Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure

Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure–Response

Published:2022-09-11 Issue:1 Volume:63 Page:105-118
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Balevic Stephen J.¹²,Niu Jing³,Chen Jianmeng³,Green Dionna⁴,McMahon Ann⁴,Hornik Christoph P.¹,Schanberg Laura E.¹²,Glaser Rachel⁵,Gonzalez Daniel⁶,Burckart Gilbert J.³

Affiliation:

1. Duke Clinical Research Institute Durham North Carolina USA

2. Department of Pediatrics Duke University Durham North Carolina USA

3. Office of Clinical Pharmacology Center for Drug Evaluation and Research (CDER) United States Food and Drug Administration (FDA) Silver Spring Maryland USA

4. Office of Pediatric Therapeutics Office of the Commissioner United States Food and Drug Administration (FDA) Silver Spring Maryland USA

5. Division of Rheumatology and Transplant Medicine Office of Immunology and Inflammation Office of New Drugs CDER, FDA Silver Spring Maryland USA

6. Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2139

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4. United States Food and Drug Administration (FDA).Pediatric science and research activities. FDA web site.https://www.fda.gov/science‐research/pediatrics/pediatric‐science‐and‐research‐activities. Updated October 15 2021. Accessed October 25 2021.

5. United States Food and Drug Administration (FDA).Guidance document: general clinical pharmacology considerations for pediatric studies for drugs and biological products. December2014. FDA web site.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425885.pdf. Accessed October 25 2021.

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