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 ◽

Author(s):

Dionna J. Green ◽

Xiaomei I. Liu ◽

Tianyi Hua ◽

Janelle M. Burnham ◽

Robert Schuck ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

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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 ◽

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

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1809 ◽

2020 ◽

Vol 108 (1) ◽

pp. 90-98 ◽

Author(s):

Yifei Zhang ◽

Yaning Wang ◽

Mona Khurana ◽

Hari Cheryl Sachs ◽

Hao Zhu ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Response Assessment ◽

Development Studies ◽

Pediatric Drug ◽

Pediatric Drug Development ◽

Exposure Response ◽

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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 ◽

2021 ◽

Vol 61 (S1) ◽

Author(s):

Clara Kim ◽

Kyunghun Park ◽

Ann W. McMahon ◽

Francis G. Green ◽

Dionna J. Green ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Drug Safety ◽

Food And Drug Administration ◽

Pediatric Drug ◽

Dose Selection ◽

Pediatric Drug Development ◽

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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 ◽

Richard Pazdur

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Cancer Drug ◽

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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 ◽

Vol 1 (10) ◽

pp. 1345-1347 ◽

Author(s):

Lisa Mathis ◽

Hong Vu ◽

Andrew E Mulberg

Keyword(s):

Drug Development ◽

Pediatric Drug ◽

Medical Needs ◽

Pediatric Drug Development ◽

The Us ◽

Us Fda ◽

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 ◽

Vol 5 (4) ◽

pp. 338-343

Author(s):

Gerald J. Dal Pan

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

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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 ◽

Drug Administration ◽

Food And Drug Administration ◽

Cancer Drug ◽

Drug Registration ◽

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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):

Major Depressive Disorder ◽

Depressive Disorder ◽

Drug Administration ◽

Food And Drug Administration ◽

Major Depressive ◽

Efficacy Data ◽

New Drug ◽

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Cardiovascular and Renal Advisory Panel of the US Food and Drug Administration Considers Four Drugs

Circulation ◽

10.1161/01.cir.95.10.2335 ◽

1997 ◽

Vol 95 (10) ◽

pp. 2335-2335 ◽

Author(s):

Dan M. Roden

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Advisory Panel ◽

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Erratum to “Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration”

Cancer ◽

10.1002/cncr.33544 ◽

2021 ◽

Keyword(s):

Drug Administration ◽

Clinical Benefit ◽

Food And Drug Administration ◽

Cancer Drugs ◽

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