Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Author:

Bi Youwei1,Liu Jiang1,Li Lingjue1,Yu Jingyu1,Bhattaram Atul1,Bewernitz Michael1,Li Ruo‐jing1,Liu Chao1,Earp Justin1,Ma Lian1,Zhuang Luning1,Yang Yuching1,Zhang Xinyuan1,Zhu Hao1,Wang Yaning1

Affiliation:

1. Food and Drug Administration Silver Spring MD USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference39 articles.

1. US Food and Drug Administration (FDA).Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. Status report to Congress.https://www.fda.gov/media/99184/download. Accessed July 1 2016.

2. US Food and Drug Administration (FDA).How to comply with the Pediatric Research Equity Act.https://www.fda.gov/media/72274/download. Accessed September 1 2005.

3. Pediatric Information in Drug Product Labeling

4. Lynne P.Yao. Pediatric drug development: moving toward the best pharmaceuticals for children. Pediatric Drug Development Workshop. March 24 2017. American Course on Drug Development and Regulatory Sciences.

5. Failed Pediatric Drug Development Trials

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