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Nonclinical safety evaluation of a novel ionizable lipid for mRNA delivery.
Toxicol Appl Pharmacol. 2022 Sep 15;451:116143. doi: 10.1016/j.taap.2022.116143. Epub 2022 Jul 16.
Toxicol Appl Pharmacol. 2022.
PMID: 35843341
Computational Models for Human and Animal Hepatotoxicity with a Global Application Scope.
Mulliner D, Schmidt F, Stolte M, Spirkl HP, Czich A, Amberg A.
Mulliner D, et al. Among authors: spirkl hp.
Chem Res Toxicol. 2016 May 16;29(5):757-67. doi: 10.1021/acs.chemrestox.5b00465. Epub 2016 Apr 6.
Chem Res Toxicol. 2016.
PMID: 26914516
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It's difficult, but important, to make negative predictions.
Williams RV, Amberg A, Brigo A, Coquin L, Giddings A, Glowienke S, Greene N, Jolly R, Kemper R, O'Leary-Steele C, Parenty A, Spirkl HP, Stalford SA, Weiner SK, Wichard J.
Williams RV, et al. Among authors: spirkl hp.
Regul Toxicol Pharmacol. 2016 Apr;76:79-86. doi: 10.1016/j.yrtph.2016.01.008. Epub 2016 Jan 16.
Regul Toxicol Pharmacol. 2016.
PMID: 26785392
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Evaluation of a statistics-based Ames mutagenicity QSAR model and interpretation of the results obtained.
Barber C, Cayley A, Hanser T, Harding A, Heghes C, Vessey JD, Werner S, Weiner SK, Wichard J, Giddings A, Glowienke S, Parenty A, Brigo A, Spirkl HP, Amberg A, Kemper R, Greene N.
Barber C, et al. Among authors: spirkl hp.
Regul Toxicol Pharmacol. 2016 Apr;76:7-20. doi: 10.1016/j.yrtph.2015.12.006. Epub 2015 Dec 18.
Regul Toxicol Pharmacol. 2016.
PMID: 26708083
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Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity.
Ahlberg E, Amberg A, Beilke LD, Bower D, Cross KP, Custer L, Ford KA, Van Gompel J, Harvey J, Honma M, Jolly R, Joossens E, Kemper RA, Kenyon M, Kruhlak N, Kuhnke L, Leavitt P, Naven R, Neilan C, Quigley DP, Shuey D, Spirkl HP, Stavitskaya L, Teasdale A, White A, Wichard J, Zwickl C, Myatt GJ.
Ahlberg E, et al. Among authors: spirkl hp.
Regul Toxicol Pharmacol. 2016 Jun;77:1-12. doi: 10.1016/j.yrtph.2016.02.003. Epub 2016 Feb 13.
Regul Toxicol Pharmacol. 2016.
PMID: 26879463
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Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses.
Amberg A, Beilke L, Bercu J, Bower D, Brigo A, Cross KP, Custer L, Dobo K, Dowdy E, Ford KA, Glowienke S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Nicolette J, Plaper A, Powley M, Quigley DP, Reddy MV, Spirkl HP, Stavitskaya L, Teasdale A, Weiner S, Welch DS, White A, Wichard J, Myatt GJ.
Amberg A, et al. Among authors: spirkl hp.
Regul Toxicol Pharmacol. 2016 Jun;77:13-24. doi: 10.1016/j.yrtph.2016.02.004. Epub 2016 Feb 11.
Regul Toxicol Pharmacol. 2016.
PMID: 26877192
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