Zobrazeno 1 - 2
of 2
pro vyhledávání: '"Eric Dowdy"'
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:
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