Bridging Adult Experience to Pediatrics in Oncology Drug Development-Reference-Cited by-同舟云学术

Bridging Adult Experience to Pediatrics in Oncology Drug Development

Published:2017-09-15 Issue: Volume:57 Page:S129-S135
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Leong Ruby¹,Zhao Hong¹,Reaman Gregory²,Liu Qi¹,Wang Yaning¹,Stewart Clinton F.³,Burckart Gilbert¹

Affiliation:

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

2. Office of Hematology and Oncology Products; Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Spring MD, USA

3. Department of Pharmaceutical Sciences; St. Jude Children's Research Hospital; Memphis TN, USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference42 articles.

1. US Food and Drug Administration http://www.fda.gov/ohrms/dockets/98fr/120298c.txt

2. Pediatric Research Equity Act https://www.gpo.gov/fdsys/pkg/STATUTE-117/pdf/STATUTE-117-Pg1936.pdf

3. US Food and Drug Administration http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079756.pdf

4. Food and Drug Administration Modernization Act of 1997 https://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf

5. Pediatric studies of drugs https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355a.pdf

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