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New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.
Chiu K, Racz R, Burkhart K, Florian J, Ford K, Iveth Garcia M, Geiger RM, Howard KE, Hyland PL, Ismaiel OA, Kruhlak NL, Li Z, Matta MK, Prentice KW, Shah A, Stavitskaya L, Volpe DA, Weaver JL, Wu WW, Rouse R, Strauss DG. Chiu K, et al. Among authors: hyland pl. Front Med (Lausanne). 2023 Jan 19;9:1109541. doi: 10.3389/fmed.2022.1109541. eCollection 2022. Front Med (Lausanne). 2023. PMID: 36743666 Free PMC article. Review.
Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.
Li J, Florian J, Campbell E, Schrieber SJ, Bai JPF, Weaver JL, Hyland PL, Thway TM, Matta MK, Lankapalli RH, Narayanasamy S, Dancy J, Zusterzeel R, Tyson JY, Prentice KW, Jackson KC, Patel V, Rouse RL, Wang YC, Strauss DG. Li J, et al. Among authors: hyland pl. Clin Pharmacol Ther. 2020 Jan;107(1):40-42. doi: 10.1002/cpt.1653. Epub 2019 Oct 31. Clin Pharmacol Ther. 2020. PMID: 31667825 Free PMC article. No abstract available.
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics.
Hyland PL, Chekka LMS, Samarth DP, Rosenzweig BA, Decker E, Mohamed EG, Guo Y, Matta MK, Sun Q, Wheeler W, Sanabria C, Weaver JL, Schrieber SJ, Florian J, Wang YM, Strauss DG. Hyland PL, et al. Clin Pharmacol Ther. 2023 Jan;113(1):98-107. doi: 10.1002/cpt.2778. Epub 2022 Nov 19. Clin Pharmacol Ther. 2023. PMID: 36308070 Clinical Trial.
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products.
Florian J, Gershuny V, Sun Q, Schrieber SJ, Matta MK, Hazel A, Sheikhy M, Weaver JL, Hyland PL, Hsiao CH, Vegesna G, DePalma R, Shah A, Prentice K, Sanabria C, Wang YM, Strauss DG. Florian J, et al. Among authors: hyland pl. Clin Pharmacol Ther. 2023 Feb;113(2):339-348. doi: 10.1002/cpt.2784. Epub 2022 Dec 2. Clin Pharmacol Ther. 2023. PMID: 36324229 Clinical Trial.
Genome-wide association study of café-au-lait macule number in neurofibromatosis type 1.
Sung H, Hyland PL, Pemov A, Sabourin JA, Baldwin AM, Bass S, Teshome K, Luo W; Frederick National Laboratory for Cancer Research; Widemann BC, Stewart DR, Wilson AF. Sung H, et al. Among authors: hyland pl. Mol Genet Genomic Med. 2020 Oct;8(10):e1400. doi: 10.1002/mgg3.1400. Epub 2020 Aug 31. Mol Genet Genomic Med. 2020. PMID: 32869517 Free PMC article.
Agnostic Pathway/Gene Set Analysis of Genome-Wide Association Data Identifies Associations for Pancreatic Cancer.
Walsh N, Zhang H, Hyland PL, Yang Q, Mocci E, Zhang M, Childs EJ, Collins I, Wang Z, Arslan AA, Beane-Freeman L, Bracci PM, Brennan P, Canzian F, Duell EJ, Gallinger S, Giles GG, Goggins M, Goodman GE, Goodman PJ, Hung RJ, Kooperberg C, Kurtz RC, Malats N, LeMarchand L, Neale RE, Olson SH, Scelo G, Shu XO, Van Den Eeden SK, Visvanathan K, White E, Zheng W; PanScan and PanC4 consortia; Albanes D, Andreotti G, Babic A, Bamlet WR, Berndt SI, Borgida A, Boutron-Ruault MC, Brais L, Brennan P, Bueno-de-Mesquita B, Buring J, Chaffee KG, Chanock S, Cleary S, Cotterchio M, Foretova L, Fuchs C, M Gaziano JM, Giovannucci E, Goggins M, Hackert T, Haiman C, Hartge P, Hasan M, Helzlsouer KJ, Herman J, Holcatova I, Holly EA, Hoover R, Hung RJ, Janout V, Klein EA, Kurtz RC, Laheru D, Lee IM, Lu L, Malats N, Mannisto S, Milne RL, Oberg AL, Orlow I, Patel AV, Peters U, Porta M, Real FX, Rothman N, Sesso HD, Severi G, Silverman D, Strobel O, Sund M, Thornquist MD, Tobias GS, Wactawski-Wende J, Wareham N, Weiderpass E, Wentzensen N, Wheeler W, Yu H, Zeleniuch-Jacquotte A, Kraft P, Li D, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA, Amundadottir LT, Yu K, Klein AP, Stolzenberg-Solomon RZ. Walsh N, et al. Among authors: hyland pl. J Natl Cancer Inst. 2019 Jun 1;111(6):557-567. doi: 10.1093/jnci/djy155. J Natl Cancer Inst. 2019. PMID: 30541042 Free PMC article.
Associations Between Prediagnostic Concentrations of Circulating Sex Steroid Hormones and Esophageal/Gastric Cardia Adenocarcinoma Among Men.
Petrick JL, Hyland PL, Caron P, Falk RT, Pfeiffer RM, Dawsey SM, Abnet CC, Taylor PR, Weinstein SJ, Albanes D, Freedman ND, Gapstur SM, Bradwin G, Guillemette C, Campbell PT, Cook MB. Petrick JL, et al. Among authors: hyland pl. J Natl Cancer Inst. 2019 Jan 1;111(1):34-41. doi: 10.1093/jnci/djy082. J Natl Cancer Inst. 2019. PMID: 29788475 Free PMC article.
54 results