Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Lisa Beilke"'
Autor:
Arianna Bassan, Ronald Steigerwalt, Douglas Keller, Lisa Beilke, Paul M. Bradley, Frank Bringezu, William J. Brock, Leigh Ann Burns-Naas, Jon Chambers, Kevin Cross, Michael Dorato, Rosalie Elespuru, Douglas Fuhrer, Frances Hall, Jim Hartke, Gloria D. Jahnke, Felix M. Kluxen, Eric McDuffie, Friedemann Schmidt, Jean-Pierre Valentin, David Woolley, Doris Zane, Glenn J. Myatt
Publikováno v:
Frontiers in Toxicology, Vol 6 (2024)
The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the pres
Externí odkaz:
https://doaj.org/article/3419c3b90a414f7aafa8e7a2a11aedc0
Autor:
Jean-Pierre Valentin, Daniel P. Russo, David T. Szabo, Lidiya Stavitskaya, Patricia Ruiz, Craig Zwickl, Louise Neilson, Vinicius M. Alves, Candice Johnson, Andreas Bender, Arianna Bassan, Lennart T. Anger, Reena Sandhu, David Woolley, Lisa Beilke, Manuela Pavan, Raymond Kemper, Mark T. D. Cronin, Moiz Mumtaz, Glenn J. Myatt, Alexander Amberg, Yogesh Sabnis, Jui-Hua Hsieh, Markus Schaefer, Amy Pointon, Autumn Bernal, Julia Pletz
Publikováno v:
Comput Toxicol
The kidneys, heart and lungs are vital organ systems evaluated as part of acute or chronic toxicity assessments. New methodologies are being developed to predict these adverse effects based on in vitro and in silico approaches. This paper reviews the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6e41082bb951a3c41285999b6f292588
https://europepmc.org/articles/PMC9205464/
https://europepmc.org/articles/PMC9205464/
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:
Ernst Ahlberg, Tatyana Y. Doktorova, Alexis Parenty, Thomas Exner, David Woolley, Angela White, Alessandro Brigo, Scott Miller, Jason Magby, Rahul Parakhia, David W. Roberts, Thibaud Weiler, Raymond R. Tice, David Faulkner, Eckart Krupp, Candice Y. Johnson, Amanda Giddings, Ana Theresa Paulino, Jessica Whritenour, Véronique Gervais, Barry Hardy, Ian M. Fearon, Louise Neilson, Alexandre Paulino, Sarah Campbell, Shayne C. Gad, Sol Bobst, Reinhard Stidl, Liat Lomnitski, Anna Vuorinen, Lawrence Milchak, Craig Zwickl, Harald Schlecker, Wolfgang Muster, David T. Szabo, Lisa Beilke, Mark T. D. Cronin, Daniel Urbisch, Glenn J. Myatt, Joel P. Bercu, Robert A. Jolly, Brian A. Wall, Markus Fehr, Romualdo Benigni, Lennart T. Anger, Ian Crooks, Patricia Parris, Kevin P. Cross, Joerg Wichard, David Bower, Diana Suarez-Rodrigez, Jedd Hillegass, Catrin Hasselgren, Susanne Glowienke, Jordi Mestres
Publikováno v:
Regul Toxicol Pharmacol
The assessment of skin sensitization has evolved over the past few years to include in vitro assessments of key events along the adverse outcome pathway and opportunistically capitalize on the strengths of in silico methods to support a weight of evi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5fc9080fa2ddd4532dad416d216a1d7b
http://hdl.handle.net/10230/45587
http://hdl.handle.net/10230/45587
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:
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:
