Zobrazeno 1 - 10
of 32
pro vyhledávání: '"Laura Custer"'
Autor:
Véronique Thybaud, Kerry L. Dearfield, Roland Froetschl, Jennifer C. Sasaki, Mirjam Luijten, George E. Johnson, John Nicolette, Michelle R. Embry, Laura Custer, Gladys Ouedraogo, Raja S. Settivari
Publikováno v:
Environmental and Molecular Mutagenesis. 62:512-525
We present a hypothetical case study to examine the use of a next-generation framework developed by the Genetic Toxicology Technical Committee of the Health and Environmental Sciences Institute for assessing the potential risk of genetic damage from
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a94a80d1984a7afa084ed6b9f60639c4
https://doi.org/10.1002/em.22467
https://doi.org/10.1002/em.22467
Autor:
Alejandra Trejo-Martin, Joel P. Bercu, Andrew Thresher, Rachael E. Tennant, Robert F. Thomas, Kevin Cross, Andreas Czich, Kerstin Waese, John J. Nicolette, Joel Murray, Paul Sonders, Alison Kondratiuk, Jennifer R. Cheung, Dean Thomas, Anthony Lynch, James Harvey, Susanne Glowienke, Laura Custer, Patricia A. Escobar
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 135
Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive using in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been of recent concern as impurities in phar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1759d9f286318961dbbadf9f25dd9d92
https://pubmed.ncbi.nlm.nih.gov/35998738
https://pubmed.ncbi.nlm.nih.gov/35998738
Autor:
John Nicolette, Donald P. Quigley, Alejandra Trejo-Martin, David Woolley, Lidiya Stavitskaya, Lennart T. Anger, Dave Bower, Jennifer C. Sasaki, Candice Y. Johnson, Michelle O. Kenyon, Glenn J. Myatt, Sandy Weiner, Naomi L. Kruhlak, Susanne Glowienke, Véronique Gervais, Lisa Beilke, Angela White, Penny Leavitt, Roxanne Andaya, James Harvey, Joel P. Bercu, Andrew Teasdale, Jacky Van Gompel, Raymond Kemper, Kevin P. Cross, Scott Miller, Catrin Hasselgren, Barber Christopher Gordon, M. Vijayaraj Reddy, Joerg Wichard, Robert A. Jolly, Alessandro Brigo, Dennie S. Welch, Alexander Amberg, Russell Naven, Masamitsu Honma, Alexis Parenty, Stephen Gomez, Zoryanna Cammerer, Mark Powley, Laura Custer, Krista L. Dobo, Helga Gerets, Wolfgang Muster
Publikováno v:
Regulatory toxicology and pharmacology : RTP
The International Council for Harmonization (ICH) M7 guideline describes a hazard assessment process for impurities that have the potential to be present in a drug substance or drug product. In the absence of adequate experimental bacterial mutagenic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc40f205a6b475a7fdd8889147e338e1
https://doi.org/10.1016/j.yrtph.2018.12.007
https://doi.org/10.1016/j.yrtph.2018.12.007
Autor:
Junguo Zhou, Paul Butler, Meredith Crosby, Laura Aschenbrenner, Jim Blank, Jonathan G. Moggs, Vincent L. Reynolds, Kyle L. Kolaja, Derek D. Best, Dana Shuey, Matthew M. Abernathy, Terry R. Van Vleet, Chelsea Snyder, Patricia A. Escobar, Timothy K. Hart, Laura Custer
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 117
