Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development-Reference-Cited by-同舟云学术

Renal Clearance in Newborns and Infants: Predictive Performance of Population‐Based Modeling for Drug Development

Published:2019-02-10 Issue:6 Volume:105 Page:1462-1470
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Wang Jian¹,Kumar Shaun S.²,Sherwin Catherine M.²,Ward Robert²,Baer Gerri³,Burckart Gilbert J.⁴,Wang Yaning⁴,Yao Lynne P.⁵

Affiliation:

1. Office of Drug Evaluation IVCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

2. Department of PediatricsDivision of Clinical PharmacologyUniversity of Utah School of Medicine Salt Lake City Utah USA

3. Office of Pediatric TherapeuticsUS Food and Drug Administration Silver Spring Maryland USA

4. Office of Clinical PharmacologyCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

5. Division of Pediatric and Maternal HealthOffice of Drug Evaluation IVCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1332

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3. US Food and Drug Administration.Draft guidance for industry: general clinical pharmacology considerations for pediatric studies for drugs and biological products. . Accessed January 27 2015.

4. Pharmacometric Approaches to Personalize Use of Primarily Renally Eliminated Antibiotics in Preterm and Term Neonates

5. Prediction of the Clearance of Eleven Drugs and Associated Variability in Neonates, Infants and Children

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