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Page 1
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C. Heimbach T, et al. Among authors: grimstein m. Mol Pharm. 2024 Nov 4;21(11):5353-5372. doi: 10.1021/acs.molpharmaceut.4c00758. Epub 2024 Sep 30. Mol Pharm. 2024. PMID: 39348508 Free PMC article. Review.
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation.
Pamuk GE, Chow ECY, Ionan AC, Chen H, Lee SL, Hsu V, Grimstein M, Zheng N, Sun J, Charlab R, Gehrke BJ, Vallejo J, Ehrlich LA, de Claro RA, Theoret MR. Pamuk GE, et al. Among authors: grimstein m. Clin Cancer Res. 2024 Oct 1;30(19):4266-4271. doi: 10.1158/1078-0432.CCR-24-1086. Clin Cancer Res. 2024. PMID: 39088257
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.
Barbato MI, Bradford D, Ren Y, Aungst SL, Miller CP, Pan L, Zirkelbach JF, Li Y, Bi Y, Fan J, Grimstein M, Dorff SE, Amatya AK, Mishra-Kalyani PS, Scepura B, Schotland P, Udoka O, Ojofeitimi I, Leighton JK, Rahman NA, Pazdur R, Singh H, Kluetz PG, Drezner N. Barbato MI, et al. Among authors: grimstein m. Clin Cancer Res. 2024 Aug 15;30(16):3364-3370. doi: 10.1158/1078-0432.CCR-24-0949. Clin Cancer Res. 2024. PMID: 38875108
US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.
Shah M, Lingam H, Gao X, Gittleman H, Fiero MH, Krol D, Biel N, Ricks TK, Fu W, Hamed S, Li F, Sun JJ, Fan J, Schuck R, Grimstein M, Tang L, Kalavar S, Abukhdeir A, Pathak A, Ghosh S, Bulatao I, Tilley A, Pierce WF, Mixter BD, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. Shah M, et al. Among authors: grimstein m. J Clin Oncol. 2024 Apr 1;42(10):1193-1201. doi: 10.1200/JCO.23.02112. Epub 2024 Feb 21. J Clin Oncol. 2024. PMID: 38381994 Clinical Trial.
FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.
Telaraja D, Kasamon YL, Collazo JS, Leong R, Wang K, Li P, Dahmane E, Yang Y, Earp J, Grimstein M, Rodriguez LR, Theoret MR, Gormley NJ. Telaraja D, et al. Among authors: grimstein m. Clin Cancer Res. 2024 Jan 5;30(1):17-22. doi: 10.1158/1078-0432.CCR-23-1272. Clin Cancer Res. 2024. PMID: 37624619 Free PMC article.
Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development.
Zhao S, Gockenbach M, Grimstein M, Sachs HC, Mirochnick M, Struble K, Belew Y, Wang J, Capparelli EV, Best BM, Johnson T, Momper JD, Maharaj AR. Zhao S, et al. Among authors: grimstein m. Front Pediatr. 2021 Oct 13;9:721059. doi: 10.3389/fped.2021.721059. eCollection 2021. Front Pediatr. 2021. PMID: 34722417 Free PMC article.
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