Pharmaceutic products designed to perturb the function of epigenetic modulators have been approved by regulatory authorities for treatment of advanced cancer. While the predominant effort in epigenetic drug development continues to be in oncology, no
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d0c03ba3f1ed7746ed6a53efdd5ecdd
https://pubmed.ncbi.nlm.nih.gov/32911461
https://pubmed.ncbi.nlm.nih.gov/32911461
Autor:
U. Hemmann, Jim Saul, James Whitwell, B.M. van der Leede, Stephen D. Dertinger, P. Escobar, Andreas Zeller, Julia Kenny, Robert Smith, David P. Lovell, R. Fiedler, Laura Custer, Mick D. Fellows
A database of micronuclei counts for historical negative control data from rat in vivo micronuclei tests performed in 10 different laboratories was established. Data were available from over 4000 negative control rats from 10 laboratories. The mean f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::26ce64fec9cd31402b79b499b439c2ac
Autor:
Kyle P. Glover, Yumi Akahori, Michelle O. Kenyon, David Jones, Angela White, Patricia Ruiz, Dave Bower, Mark Powley, Janet Moser, Naomi L. Kruhlak, Diana Suarez-Rodriguez, Laura Custer, Chia Wen Hsu, Masamitsu Honma, Joel P. Bercu, Steve Gutsell, Krista L. Dobo, Bernhard Majer, Andrew Teasdale, Lidiya Stavitskaya, Aynur O. Aptula, Barry Hardy, Candice Y. Johnson, Scott S. Auerbach, Nichola Gellatly, Rositsa Serafimova, David Allen, Samantha E. Gad-McDonald, Alessandro Brigo, Lennart T. Anger, Kevin P. Cross, Pete Watts, Louise Neilson, Wendy Simpson, Jedd Hillegass, Véronique Gervais, Penny Leavitt, Jui-Hua Hsieh, Kristine L. Witt, Reinhard Stidl, Magdalena Dettwiler, K. Hughes, Romualdo Benigni, Lisa Beilke, Marlene T. Kim, Scott A. Masten, Adam Woolley, Phillip Bellion, Kevin A. Ford, David T. Szabo, Alexander Amberg, Anna Vuorinen, Brian A. Wall, Mark T. D. Cronin, Marie C. Fortin, Zoryana Cammerer, Benoît Schilter, Glenn J. Myatt, Klaus Kümmerer, Ernst Ahlberg, Grace Patlewicz, M. Vijayaraj Reddy, Craig Zwickl, Donald P. Quigley, David Woolley, Tudor I. Oprea, Jacky Van Gompel, Ewan D. Booth, Alexandre Paulino, Wolfgang Muster, Sunil Kulkarni, Alejandra Trejo-Martin, Moiz Mumtaz, Andrea Richarz, Joerg Wichard, James Harvey, Susanne Glowienke, Elena Lo Piparo, Natalie Burden, Catrin Hasselgren, Jean Pierre Valentin, Robert A. Jolly, Scott Miller, Ray Kemper
Publikováno v:
Myatt, G J, Ahlberg, E, Akahori, Y, Allen, D, Amberg, A, Anger, L T, Aptula, A, Auerbach, S, Beilke, L, Bellion, P, Benigni, R, Bercu, J, Booth, E D, Bower, D, Brigo, A, Burden, N, Cammerer, Z, Cronin, M T D, Cross, K P, Custer, L, Dettwiler, M, Dobo, K, Ford, K A, Fortin, M C, Gad-McDonald, S E, Gellatly, N, Gervais, V, Glover, K P, Glowienke, S, Van Gompel, J, Gutsell, S, Hardy, B, Harvey, J S, Hillegass, J, Honma, M, Hsieh, J H, Hsu, C W, Hughes, K, Johnson, C, Jolly, R, Jones, D, Kemper, R, Kenyon, M O, Kim, M T, Kruhlak, N L, Kulkarni, S A, Kümmerer, K, Leavitt, P, Majer, B, Masten, S, Miller, S, Moser, J, Mumtaz, M, Muster, W, Neilson, L, Oprea, T I, Patlewicz, G, Paulino, A, Lo Piparo, E, Powley, M, Quigley, D P, Reddy, M V, Richarz, A N, Ruiz, P, Schilter, B, Serafimova, R, Simpson, W, Stavitskaya, L, Stidl, R, Suarez-Rodriguez, D, Szabo, D T, Teasdale, A, Trejo-Martin, A, Valentin, J P, Vuorinen, A, Wall, B A, Watts, P, White, A T, Wichard, J, Witt, K L, Woolley, A, Woolley, D, Zwickl, C & Hasselgren, C 2018, ' In silico toxicology protocols ' Regulatory toxicology and pharmacology : RTP, vol 96, pp. 1-17 . DOI: 10.1016/j.yrtph.2018.04.014