Markus Frericks, Franck Atienzar, Nichola Gellatly, Candice Y. Johnson, Lisa Beilke, Alessandro Brigo, Laura Custer, Brian A. Wall, Dave Bower, Penny Leavitt, Angela White, Helga Gerets, Ray Kemper, Krista L. Dobo, David Jones, Naomi L. Kruhlak, Ian Crooks, Tara S. Barton-Maclaren, Craig Zwickl, Mark T. D. Cronin, Kevin P. Cross, Michelle O. Kenyon, Jui-Hua Hsieh, Véronique Gervais, Anna Vuorinen, Andrea-Nicole Richarz, David Faulkner, Zoryana Cammerer, Ronald D. Snyder, Jedd Hillegass, Kristine L. Witt, James Harvey, Alexandre Paulino, Glenn J. Myatt, Phillip Bellion, Romualdo Benigni, Marie C. Fortin, Alexander Amberg, Robert A. Jolly, Ernst Ahlberg, Lidiya Stavitskaya, M. Vijayaray Reddy, Chia-Wen Hsu, Mark Powley, Tatyana Y. Doktorova, Scott Miller, Chandrika Moudgal, Masamitsu Honma, Benoît Schilter, Donald P. Quigley, David Woolley, Raymond R. Tice, Samantha E. Gad-McDonald, Pete Watts, Joerg Wichard, Reinhard Stidl, Joel P. Bercu, Andrew Teasdale, Wolfgang Muster, Catrin Hasselgren, Susanne Glowienke, Elena Lo Piparo, Yumi Akahori, Adam Woolley, Klaus Kümmerer, David T. Szabo, Jacky Van Gompel, Sunil Kulkarni, Alejandra Trejo-Martin, Lennart T. Anger, Scott A. Masten, Kevin A. Ford, Scott S. Auerbach, Ewan D. Booth
Publikováno v:
Regul Toxicol Pharmacol
Hasselgren, C, Ahlberg, E, Akahori, Y, Amberg, A, Anger, L T, Atienzar, F, Auerbach, S, Beilke, L, Bellion, P, Benigni, R, Bercu, J, Booth, E D, Bower, D, Brigo, A, Cammerer, Z, Cronin, M T D, Crooks, I, Cross, K P, Custer, L, Dobo, K, Doktorova, T, Faulkner, D, Ford, K A, Fortin, M C, Frericks, M, Gad-McDonald, S E, Gellatly, N, Gerets, H, Gervais, V, Glowienke, S, Van Gompel, J, Harvey, J S, Hillegass, J, Honma, M, Hsieh, J H, Hsu, C W, Barton-Maclaren, T S, Johnson, C, Jolly, R, Jones, D, Kemper, R, Kenyon, M O, Kruhlak, N L, Kulkarni, S A, Kümmerer, K, Leavitt, P, Masten, S, Miller, S, Moudgal, C, Muster, W, Paulino, A, Lo Piparo, E, Powley, M, Quigley, D P, Reddy, M V, Richarz, A N, Schilter, B, Snyder, R D, Stavitskaya, L, Stidl, R, Szabo, D T, Teasdale, A, Tice, R R, Trejo-Martin, A, Vuorinen, A, Wall, B A, Watts, P, White, A T, Wichard, J, Witt, K L, Woolley, A, Woolley, D, Zwickl, C & Myatt, G J 2019, ' Genetic toxicology in silico protocol ', Regulatory Toxicology and Pharmacology, vol. 107, no. 104403, 104403 . https://doi.org/10.1016/j.yrtph.2019.104403
Hasselgren, C, Ahlberg, E, Akahori, Y, Amberg, A, Anger, L T, Atienzar, F, Auerbach, S, Beilke, L, Bellion, P, Benigni, R, Bercu, J, Booth, E D, Bower, D, Brigo, A, Cammerer, Z, Cronin, M T D, Crooks, I, Cross, K P, Custer, L, Dobo, K, Doktorova, T, Faulkner, D, Ford, K A, Fortin, M C, Frericks, M, Gad-McDonald, S E, Gellatly, N, Gerets, H, Gervais, V, Glowienke, S, Van Gompel, J, Harvey, J S, Hillegass, J, Honma, M, Hsieh, J H, Hsu, C W, Barton-Maclaren, T S, Johnson, C, Jolly, R, Jones, D, Kemper, R, Kenyon, M O, Kruhlak, N L, Kulkarni, S A, Kümmerer, K, Leavitt, P, Masten, S, Miller, S, Moudgal, C, Muster, W, Paulino, A, Lo Piparo, E, Powley, M, Quigley, D P, Reddy, M V, Richarz, A N, Schilter, B, Snyder, R D, Stavitskaya, L, Stidl, R, Szabo, D T, Teasdale, A, Tice, R R, Trejo-Martin, A, Vuorinen, A, Wall, B A, Watts, P, White, A T, Wichard, J, Witt, K L, Woolley, A, Woolley, D, Zwickl, C & Myatt, G J 2019, ' Genetic toxicology in silico protocol ', Regulatory Toxicology and Pharmacology, vol. 107, no. 104403, 104403 . https://doi.org/10.1016/j.yrtph.2019.104403
