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Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007–2020
The Journal of Clinical Pharmacology
◽
10.1002/jcph.1973
◽
2021
◽
Author(s):
Kyunghun Park
◽
Kristina Vishnevetskaya
◽
Jayabharathi Vaidyanathan
◽
Gilbert J. Burckart
◽
Dionna J. Green
Keyword(s):
Drug Development
◽
Familial Hypercholesterolemia
◽
Drug Administration
◽
Food And Drug Administration
◽
Development Studies
◽
Pediatric Drug
◽
Pediatric Drug Development
◽
The Us
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Exposure–Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration
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10.1002/cpt.1809
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Vol 108
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Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration
The Journal of Clinical Pharmacology
◽
10.1002/jcph.1864
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2021
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◽
Author(s):
Clara Kim
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Kyunghun Park
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Ann W. McMahon
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Francis G. Green
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Drug Safety
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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
Clinical Pharmacology & Therapeutics
◽
10.1002/cpt.971
◽
2018
◽
Vol 104
(5)
◽
pp. 983-988
◽
Cited By ~ 2
Author(s):
Dionna J. Green
◽
Xiaomei I. Liu
◽
Tianyi Hua
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Robert Schuck
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Food And Drug Administration
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Role of the US Food and Drug Administration in Cancer Drug Development
Principles of Anticancer Drug Development
◽
10.1007/978-1-4419-7358-0_12
◽
2010
◽
pp. 305-332
Author(s):
Ann T. Farrell
◽
Ramzi N. Dagher
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Richard Pazdur
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Drug Development
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Food And Drug Administration
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Pediatric drug development: unmet medical needs and opportunities for collaboration between industry, academia and the US FDA
Clinical Investigation
◽
10.4155/cli.11.118
◽
2011
◽
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pp. 1345-1347
◽
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Author(s):
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◽
Hong Vu
◽
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◽
Pediatric Drug
◽
Medical Needs
◽
Pediatric Drug Development
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◽
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Unmet Medical Needs
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The US Food and Drug Administration, neurologists, and drug development and regulation
Neurology Clinical Practice
◽
10.1212/cpj.0000000000000153
◽
2015
◽
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◽
pp. 338-343
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Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration
Yearbook of Medicine
◽
10.1016/s0084-3873(08)70434-6
◽
2006
◽
Vol 2006
◽
pp. 193-194
Author(s):
P.J. Loehrer
Keyword(s):
Clinical Trials
◽
Elderly Patients
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Drug Administration
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Cancer Drug
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Faculty Opinions recommendation of Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications.
Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature
◽
10.3410/f.11069957.12022055
◽
2011
◽
Author(s):
Malcolm Lader
Keyword(s):
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Efficacy Data
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Cardiovascular and Renal Advisory Panel of the US Food and Drug Administration Considers Four Drugs
Circulation
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10.1161/01.cir.95.10.2335
◽
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Erratum to “Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration”
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10.1002/cncr.33544
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Keyword(s):
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