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232 results

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ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup.
Bourcier T, McGovern T, Cavaliero T, Ebere G, Nishikawa A, Nishimura J, Ogawa K, Pasanen M, Vespa A, Van der Laan JW. Bourcier T, et al. Front Toxicol. 2024 Apr 11;6:1353783. doi: 10.3389/ftox.2024.1353783. eCollection 2024. Front Toxicol. 2024. PMID: 38665214 Free PMC article.
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: bourcier t. Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. Regul Toxicol Pharmacol. 2020. PMID: 32325112
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Ackley D, Birkebak J, Blumel J, Bourcier T, de Zafra C, Goodwin A, Halpern W, Herzyk D, Kronenberg S, Mauthe R, Shenton J, Shuey D, Wange RL. Ackley D, et al. Among authors: bourcier t. Regul Toxicol Pharmacol. 2023 Feb;138:105327. doi: 10.1016/j.yrtph.2022.105327. Epub 2022 Dec 28. Regul Toxicol Pharmacol. 2023. PMID: 36586472 Free article.
Pancreatic safety of incretin-based drugs--FDA and EMA assessment.
Egan AG, Blind E, Dunder K, de Graeff PA, Hummer BT, Bourcier T, Rosebraugh C. Egan AG, et al. Among authors: bourcier t. N Engl J Med. 2014 Feb 27;370(9):794-7. doi: 10.1056/NEJMp1314078. N Engl J Med. 2014. PMID: 24571751 Free article. No abstract available.
Improving carcinogenicity assessment.
Morton D, Bourcier T, Alden CL. Morton D, et al. Among authors: bourcier t. Toxicol Pathol. 2013 Feb;41(2):263-70. doi: 10.1177/0192623312464310. Epub 2012 Oct 17. Toxicol Pathol. 2013. PMID: 23076039
Reply to: Response from Australian Ophthalmological Surgical Trainees and Consultants to: Cataract Surgical Training in Europe: European Board of Ophthalmology Survey.
Bourcier T, Dhubhghaill SN, Yaïci R, Sanogo M, Lefebvre F, Aclimandos W, Asoklis R, Atilla H, Creuzot-Garcher C, Curtin D, Cvenkel B, Flanagan L, Kivelä TT, Costa RM, Priglinger S, Filipe HP, Stopa M, Strong B, Sturmer J, Tassignon MJ, Ivekovic R, Maino A. Bourcier T, et al. J Cataract Refract Surg. 2024 May 22. doi: 10.1097/j.jcrs.0000000000001490. Online ahead of print. J Cataract Refract Surg. 2024. PMID: 38776150 No abstract available.
Variation in eye care professional distribution across Europe, a survey.
Arnould L, Varsanyi B, Dervan E, Posarelli C, Filipe HP, Bourcier T, Wedrich A, Ivekovic R, Petrovski G, Porro GL, Laganovska G, Balciuniene VJ, Mrukwa-Kominek E, Paust K, Roemer S, Haefliger IO, Atilla H, Ursell P, Cvenkel B, Kiilgaard J, Grupcheva C, Furdova A, Claeys M, Maresova K, Mercieca F, Sepp T, Parikakis E, Burcea M, Aclimandos W, Khawaja AP. Arnould L, et al. Among authors: bourcier t. Eye (Lond). 2024 Mar 12. doi: 10.1038/s41433-024-03010-7. Online ahead of print. Eye (Lond). 2024. PMID: 38472379 No abstract available.
232 results