| Authors: |
Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States., Moody R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Rege B; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Pepin X; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden., Mitra A; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States., Suarez-Sharp S; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Borges LN; ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil., Kijima S; Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Malamatari M; Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States. |
