About the Authors

Wencel Valega-Mackenzie

Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Visualization, Writing – original draft, Writing – review & editing

Affiliation Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Marisabel Rodriguez Messan

Roles Data curation, Investigation, Methodology, Validation, Writing – review & editing

Affiliation Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Osman N. Yogurtcu

Roles Validation, Writing – review & editing

Affiliation Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Ujwani Nukala

Roles Writing – review & editing

Affiliation Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Zuben E. Sauna

Roles Writing – review & editing

Affiliation Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Hong Yang

Roles Conceptualization, Funding acquisition, Project administration, Resources, Supervision, Writing – review & editing

Hong.Yang@fda.hhs.gov

Affiliation Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Competing Interests

The authors have declared that no competing interests exist.