Zobrazeno 1 - 10
of 30
pro vyhledávání: '"John Nicolette"'
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:
Sheroy Minocherhomji, George E. Johnson, Véronique Thybaud, B. Bhaskar Gollapudi, Krista L. Dobo, James Harvey, Julia Kenny, Andreas Zeller, Michelle O. Kenyon, Ryan P Wheeldon, John Nicolette, Anthony M. Lynch
Publikováno v:
Environmental and Molecular Mutagenesis. 62:293-305
A genotoxic carcinogen, N-nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs in 2018, and other N-nitrosamines, such as N-nitrosodiethylamine (NDEA), were later detected in other sartan products. N-nitrosamines
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b609d720dd59c323257a79208045cc8a
https://doi.org/10.1002/em.22446
https://doi.org/10.1002/em.22446
Autor:
Jessica C. Graham, Alejandra Trejo-Martin, Martyn L. Chilton, Jakub Kostal, Joel Bercu, Gregory L. Beutner, Uma S. Bruen, David G. Dolan, Stephen Gomez, Jedd Hillegass, John Nicolette, Matthew Schmitz
Publikováno v:
Chemical research in toxicology. 35(6)
Peptide couplers (also known as amide bond-forming reagents or coupling reagents) are broadly used in organic chemical syntheses, especially in the pharmaceutical industry. Yet, occupational health hazards associated with this chemical class are larg
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::83ea18af40f3631f3592327aa4d47482
https://pubmed.ncbi.nlm.nih.gov/35532537
https://pubmed.ncbi.nlm.nih.gov/35532537
Publikováno v:
Environmental and Molecular Mutagenesis. 62:4-17
Hydrazine has been described as a mutagenic, probable human carcinogen. It is mutagenic in in vitro systems such as bacterial reverse mutation (Ames) tests and some yeast systems, as well as in in vivo systems with drosophila. It was shown to cause c
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8a94467341eac707fef7b1012b723a11
https://doi.org/10.1002/em.22406
https://doi.org/10.1002/em.22406
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
A cross-industry survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10
Autor:
Laure Delafoy, Helga Gerets, Betty Pettersen, Douglas C. Bauer, Jonathan Howe, Heidrun Ellinger-Ziegelbauer, John Nicolette, Lorrene A. Buckley, Brian Schimpf, Gerry Kaijser, Mick D. Fellows
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 125
A cross-industry survey was conducted by EFPIA/IQ DruSafe in 2018 to provide information on photosafety evaluation of pharmaceuticals after implementation of ICH S10. This survey focused on the strategy utilized for photosafety risk assessment, the d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5f027468b0b535ab9526b88c4eb56f4
https://pubmed.ncbi.nlm.nih.gov/34311056
https://pubmed.ncbi.nlm.nih.gov/34311056
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:
Joel P. Bercu, Zhanna Sobol, John Nicolette, Patricia Parris, William C. Drewe, Krista L. Dobo
Publikováno v:
International journal of toxicology. 40(3)
A workshop entitled “Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis” was held at the 2018 Genetic Toxicology Association annual meeting. The objectives of the workshop were to provide an educational foru
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::44e9ba88ebc1875fc351b471c66b8606
https://pubmed.ncbi.nlm.nih.gov/33525949
https://pubmed.ncbi.nlm.nih.gov/33525949
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:
Joel P. Bercu, Richard Hutchinson, Kaushik Datta, John C. Pettersen, John Nicolette, Teresa C. Wegesser, Mayur S. Mitra
Publikováno v:
Regulatory Toxicology and Pharmacology. 122:104895
As per the ICH Q3A(R2) and Q3B(R2) regulatory guidelines, safety studies may be needed when an impurity in new drug substances or products is above the qualification threshold, and such qualification studies should be conducted in one nonclinical spe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4f58ccaac1578797cdabf73cd17ec62
https://doi.org/10.1016/j.yrtph.2021.104895
https://doi.org/10.1016/j.yrtph.2021.104895