Myatt, G J, Ahlberg, E, Akahori, Y, Allen, D, Amberg, A, Anger, L T, Aptula, A, Auerbach, S, Beilke, L, Bellion, P, Benigni, R, Bercu, J, Booth, E D, Bower, D, Brigo, A, Burden, N, Cammerer, Z, Cronin, M T D, Cross, K P, Custer, L, Dettwiler, M, Dobo, K, Ford, K A, Fortin, M C, Gad-McDonald, S E, Gellatly, N, Gervais, V, Glover, K P, Glowienke, S, Van Gompel, J, Gutsell, S, Hardy, B, Harvey, J S, Hillegass, J, Honma, M, Hsieh, J H, Hsu, C W, Hughes, K, Johnson, C, Jolly, R, Jones, D, Kemper, R, Kenyon, M O, Kim, M T, Kruhlak, N L, Kulkarni, S A, Kümmerer, K, Leavitt, P, Majer, B, Masten, S, Miller, S, Moser, J, Mumtaz, M, Muster, W, Neilson, L, Oprea, T I, Patlewicz, G, Paulino, A, Lo Piparo, E, Powley, M, Quigley, D P, Reddy, M V, Richarz, A N, Ruiz, P, Schilter, B, Serafimova, R, Simpson, W, Stavitskaya, L, Stidl, R, Suarez-Rodriguez, D, Szabo, D T, Teasdale, A, Trejo-Martin, A, Valentin, J P, Vuorinen, A, Wall, B A, Watts, P, White, A T, Wichard, J, Witt, K L, Woolley, A, Woolley, D, Zwickl, C & Hasselgren, C 2018, ' In silico toxicology protocols ', Regulatory toxicology and pharmacology : RTP, vol. 96, pp. 1-17 . https://doi.org/10.1016/j.yrtph.2018.04.014
Myatt, G J, Ahlberg, E, Akahori, Y, Allen, D, Amberg, A, Anger, L T, Aptula, A, Auerbach, S, Beilke, L, Bellion, P, Benigni, R, Bercu, J, Booth, E D, Bower, D, Brigo, A, Burden, N, Cammerer, Z, Cronin, M T D, Cross, K P, Custer, L, Dettwiler, M, Dobo, K, Ford, K A, Fortin, M C, Gad-McDonald, S E, Gellatly, N, Gervais, V, Glover, K P, Glowienke, S, Van Gompel, J, Gutsell, S, Hardy, B, Harvey, J S, Hillegass, J, Honma, M, Hsieh, J H, Hsu, C W, Hughes, K, Johnson, C, Jolly, R, Jones, D, Kemper, R, Kenyon, M O, Kim, M T, Kruhlak, N L, Kulkarni, S A, Kümmerer, K, Leavitt, P, Majer, B, Masten, S, Miller, S, Moser, J, Mumtaz, M, Muster, W, Neilson, L, Oprea, T I, Patlewicz, G, Paulino, A, Lo Piparo, E, Powley, M, Quigley, D P, Reddy, M V, Richarz, A N, Ruiz, P, Schilter, B, Serafimova, R, Simpson, W, Stavitskaya, L, Stidl, R, Suarez-Rodriguez, D, Szabo, D T, Teasdale, A, Trejo-Martin, A, Valentin, J P, Vuorinen, A, Wall, B A, Watts, P, White, A T, Wichard, J, Witt, K L, Woolley, A, Woolley, D, Zwickl, C & Hasselgren, C 2018, ' In silico toxicology protocols ', Regulatory toxicology and pharmacology : RTP, vol. 96, pp. 1-17 . https://doi.org/10.1016/j.yrtph.2018.04.014
The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related pred
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e30474fda768266769a029d23592f910
https://doi.org/10.1016/j.yrtph.2018.04.014
https://doi.org/10.1016/j.yrtph.2018.04.014
Autor:
Michelle O. Kenyon, Melisa Masuda-Herrera, Angela White, Véronique Thybaud, John Nicolette, Robert A. Jolly, Susanne Glowienke, Sheila M. Galloway, P. Parris, P. Heard, Elizabeth A. Martin, Esther Vock, Krista L. Dobo, Laura Custer, James Harvey, W. Ku, Joel P. Bercu, Andrew Teasdale
