About the Authors
- Christopher R. Ellis
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Roles Conceptualization, Funding acquisition, Software, Supervision, Writing – review & editing
* E-mail: 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.