Exposure–Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration-Reference-Cited by-同舟云学术

Exposure–Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration

Published:2020-03-16 Issue:1 Volume:108 Page:90-98
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Zhang Yifei¹,Wang Yaning²,Khurana Mona³,Sachs Hari Cheryl³,Zhu Hao²,Burckart Gilbert J.²,Alexander John¹,Yao Lynne P.³,Wang Jian¹

Affiliation:

1. Office of Drug Evaluation IV Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland, USA

2. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland, USA

3. Division of Pediatric and Maternal Health Office of Drug Evaluation IV Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland, USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1809

Reference33 articles.

1. Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

2. Exposure– and Dose–response Analyses in Dose Selection and Labeling of FDA-approved Biologics

3. US Food and Drug Administration.Guidance for industry: exposure‐response relationships—study design data analysis and regulatory applications (2003). Accessed September 12 2019.

4. FDA‐NIH Biomarker Working Group.BEST (Biomarkers EndpointS and other Tools) Resource (2017).

5. US Food and Drug Administration.Guidance for industry: general clinical pharmacology considerations for neonatal studies for drugs and biological products (2019). Accessed September 12 2019.

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