About the Authors

Zhao-Hua Zhou

Roles Conceptualization, Formal analysis, Methodology, Writing – original draft, Writing – review & editing

Zhaohua.Zhou@fda.hhs.gov (ZZ); Steven.Kozlowski@fda.hhs.gov (SK)

Affiliation Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring, Maryland, United States of America

Sai Dharmarajan

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

Affiliation Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring, Maryland, United States of America

Mari Lehtimaki

Roles Formal analysis, Writing – review & editing

Affiliation Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring, Maryland, United States of America

Susan L. Kirshner

Roles Formal analysis, Writing – review & editing

Affiliation Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring, Maryland, United States of America

Steven Kozlowski

Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing

Zhaohua.Zhou@fda.hhs.gov (ZZ); Steven.Kozlowski@fda.hhs.gov (SK)

Affiliation Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring, Maryland, United States of America

Competing Interests

The authors have declared that no competing interests exist.