Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses()

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 mutagenicity data, (Q)SAR analysis may be used as a test to...

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Udgivet i:Regul Toxicol Pharmacol
Main Authors: Amberg, Alexander, Andaya, Roxanne V., Anger, Lennart T., Barber, Chris, Beilke, Lisa, Bercu, Joel, Bower, Dave, Brigo, Alessandro, Cammerer, Zoryanna, Cross, Kevin P., Custer, Laura, Dobo, Krista, Gerets, Helga, Gervais, Véronique, Glowienke, Susanne, Gomez, Stephen, Van Gompel, Jacky, Harvey, James, Hasselgren, Catrin, Honma, Masamitsu, Johnson, Candice, Jolly, Robert, Kemper, Raymond, Kenyon, Michelle, Kruhlak, Naomi, Leavitt, Penny, Miller, Scott, Muster, Wolfgang, Naven, Russell, Nicolette, John, Parenty, Alexis, Powley, Mark, Quigley, Donald P., Reddy, M. Vijayaraj, Sasaki, Jennifer C., Stavitskaya, Lidiya, Teasdale, Andrew, Trejo-Martin, Alejandra, Weiner, Sandy, Welch, Dennie S., White, Angela, Wichard, Joerg, Woolley, David, Myatt, Glenn J.
Format: Artigo
Sprog:Inglês
Udgivet: 2018
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Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7500704/
https://ncbi.nlm.nih.gov/pubmed/30562600
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.yrtph.2018.12.007
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