Publikováno v:
Regulatory Toxicology and Pharmacology. 94:172-182
This paper provides compound-specific toxicology limits for 20 widely used synthetic reagents and common by-products that are potential impurities in drug substances. In addition, a 15 μg/day class-specific limit was developed for monofunctional alk
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b57c35386b7c9abf27d6c22b94a88b02
https://doi.org/10.1016/j.yrtph.2018.02.001
https://doi.org/10.1016/j.yrtph.2018.02.001
Autor:
Steven M. Bryce, Laura Custer, Kerry L. Dearfield, Carole L. Yauk, Giel Hendriks, Ashley Allemang, Sheila M. Galloway, Maik Schuler, Stefan Pfuhler, Patricia A Escobar, Azeddine Elhajouji, Gladys Ouedraogo, Albert J. Fornace, Heng-Hong Li, Jennifer C. Sasaki, Daniel J Roberts, Yasmin Dietz, Ulrike Hemmann, Jan van Benthem, Véronique Thybaud, Roland Froetschl, Lauren Peel, Mirjam Luijten
In May 2017, the Health and Environmental Sciences Institute's Genetic Toxicology Technical Committee hosted a workshop to discuss whether mode of action (MOA) investigation is enhanced through the application of the adverse outcome pathway (AOP) fra
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94120698a05b8acf2acfae209b20a2b1
http://hdl.handle.net/10029/623463
http://hdl.handle.net/10029/623463
Autor:
Lisa Beilke, Lidiya Stavitskaya, Penny Leavitt, Alexander Amberg, Donald P. Quigley, Angela White, James Harvey, Naomi L. Kruhlak, Raymond Kemper, Craig Zwickl, Claire L. Neilan, Ernst Ahlberg, Kevin P. Cross, Joerg Wichard, Glenn J. Myatt, Dana Shuey, Hans-Peter Spirkl, Michelle O. Kenyon, Masamitsu Honma, Robert A. Jolly, David Bower, Elisabeth Joossens, Jacky Van Gompel, Lara Kuhnke, Laura Custer, Kevin A. Ford, Russell T. Naven, Andrew Teasdale
Publikováno v:
Regulatory Toxicology and Pharmacology. 77:1-12
Statistical-based and expert rule-based models built using public domain mutagenicity knowledge and data are routinely used for computational (Q)SAR assessments of pharmaceutical impurities in line with the approach recommended in the ICH M7 guidelin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::32e433017dbcf484af3c46d7c78df622
https://doi.org/10.1016/j.yrtph.2016.02.003
https://doi.org/10.1016/j.yrtph.2016.02.003
Autor:
Glenn J. Myatt, Joel P. Bercu, Andrew Teasdale, Lidiya Stavitskaya, Laura Custer, David J. Snodin, Masamitsu Honma, Lennart T. Anger, Angela White, Joerg Wichard, Michelle O. Kenyon, Donald P. Quigley, Robert A. Jolly, Naomi L. Kruhlak, Kevin P. Cross, Alejandra Trejo-Martin, Alexander Amberg, Catrin Hasselgren, Scott Miller, Penny Leavitt, Candice Y. Johnson, David Bower, James Harvey
Publikováno v:
Mutagenesis. 34(1)
(Quantitative) structure-activity relationship or (Q)SAR predictions of DNA-reactive mutagenicity are important to support both the design of new chemicals and the assessment of impurities, degradants, metabolites, extractables and leachables, as wel
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7163312caa0a9575ef60575d6b463ac4
https://pubmed.ncbi.nlm.nih.gov/30189015
https://pubmed.ncbi.nlm.nih.gov/30189015