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14 results

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Page 1
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: kothekar m. 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.
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: kothekar ma. 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.
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: kothekar m. JAMA. 2017 Jan 3;317(1):37-47. doi: 10.1001/jama.2016.18305. JAMA. 2017. PMID: 27918780 Clinical Trial.
A phase I pharmacokinetic and safety study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) alone and in combination with carboplatin in patients with advanced solid malignancies and biliary tract cancers.
Ma WW, Zhu M, Lam ET, Diamond JR, Dy GK, Fisher GA, Goff LW, Alberts S, Bui LA, Sanghal A, Kothekar M, Khopade A, Chimote G, Faulkner R, Eckhardt SG, Adjei AA, Jimeno A. Ma WW, et al. Among authors: kothekar m. Cancer Chemother Pharmacol. 2021 Jun;87(6):779-788. doi: 10.1007/s00280-021-04235-z. Epub 2021 Feb 26. Cancer Chemother Pharmacol. 2021. PMID: 33634324 Clinical Trial.
Intravenous pegylated liposomal prednisolone outperforms intramuscular methylprednisolone in treating rheumatoid arthritis flares: A randomized controlled clinical trial.
Metselaar JM, Middelink LM, Wortel CH, Bos R, van Laar JM, Vonkeman HE, Westhovens R, Lammers T, Yao SL, Kothekar M, Raut A, Bijlsma JWJ. Metselaar JM, et al. Among authors: kothekar m. J Control Release. 2022 Jan;341:548-554. doi: 10.1016/j.jconrel.2021.12.007. Epub 2021 Dec 10. J Control Release. 2022. PMID: 34896445 Clinical Trial.
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