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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