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Using default methodologies to derive an acceptable daily exposure (ADE).
Faria EC, Bercu JP, Dolan DG, Morinello EJ, Pecquet AM, Seaman C, Sehner C, Weideman PA. Faria EC, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S28-38. doi: 10.1016/j.yrtph.2016.05.026. Epub 2016 May 24. Regul Toxicol Pharmacol. 2016. PMID: 27233926 Review.
A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Hayes EP, Jolly RA, Faria EC, Barle EL, Bercu JP, Molnar LR, Naumann BD, Olson MJ, Pecquet AM, Sandhu R, Shipp BK, Sussman RG, Weideman PA. Hayes EP, et al. Among authors: bercu jp. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S39-47. doi: 10.1016/j.yrtph.2016.06.001. Epub 2016 Jun 3. Regul Toxicol Pharmacol. 2016. PMID: 27267172 Review.
In silico toxicology protocols.
Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin JP, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C. Myatt GJ, et al. Among authors: bercu j. Regul Toxicol Pharmacol. 2018 Jul;96:1-17. doi: 10.1016/j.yrtph.2018.04.014. Epub 2018 Apr 17. Regul Toxicol Pharmacol. 2018. PMID: 29678766 Free PMC article.
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?
Amberg A, Anger LT, Bercu J, Bower D, Cross KP, Custer L, Harvey JS, Hasselgren C, Honma M, Johnson C, Jolly R, Kenyon MO, Kruhlak NL, Leavitt P, Quigley DP, Miller S, Snodin D, Stavitskaya L, Teasdale A, Trejo-Martin A, White AT, Wichard J, Myatt GJ. Amberg A, et al. Among authors: bercu j. Mutagenesis. 2019 Mar 6;34(1):67-82. doi: 10.1093/mutage/gey020. Mutagenesis. 2019. PMID: 30189015 Free PMC article.
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.
Amberg A, Andaya RV, Anger LT, Barber C, Beilke L, Bercu J, Bower D, Brigo A, Cammerer Z, Cross KP, Custer L, Dobo K, Gerets H, Gervais V, Glowienke S, Gomez S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Johnson C, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Naven R, Nicolette J, Parenty A, Powley M, Quigley DP, Reddy MV, Sasaki JC, Stavitskaya L, Teasdale A, Trejo-Martin A, Weiner S, Welch DS, White A, Wichard J, Woolley D, Myatt GJ. Amberg A, et al. Among authors: bercu j. Regul Toxicol Pharmacol. 2019 Mar;102:53-64. doi: 10.1016/j.yrtph.2018.12.007. Epub 2018 Dec 15. Regul Toxicol Pharmacol. 2019. PMID: 30562600 Free PMC article.
Genetic toxicology in silico protocol.
Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ. Hasselgren C, et al. Among authors: bercu j. Regul Toxicol Pharmacol. 2019 Oct;107:104403. doi: 10.1016/j.yrtph.2019.104403. Epub 2019 Jun 11. Regul Toxicol Pharmacol. 2019. PMID: 31195068 Free PMC article.
In Vivo Mutagenicity Testing of Arylboronic Acids and Esters.
Masuda-Herrera MJ, Dobo KL, Kenyon MO, Kenny JD, Galloway SM, Escobar PA, Reddy MV, Jolly RA, Trejo-Martin A, Brown C, Mckeon M, Young M, Bruce S, Pant K, Dutta A, Kulkarni R, Bercu JP. Masuda-Herrera MJ, et al. Among authors: bercu jp. Environ Mol Mutagen. 2019 Dec;60(9):766-777. doi: 10.1002/em.22320. Epub 2019 Aug 17. Environ Mol Mutagen. 2019. PMID: 31335992
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.
Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Among authors: bercu j. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
44 results