About the Authors

Rodney Rouse

rodney.rouse@fda.hhs.gov

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Leshuai Zhang

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Katherine Shea

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Hongfei Zhou

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Lin Xu

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Sharron Stewart

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Barry Rosenzweig

Affiliation Division of Applied Regulatory Science, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Jun Zhang

Affiliation Division of Applied Regulatory Science, Center for Drug 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.

Author Contributions

Conceived and designed the experiments: RR LZ SS BR. Performed the experiments: RR LZ KS LX SS BR. Analyzed the data: RR KS HZ JZ. Contributed to the writing of the manuscript: RR LZ KS HZ LX SS BR JZ.