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3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration.
Wang H, Brown PC, Chow ECY, Ewart L, Ferguson SS, Fitzpatrick S, Freedman BS, Guo GL, Hedrich W, Heyward S, Hickman J, Isoherranen N, Li AP, Liu Q, Mumenthaler SM, Polli J, Proctor WR, Ribeiro A, Wang JY, Wange RL, Huang SM. Wang H, et al. Among authors: brown pc. Clin Transl Sci. 2021 Sep;14(5):1659-1680. doi: 10.1111/cts.13066. Epub 2021 Jun 16. Clin Transl Sci. 2021. PMID: 33982436 Free PMC article. Review.
An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. Avila AM, et al. Among authors: brown pc. Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. Regul Toxicol Pharmacol. 2020. PMID: 32325112
Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate).
Baran SW, Brown PC, Baudy AR, Fitzpatrick SC, Frantz C, Fullerton A, Gan J, Hardwick RN, Hillgren KM, Kopec AK, Liras JL, Mendrick DL, Nagao R, Proctor WR, Ramsden D, Ribeiro AJS, Stresser D, Sung KE, Sura R, Tetsuka K, Tomlinson L, Van Vleet T, Wagoner MP, Wang Q, Arslan SY, Yoder G, Ekert JE. Baran SW, et al. Among authors: brown pc. ALTEX. 2022;39(2):297–314. doi: 10.14573/altex.2112203. Epub 2022 Jan 21. ALTEX. 2022. PMID: 35064273 Free article.
IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making.
Chang X, Tan YM, Allen DG, Bell S, Brown PC, Browning L, Ceger P, Gearhart J, Hakkinen PJ, Kabadi SV, Kleinstreuer NC, Lumen A, Matheson J, Paini A, Pangburn HA, Petersen EJ, Reinke EN, Ribeiro AJS, Sipes N, Sweeney LM, Wambaugh JF, Wange R, Wetmore BA, Mumtaz M. Chang X, et al. Among authors: brown pc. Toxics. 2022 May 1;10(5):232. doi: 10.3390/toxics10050232. Toxics. 2022. PMID: 35622645 Free PMC article. Review.
Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro.
Salminen AT, Davis KJ, Felton RP, Nischal N, VonTungeln LS, Beland FA, Derr K, Brown PC, Ferrer M, Katz LM, Kleinstreuer NC, Leshin J, Manga P, Sadrieh N, Xia M, Fitzpatrick SC, Camacho L. Salminen AT, et al. Among authors: brown pc. Toxicol In Vitro. 2023 Sep;91:105630. doi: 10.1016/j.tiv.2023.105630. Epub 2023 Jun 13. Toxicol In Vitro. 2023. PMID: 37315744
CDER photosafety guidance for industry.
Jacobs AC, Brown PC, Chen C, Ellis A, Farrelly J, Osterberg R. Jacobs AC, et al. Among authors: brown pc. Toxicol Pathol. 2004 Jul-Aug;32 Suppl 2:17-8. doi: 10.1080/01926230490463821. Toxicol Pathol. 2004. PMID: 15503660
CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products.
Cruz CN, Tyner KM, Velazquez L, Hyams KC, Jacobs A, Shaw AB, Jiang W, Lionberger R, Hinderling P, Kong Y, Brown PC, Ghosh T, Strasinger C, Suarez-Sharp S, Henry D, Van Uitert M, Sadrieh N, Morefield E. Cruz CN, et al. Among authors: brown pc. AAPS J. 2013 Jul;15(3):623-8. doi: 10.1208/s12248-013-9466-6. Epub 2013 Mar 20. AAPS J. 2013. PMID: 23512727 Free PMC article.
112 results