| Authors: |
Zaker Y; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States., Yilmaz H; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States., Lex TR; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States., Guo C; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States., Rodriguez JD; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States., Willett DR; Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States. Electronic address: daniel.willett@fda.hhs.gov. |