A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
Müller, Lutz, Mauthe, Robert J., Riley, Christopher M., Andino, Marta M., Antonis, David De, Beels, Chris, DeGeorge, Joseph, De Knaep, Alfons G.M., Ellison, Dean, Fagerland, Jane A., Frank, Rebecca, Fritschel, Betsy, Galloway, Sheila, Harpur, Ernie, Humfrey, Charles D.N., Jacks, Alexander S., Jagota, Nirdosh, Mackinnon, John, Mohan, Ganapathy, Ness, Daniel K., O’Donovan, Michael R., Smith, Mark D., Vudathala, Gopi, Yotti, Larry
Published in Regulatory toxicology and pharmacology (01.04.2006)
Published in Regulatory toxicology and pharmacology (01.04.2006)
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Journal Article
Starting material, reprocessing retesting, and critical controls
Cupps, Tom, Betsy Fritschel Wendy Mavroudakis, Mitchell, Michael
Published in Pharmaceutical Technology (01.02.2003)
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Published in Pharmaceutical Technology (01.02.2003)
Trade Publication Article
PhRMA perspectives on drug substance regulatory filing issues: starting material, reprocessing, retesting, and critical controls
Cupps, Tom, Fritschel, Betsy, Mavroudakis, Wendy, Mitchell, Michael, Ridge, Dave, Wyvratt, Jean
Published in Pharmaceutical technology (2003) (01.02.2003)
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Published in Pharmaceutical technology (2003) (01.02.2003)
Magazine Article