About the Authors

Christopher R. Ellis

Roles Data curation, Formal analysis, Methodology, Writing – original draft

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Rebecca Racz

Roles Formal analysis, Methodology, Software, Writing – original draft

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Naomi L. Kruhlak

Roles Conceptualization, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Marlene T. Kim

Roles Data curation, Formal analysis, Methodology, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Alexey V. Zakharov

Roles Funding acquisition, Resources, Writing – review & editing

Affiliation National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, United States of America

Noel Southall

Roles Funding acquisition, Resources, Writing – review & editing

Affiliation National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, United States of America

Edward G. Hawkins

Roles Conceptualization, Writing – review & editing

Affiliation Controlled Substances Staff, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Keith Burkhart

Roles Software, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

David G. Strauss

Roles Conceptualization, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Lidiya Stavitskaya

Roles Conceptualization, Funding acquisition, Software, Supervision, Writing – review & editing

Lidiya.Stavitskaya@fda.hhs.gov

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, United States of America

Competing Interests

This work was performed as part of a Research Collaboration Agreement between the FDA and Chemotargets SL, Barcelona, Spain. The findings and conclusions in this article reflect the views of the authors and should not be construed to represent the FDA's views or policies. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.