Harmonized 3Rs-based non-mutagenic impurity qualification study designs developed using the results of an IQ consortium survey
Mayur S. Mitra(GenVec), Joel P. Bercu(Eli Lilly (United States)), Teresa C. Wegesser(Amgen (United States)), John Nicolette(AbbVie (United States)), Richard W. Hutchinson(Janssen (United States)), Kaushik Datta(Bristol-Myers Squibb (Germany)), John C. Pettersen(Vertex Pharmaceuticals (United States))
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