Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals

Stephen Horne, Matthew D. Vera, Laxma R. Nagavelli, Vilayat A. Sayeed, Laurel M. Heckman, Deborah G. Johnson, Dan Berger, Yean Yean Yip, Carolina L. Krahn, Letícia Oyamada Sizukusa, Nayrton Flávio Moura Rocha, Robert N. Bream, Joachim Ludwig, David A. Keire, Gary Condran