Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.

Authors

Dionna J. Green
Haihao Sun
Janelle Burnham
Xiaomei I. Liu
John van den Anker, George Washington University
Jean Temeck
Lynne Yao
Susan K. McCune
Gilbert J. Burckart

Document Type

Journal Article

Publication Date

3-1-2019

Journal

Clinical Pharmacology and Therapeutics

Volume

105

Issue

3

Inclusive Pages

555-557

DOI

10.1002/cpt.1117

Keywords

Biomarkers; Child; Clinical Trials as Topic; Drug Approval; Humans; United States; United States Food and Drug Administration

Comments

Epub 2018 Aug 9

APA Citation

Green, D. J., Sun, H., Burnham, J., Liu, X. I., van den Anker, J., Temeck, J., Yao, L., McCune, S. K., & Burckart, G. J. (2019). Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.. Clinical Pharmacology and Therapeutics, 105 (3). http://dx.doi.org/10.1002/cpt.1117

Peer Reviewed

1