Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Melisa Masuda"'
Autor:
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Jessica Graham, Esther Johann, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Eric Tien, Maureen Cruz, Lee Nagao
Publikováno v:
Critical Reviews in Toxicology. 52:125-138
During the toxicological assessment of extractables and leachables in drug products, localized hazards such as irritation or sensitization may be identified. Typically, because of the low concentration at which leachables occur in pharmaceuticals, ir
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::79a6a7a140e0285b747a1ffba19dc2da
https://doi.org/10.1080/10408444.2022.2065966
https://doi.org/10.1080/10408444.2022.2065966
Autor:
Joel P. Bercu, Melisa Masuda-Herrera, Alejandra Trejo-Martin, Priyanka Sura, Robert Jolly, Michelle Kenyon, Rob Thomas, David J. Ponting, David Snodin, Gregor Tuschl, Stephanie Simon, Kathleen De Vlieger, Richard Hutchinson, Andreas Czich, Susanne Glowienke, M. Vijayaraj Reddy, Sandra Johanssen, Esther Vock, Nancy Claude, Richard J. Weaver
Publikováno v:
Regulatory Toxicology and Pharmacology. :105415
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2ee8f7358994d33dfefa7e612fd27f78
https://doi.org/10.1016/j.yrtph.2023.105415
https://doi.org/10.1016/j.yrtph.2023.105415
Autor:
Robert A. Jolly, Suren Bandara, Joel Bercu, Courtney M. Callis, David G. Dolan, Jessica Graham, Diem HaMai, Ester Lovsin Barle, Andrew Maier, Melisa Masuda-Herrera, Chandrika Moudgal, Jillian A. Parker, John Reichard, Reena Sandhu, Ernest S. Fung
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 134
Endogenous substances, such as fatty, amino, and nucleic acids, are often purposefully used in parenterally pharmaceuticals, but may be present as impurities. Currently, no consensus guidance exists on setting impurity limits for these substances. Sp
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0a2bcf6e3588100ffbd92c6f51b5bf1c
https://pubmed.ncbi.nlm.nih.gov/35964842
https://pubmed.ncbi.nlm.nih.gov/35964842
Autor:
Joel P. Bercu, Ailis Maisey, Alejandra Trejo-Martin, Melisa Masuda-Herrera, John Nicolette, Erika Udovic, Elizabeth A. Martin, Eric Dowdy, James Harvey, Angela White, Susanne Glowienke, Michelle O. Kenyon, Jessica C. Graham, Mark W. Powley, Patricia Parris
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 126
The presence of impurities in drugs is unavoidable. As impurities offer no direct benefit to the patient, it is critical that impurities do not compromise patient safety. Current guidelines on the derivation of acceptable impurity levels leave aspect
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b37d8297b148acddb2ccc507898137f
https://pubmed.ncbi.nlm.nih.gov/34363920
https://pubmed.ncbi.nlm.nih.gov/34363920
Autor:
Colin Owens, Jessica C. Graham, Russell Naven, Glenn J. Myatt, Joel P. Bercu, Raymond Kemper, Iris van de Gevel, Surya Hari Lal, Kathleen Vriens, Melisa Masuda-Herrera, Phillip Bellion, Alejandra Trejo-Martin, Sarah Whalley, Lawrence Milchak, Richard L. Marchese Robinson, Anna Vuorinen, Catrin Hasselgren, Pierre Ferrer, William A. Hawkins, Matthew Schmitz, Kamila Gromek, Jean Lord
Publikováno v:
Regul Toxicol Pharmacol
This study assesses whether currently available acute oral toxicity (AOT) in silico models, provided by the widely employed Leadscope software, are fit-for-purpose for categorization and labelling of chemicals. As part of this study, a large data set
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::964e311259d8ebd3de6475fb86827f15
https://pubmed.ncbi.nlm.nih.gov/35474000
https://pubmed.ncbi.nlm.nih.gov/35474000
Autor:
Gregory L. Erexson, Kim Li, Brad Stanard, Melisa Masuda-Herrera, Susanne Glowienke, Thomas Broschard, Amanda Giddings, Geraldine Whelan, Lee M. Nagao, Uma S. Bruen, Maureen T. Cruz, David G. Dolan, Cheryl L. M. Stults, Patricia Parris, Courtney M. Callis, Elizabeth A. Martin, Ornella Binazon, Joel P. Bercu
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 118
Leachables from pharmaceutical container closure systems are a subset of impurities that present in drug products and may pose a risk to patients or compromise product quality. Extractable studies can identify potential leachables, and extractables a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0a76c2852883a67d50d9895f24170da7
https://pubmed.ncbi.nlm.nih.gov/33038429
https://pubmed.ncbi.nlm.nih.gov/33038429
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:
David J. Ponting, Michelle O. Kenyon, Melisa Masuda-Herrera, Angela White, Robert Thomas, Maria Augusta C. Rodrigues, Joel P. Bercu, Fernanda Waechter, Andreas Czich, George E. Johnson, Kevin P. Cross, Susanne Glowienke
Publikováno v:
Regulatory Toxicology and Pharmacology. 123:104926
The ICH M7(R1) guideline describes a framework to assess the carcinogenic risk of mutagenic and carcinogenic pharmaceutical impurities following less-than-lifetime (LTL) exposures. This LTL framework is important as many pharmaceuticals are not admin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1bdcf2cf19985685ebb95b1b7bb52a01
https://doi.org/10.1016/j.yrtph.2021.104926
https://doi.org/10.1016/j.yrtph.2021.104926
Autor:
Michelle O. Kenyon, Patricia A. Escobar, Rohan Kulkarni, Melisa Masuda-Herrera, Aparajita Dutta, Megan Young, M. Vijayaraj Reddy, Joel P. Bercu, Robert A. Jolly, Caren Brown, Shannon W. Bruce, Julia Kenny, Kamala Pant, Krista L. Dobo, Marie McKeon, Alejandra Trejo-Martin, Sheila M. Galloway
Publikováno v:
Environmental and molecular mutagenesisREFERENCES. 60(9)
Arylboronic acids and esters (referred to collectively as arylboronic compounds) are commonly used intermediates in the synthesis of pharmaceuticals but pose a challenge for chemical syntheses because they are often positive for bacterial mutagenicit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37d7de54f6e8c31bf7e6ada6ce58bab7
https://pubmed.ncbi.nlm.nih.gov/32057133
https://pubmed.ncbi.nlm.nih.gov/32057133
Autor:
Kevin A. Ford, Jasleen K. Sodhi, Dolores Diaz, Melisa Masuda, Donna Dambach, Jason Halladay, Gregory A. Ryslik
Publikováno v:
Drug Metabolism Reviews. 47:291-319
Cytochrome P450 2D6 (CYP2D6) is a polymorphic enzyme responsible for metabolizing approximately 25% of all drugs. CYP2D6 is highly expressed in the brain and plays a role as the major CYP in the metabolism of numerous brain-penetrant drugs, including
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ec2e9c4b9473c8a3266d22cc3a032b82
https://doi.org/10.3109/03602532.2015.1047026
https://doi.org/10.3109/03602532.2015.1047026