruiz EP, Barve A, Waller CF. Rugo HS, et al. Among authors: barve a. Breast. 2021 Aug;58:18-26. doi: 10.1016/j.breast.2021.03.009. Epub 2021 Apr 1. Breast. 2021. PMID: 33892316 Free PMC article. Clinical Trial.
132 results