Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Sandy Weiner"'
Autor:
Junguo Zhou, Sandra De Jonghe, Ellen E. Codd, Sandy Weiner, David Gallacher, Paul Stahle, Michael F. Kelley, Edwin K. Kuffner, Christopher M. Flores, Gary E. Eichenbaum
Publikováno v:
Regulatory toxicology and pharmacology : RTP.
JNJ-10450232 (NTM-006) is a new molecular entity that is structurally related to acetaminophen. A comprehensive non-clinical safety program was conducted to support first-in-human and clinical efficacy studies based on preclinical data suggesting tha
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::adde6c1620b375340ef6e96be6ff72e1
https://pubmed.ncbi.nlm.nih.gov/36608923
https://pubmed.ncbi.nlm.nih.gov/36608923
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:
Dana S. Gaffney, Eileen Vesely, David Pocalyko, Kurtis Bachman, Karla Wiehagen, Glenn Cowley, Victoria Wong, Prashanth Gokare, Peggy Guzzie-Peck, Sandy Weiner, Ann De Smedt, Jacqueline Kinyamu-Akunda, Tammy Bush, Zhuming Zhang, Robert Schulingkamp, Sylvia F. Boj, Rene Overmeer, Carla Verissimo, Roshni Nair
Publikováno v:
Cancer Research. 82:1416-1416
Colorectal cancer (CRC) is the second most common cause of cancer-related deaths worldwide. The disease-initiating event in most CRC cases is the loss of function (LOF) of the adenomatous polyposis coli (APC) gene, accounting for 70-80% of CRC. Strat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::24259b77bc55319b20142cd76fcdbba3
https://doi.org/10.1158/1538-7445.am2022-1416
https://doi.org/10.1158/1538-7445.am2022-1416
Autor:
Kathleen De Vlieger, Ann Schuermans, Bas-jan van der Leede, Helena Geys, Marjolein van Heerden, Sandra De Jonghe, Terry Van Doninck, Fetene Tekle, Jacky Van Gompel, Sandy Weiner
Publikováno v:
Environmental and Molecular Mutagenesis
Acetaminophen, a nonmutagenic compound as previously concluded from bacteria, in vitro mammalian cell, and in vivo transgenic rat assays, presented a good profile as a nonmutagenic reference compound for use in the international multilaboratory Pig
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3b1bc3f3b77f93d67798463dd79a510
https://pubmed.ncbi.nlm.nih.gov/32187737
https://pubmed.ncbi.nlm.nih.gov/32187737
Autor:
Véronique Thybaud, Christopher S Farabaugh, Frank Le Curieux, John Nicolette, Javed A. Bhalli, Melanie Guérard, Marilyn J. Aardema, George R. Douglas, David P. Lovell, Leon F. Stankowski, George E. Johnson, Andrew Williams, Mirjam Luijten, Sandy Weiner, Kristine L. Witt, Carol Beevers, Jasmin Lott, Francesco Marchetti, Patricia A. Escobar, Alexandra S. Long, Daniel J Roberts, Robert R. Young, David Kirkland, Rohan Kulkarni, Stefan Pfuhler, Matthew J. LeBaron, Dan D. Levy
A database of 91 chemicals with published data from both transgenic rodent mutation (TGR) and rodent comet assays has been compiled. The objective was to compare the sensitivity of the two assays for detecting genotoxicity. Critical aspects of study
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e5685a1dd3e8efa3d80cab9943695dcf
https://openaccess.sgul.ac.uk/id/eprint/110683/1/1-s2.0-S1383571818304169-main.pdf
https://openaccess.sgul.ac.uk/id/eprint/110683/1/1-s2.0-S1383571818304169-main.pdf
Autor:
Catherine O'Leary-Steele, Sandy Weiner, Susanne Glowienke, Alessandro Brigo, Alexis Parenty, Hans-Peter Spirkl, Robert A. Jolly, Ray Kemper, Susanne A. Stalford, Richard V. Williams, Alexander Amberg, Nigel Greene, Laurence Coquin, Amanda Giddings, Joerg Wichard
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 76
At the confluence of predictive and regulatory toxicologies, negative predictions may be the thin green line that prevents populations from being exposed to harm. Here, two novel approaches to making confident and robust negative in silico prediction
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad22d7c6e9bd66b7ac82a4f5aea307a4
https://pubmed.ncbi.nlm.nih.gov/26785392
https://pubmed.ncbi.nlm.nih.gov/26785392
Autor:
Hans-Peter Spirkl, Barber Christopher Gordon, Amanda Giddings, Thierry Hanser, Crina Heghes, Alexis Parenty, Alex Harding, Jonathan D. Vessey, Susanne Glowienke, Alessandro Brigo, Alex Cayley, Alexander Amberg, Sandy Weiner, Ray Kemper, Joerg Wichard, Stephane Werner, Nigel Greene
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 76
The relative wealth of bacterial mutagenicity data available in the public literature means that in silico quantitative/qualitative structure activity relationship (QSAR) systems can readily be built for this endpoint. A good means of evaluating the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::012d190db507f95ab87c7bfb8c923882
https://pubmed.ncbi.nlm.nih.gov/26708083
https://pubmed.ncbi.nlm.nih.gov/26708083
Autor:
James Harvey, Michelle O. Kenyon, Angela White, Sandy Weiner, Catrin Hasselgren, Jennifer B. Munzner, Krista L. Dobo, Robert A. Jolly, Robin Neft, Susanne Glowienke, Charlotta Fred, Nigel Greene, Wolfgang Muster, M. Vijayaraj Reddy
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 62(3)
With the increasing emphasis on identification and low level control of potentially genotoxic impurities (GTIs), there has been increased use of structure-based assessments including application of computerized models. To date many publications have
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::32c266709a2ab25a4c0007518191a173
https://pubmed.ncbi.nlm.nih.gov/22321701
https://pubmed.ncbi.nlm.nih.gov/22321701
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