A review of the experience with pediatric written requests issued for oncology drug products-Reference-Cited by-同舟云学术

A review of the experience with pediatric written requests issued for oncology drug products

Published:2020-11-27 Issue:2 Volume:68 Page:
ISSN:1545-5009
Container-title:Pediatric Blood & Cancer
language:en
Short-container-title:Pediatr Blood Cancer

Author:

Akalu Alemayehu Y.¹,Meng Xi²,Reaman Gregory H.¹³,Ma Lian⁴,Yuan Weishi⁵,Ye Jingjing⁵^ORCID

Affiliation:

1. Office of Oncologic Diseases Office of New Drugs Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Silver Spring Maryland

2. Department of Biostatistics School of Public Health and Health Sciences University of Massachusetts Amherst Massachusetts

3. Oncology Center of Excellence (OCE) U.S. Food and Drug Administration (FDA) Silver Spring Maryland

4. Division of Pharmacometrics (DPM) Office of Clinical Pharmacology (OCP) Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Silver Spring Maryland

5. Division of Biostatistics IX (DBIX) Office of Biostatistics (OB) Office of Translational Sciences (OTS) Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration (FDA) Silver Spring Maryland

Publisher

Wiley

Subject

Oncology,Hematology,Pediatrics, Perinatology, and Child Health

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pbc.28828

Reference38 articles.

1. Editorial comment: Therapeutic orphans

2. Institute of Medicine (US) Forum on Drug Discovery Development and Translation.Pediatric Research Equity Act (PREA).https://www.ncbi.nlm.nih.gov/books/NBK3997/. Accessed November 19 2020.

3. NIH.Best Pharmaceuticals for Children's Act (BPCA).https://bpca.nichd.nih.gov/Pages/default.aspx. Accessed November 19 2020.

4. FDA.Yondelis. United States prescribing information (USPI).https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf. Accessed November 19 2020.

Cited by 17 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress;Cold Spring Harbor Perspectives in Medicine;2024-03-11

2. Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests;JAMA Oncology;2024-03-01

3. Clinical development of new drugs for adults and children with cancer, 2010-2020;JNCI: Journal of the National Cancer Institute;2023-05-12

4. Evidence of clinical benefit of WHO essential anticancer medicines for children, 2011–2021;eClinicalMedicine;2023-05

5. Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US;Journal of Biopharmaceutical Statistics;2023-02-07