Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007–2020

Development Studies ◽

Pediatric Drug ◽

The Us

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 ◽

Cited By ~ 2

Author(s):

Yifei Zhang ◽

Yaning Wang ◽

Mona Khurana ◽

Hari Cheryl Sachs ◽

Hao Zhu ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Response Assessment ◽

Development Studies ◽

Pediatric Drug ◽

Exposure Response ◽

The Us

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 ◽

Pediatric Drug ◽

Dose Selection ◽

The Us

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 ◽

Janelle M. Burnham ◽

Robert Schuck ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Pediatric Drug ◽

The Us

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 ◽

Cancer Drug ◽

The Us

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 ◽

Cited By ~ 2

Author(s):

Lisa Mathis ◽

Hong Vu ◽

Andrew E Mulberg

Keyword(s):

Drug Development ◽

Pediatric Drug ◽

Medical Needs ◽

The Us ◽

Us Fda ◽

Unmet Medical Needs

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 ◽

The Us

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 ◽

Cancer Drug ◽

Drug Registration ◽

The Us

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 ◽

Major Depressive ◽

Efficacy Data ◽

New Drug ◽

The Us

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 ◽

Cited By ~ 10

Author(s):

Dan M. Roden

Keyword(s):

Drug Administration ◽

Advisory Panel ◽

The Us

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 ◽

Cancer Drugs ◽

The Us