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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

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

Download Full-text

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 ◽

Download Full-text

Role of exposure-response analysis to guide dose selection in pediatric drug development when extrapolating efficacy from adults

Inflammatory Bowel Diseases ◽

10.1097/00054725-201112002-00013 ◽

2011 ◽

Vol 17 ◽

pp. S5-S6 ◽

Author(s):

Nitin Mehrotra ◽

Christine Garnett ◽

Li Zhang ◽

Lanyan Fang ◽

Yow-Ming Wang ◽

...

Keyword(s):

Drug Development ◽

Response Analysis ◽

Pediatric Drug ◽

Dose Selection ◽

Pediatric Drug Development ◽

Exposure Response

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text