Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Mark Powley"'
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
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
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
Autor:
Mark Powley
Publikováno v:
Regulatory Toxicology and Pharmacology. 71:295-300
(Quantitative) structure activity relationship [(Q)SAR] modeling is the primary tool used to evaluate the mutagenic potential associated with drug impurities. General recommendations regarding the use of (Q)SAR in regulatory decision making have rece
Publikováno v:
International Journal of Toxicology. 34:352-354
A continuing education (CE) course at the 2014 American College of Toxicology annual meeting covered the topic of (Quantitative) Structure–Activity Relationships [(Q)SAR]. The (Q)SAR methodologies use predictive computer modeling based on predefine
Publikováno v:
International Journal of Toxicology. 31:211-221
The timing of carcinogenicity studies in parallel with the clinical development of anti–human immunodeficiency virus (HIV) drugs has been flexible for most cases in the past. This includes postponement of the initiation of the studies and submissio
Publikováno v:
The Role of the Study Director in Nonclinical Studies
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::96d37700d313ce78196c324c0132014a
https://doi.org/10.1002/9781118873922.ch19
https://doi.org/10.1002/9781118873922.ch19
Autor:
Mark Powley, Robert E. Osterberg
Publikováno v:
Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8b4c347f3db8cffdc8a5c8f5093dcc1e
https://doi.org/10.1002/9781118517000.ch21
https://doi.org/10.1002/9781118517000.ch21
Autor:
Revd. Mark Powley
Consumerism is everywhere. It shapes the way we eat, shop, rest, think, love and believe. We can't escape it, but how can we live well in the midst of it? We are daily seduced by a 250 billion dollar marketing machine. But how often do we consider ho
Publikováno v:
Software Testing, Verification and Reliability. 3:125-148
A policy of rigorous unit testing as a foundation for the integration of software systems has been found to be effective, resulting in rapid integration and good overall quality of the final software and systems. However, there is little detailed inf