About the Authors

Xiaoxia Yang

xiaoxia.yang@fda.hhs.gov

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Suzanne M. Morris

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Jeffery M. Gearhart

Affiliation The Henry M. Jackson Foundation for the Advancement of Military Medicine, Wright-Patterson Air Force Base, Ohio, United States of America

Christopher D. Ruark

Affiliation The Henry M. Jackson Foundation for the Advancement of Military Medicine, Wright-Patterson Air Force Base, Ohio, United States of America

Merle G. Paule

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

William Slikker Jr

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Donald R. Mattison

Affiliations Risk Sciences International, Ottawa, Ontario, Canada, University of Ottawa, Ottawa, Ontario, Canada

Benedetto Vitiello

Affiliation National Institute of Mental Health, Bethesda, Maryland, United States of America

Nathan C. Twaddle

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Daniel R. Doerge

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

John F. Young

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Jeffrey W. Fisher

Affiliation National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas, United States of America

Competing Interests

Dr. Donald R. Mattison has worked as a consulting expert in litigation against other pharmaceutical companies brought by government entities and private plaintiffs. Dr. Mattison is an officer of Risk Sciences International, a firm whose clients include Health Canada and the FDA. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Author Contributions

Conceived and designed the experiments: SM MP WS DM BV. Performed the experiments: SM MP WS DM BV NT DD. Analyzed the data: XY JF JY. Contributed reagents/materials/analysis tools: SM MP WS DM BV NT DD. Wrote the paper: XY JF. Oversaw the day-to-day conduct of the monkey study: SM. Derived the partition coefficents for the PBPK model: JG CR. Revised the manuscript critically for important intellectual content: SM JG CR MP WS DM BV NT DD JY.