In silico toxicology (IST) approaches to rapidly assess chemical hazard, and usage of such methods is increasing in all applications but especially for regulatory submissions, such as for assessing chemicals under REACH as well as the ICH M7 guidelin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::79c7543ee11579b9576d130b0cc8e19f
https://doi.org/10.1016/j.yrtph.2019.104403
https://doi.org/10.1016/j.yrtph.2019.104403
Autor:
Hans-Peter Spirkl, Michelle O. Kenyon, Alessandro Brigo, Dave Bower, Dennie S. Welch, Eric Dowdy, Naomi L. Kruhlak, Penny Leavitt, Angela White, Glenn J. Myatt, Sandy Weiner, Wolfgang Muster, Alexander Amberg, James Harvey, Kevin P. Cross, Jacky Van Gompel, Raymond Kemper, Joerg Wichard, Masamitsu Honma, Joel P. Bercu, M. Vijayaraj Reddy, Andrew Teasdale, Catrin Hasselgren, Lisa Beilke, Scott Miller, John Nicolette, Susanne Glowienke, Lidiya Stavitskaya, Robert A. Jolly, Kevin A. Ford, Krista L. Dobo, Mark Powley, Andreja Plaper, Laura Custer, Donald P. Quigley
Publikováno v:
Regulatory Toxicology and Pharmacology. :13-24
The ICH M7 guideline describes a consistent approach to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities. This paper outlines a series
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb24f74a2f8922885931c89451a7cc63
Autor:
Yogesh Sabnis, Lennart T. Anger, Jean-Pierre Valentin, Daniel P. Russo, Craig Zwickl, Joerg Wichard, Vinicius M. Alves, Nigel Greene, Arianna Bassan, Alexander Amberg, Markus Schaefer, Manuela Pavan, Jui-Hua Hsieh, Scott S. Auerbach, Raymond Kemper, Dominic P. Williams, Tobias Noeske, Mark T. D. Cronin, Glenn J. Myatt, David Woolley, Moiz Mumtaz, Julia Pletz, David T. Szabo, Lisa Beilke, Marlene T. Kim, Kevin P. Cross, Andreas Bender
Publikováno v:
Comput Toxicol
Hepatotoxicity is one of the most frequently observed adverse effects resulting from exposure to a xenobiotic. For example, in pharmaceutical research and development it is one of the major reasons for drug withdrawals, clinical failures, and discont
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::76b2067492830b7ca9e0623acacc5037
https://researchonline.ljmu.ac.uk/id/eprint/15480/1/1-s2.0-S2468111321000359-main.pdf
https://researchonline.ljmu.ac.uk/id/eprint/15480/1/1-s2.0-S2468111321000359-main.pdf
Autor:
Craig M. Zwickl, Jessica C. Graham, Robert A. Jolly, Arianna Bassan, Ernst Ahlberg, Alexander Amberg, Lennart T. Anger, Lisa Beilke, Phillip Bellion, Alessandro Brigo, Heather Burleigh-Flayer, Mark T.D. Cronin, Amy A. Devlin, Trevor Fish, Susanne Glowienke, Kamila Gromek, Agnes L. Karmaus, Ray Kemper, Sunil Kulkarni, Elena Lo Piparo, Federica Madia, Matthew Martin, Melisa Masuda-Herrera, Britt L. McAtee, Jordi Mestres, Lawrence Milchak, Chandrika Moudgal, Moiz Mumtaz, Wolfgang Muster, Louise Neilson, Grace Patlewicz, Alexandre Paulino, Alessandra Roncaglioni, Patricia Ruiz, David T. Szabo, Jean-Pierre Valentin, Ioanna Vardakou, David Woolley, Glenn J. Myatt
Acute toxicity in silico models are being used to support an increasing number of application areas including (1) product research and development, (2) product approval and registration as well as (3) the transport, storage and handling of chemicals.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::228d8a2c2c2985cfe6eb2948ef8fac53