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Page 1
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: prentice kw. 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.
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. 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.
Comprehensive Laboratory Evaluation of a Specific Lateral Flow Assay for the Presumptive Identification of Francisella tularensis in Suspicious White Powders and Aerosol Samples.
Pillai SP, DePalma L, Prentice KW, Ramage JG, Chapman C, Sarwar J, Parameswaran N, Petersen J, Yockey B, Young J, Singh A, Pillai CA, Manickam G, Thirunavkkarasu N, Avila JR, Sharma S, Morse SA, Venkateswaran K, Anderson K, Hodge DR. Pillai SP, et al. Among authors: prentice kw. Health Secur. 2020 Mar/Apr;18(2):83-95. doi: 10.1089/hs.2019.0151. Health Secur. 2020. PMID: 32324068 Free PMC article.
Comprehensive Laboratory Evaluation of a Lateral Flow Assay for the Detection of Yersinia pestis.
Prentice KW, DePalma L, Ramage JG, Sarwar J, Parameswaran N, Petersen J, Yockey B, Young J, Joshi M, Thirunavvukarasu N, Singh A, Chapman C, Avila JR, Pillai CA, Manickam G, Sharma SK, Morse SA, Venkateswaran KV, Anderson K, Hodge DR, Pillai SP. Prentice KW, et al. Health Secur. 2019 Nov/Dec;17(6):439-453. doi: 10.1089/hs.2019.0094. Health Secur. 2019. PMID: 31859568 Free PMC article.
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: prentice kw. 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.
Rapid Presumptive Identification of Bacillus anthracis Isolates Using the Tetracore RedLine Alert™ Test.
Pillai SP, Prentice KW, Ramage JG, DePalma L, Sarwar J, Parameswaran N, Bell M, Plummer A, Santos A, Singh A, Pillai CA, Thirunavvukarasu N, Manickam G, Avila JR, Sharma SK, Hoffmaster A, Anderson K, Morse SA, Venkateswaran KV, Hodge DR. Pillai SP, et al. Among authors: prentice kw. Health Secur. 2019 Jul/Aug;17(4):334-343. doi: 10.1089/hs.2019.0038. Health Secur. 2019. PMID: 31433282 Free PMC article.
Comprehensive Laboratory Evaluation of a Highly Specific Lateral Flow Assay for the Presumptive Identification of Bacillus anthracis Spores in Suspicious White Powders and Environmental Samples.
Ramage JG, Prentice KW, DePalma L, Venkateswaran KS, Chivukula S, Chapman C, Bell M, Datta S, Singh A, Hoffmaster A, Sarwar J, Parameswaran N, Joshi M, Thirunavkkarasu N, Krishnan V, Morse S, Avila JR, Sharma S, Estacio PL, Stanker L, Hodge DR, Pillai SP. Ramage JG, et al. Among authors: prentice kw. Health Secur. 2016 Sep-Oct;14(5):351-65. doi: 10.1089/hs.2016.0041. Health Secur. 2016. PMID: 27661796 Free PMC article.
Comprehensive laboratory evaluation of a specific lateral flow assay for the presumptive identification of abrin in suspicious white powders and environmental samples.
Ramage JG, Prentice KW, Morse SA, Carter AJ, Datta S, Drumgoole R, Gargis SR, Griffin-Thomas L, Hastings R, Masri HP, Reed MS, Sharma SK, Singh AK, Swaney E, Swanson T, Gauthier C, Toney D, Pohl J, Shakamuri P, Stuchlik O, Elder IA, Estacio PL, Garber EA, Hojvat S, Kellogg RB, Kovacs G, Stanker L, Weigel L, Hodge DR, Pillai SP. Ramage JG, et al. Among authors: prentice kw. Biosecur Bioterror. 2014 Jan-Feb;12(1):49-62. doi: 10.1089/bsp.2013.0080. Biosecur Bioterror. 2014. PMID: 24552362
11 results