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Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates

Current pharmaceutical design, 2017-01, Vol.23 (38), p.5801-5804

2017

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Regulatory science needs for neonates: a call for neonatal community collaboration and innovation

Frontiers in pediatrics, 2014-12, Vol.2, p.135-135

2014

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Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine

JAMA ophthalmology, 2021-02, Vol.139 (2), p.214

2021

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Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals

Clinical pharmacology and therapeutics, 2021-10, Vol.110 (4), p.997-1003

2021

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Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

Clinical pharmacology and therapeutics, 2020-11, Vol.108 (5), p.1018-1025

2020

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Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology

Clinical pharmacology and therapeutics, 2020-04, Vol.107 (4), p.707-709

2020

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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

Clinical pharmacology and therapeutics, 2018-11, Vol.104 (5), p.983-988

2018

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Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

Clinical pharmacology and therapeutics, 2019-03, Vol.105 (3), p.555-557

2019

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Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

Journal of clinical pharmacology, 2018-07, Vol.58 (7), p.885-890

2018

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Hypothalamic–Pituitary–Adrenal Axis Pediatric Safety Studies Submitted to the FDA

Therapeutic innovation & regulatory science, 2021-05, Vol.55 (3), p.622-630

2021

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Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014

Therapeutic innovation & regulatory science, 2015-09, Vol.49 (5), p.623-631

2015

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Vasoactive intestinal peptide in the brain of a mouse model for Down syndrome

Experimental neurology, 2003-09, Vol.183 (1), p.56-65

2003

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Pulmonary vascular balance in congenital diaphragmatic hernia: Enhanced endothelin-1 gene expression as a possible cause of pulmonary vasoconstriction

Journal of pediatric surgery, 1998, Vol.33 (1), p.81-84

1998

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Vasoactive intestinal peptide regulation of nerve growth factor in the embryonic mouse

Peptides (New York, N.Y. : 1980), 2002-10, Vol.23 (10), p.1803-1808

2002

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Maternal Regulation of Embryonic Growth: The Role of Vasoactive Intestinal Peptide

Endocrinology (Philadelphia), 1999-02, Vol.140 (2), p.917-924

1999

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Alpha-2A adrenergic receptor subtype gene expression in the intestines of cocaine-exposed rat embryos

Pediatric research, 2002-10, Vol.52 (4), p.504-508

2002

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Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels

Drug information journal, 2006-04, Vol.40 (2), p.185-195

2006

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Melatonin synthesis: analysis of the more than 150-fold nocturnal increase in serotonin N-acetyltransferase messenger ribonucleic acid in the rat pineal gland

Endocrinology (Philadelphia), 1996-07, Vol.137 (7), p.3033-3045

1996

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Erratum to: Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels

Drug information journal, 2006-07, Vol.40 (3), p.272-272

2006

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Sites of gene expression for vasoactive intestinal polypeptide throughout the brain of the chick (Gallus domesticus)

Journal of comparative neurology (1911), 1997-04, Vol.381 (1), p.101-118

1997

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Distribution of VIP mRNA and two distinct VIP binding sites in the developing rat brain: Relation to ontogenic events

Journal of comparative neurology (1911), 1994-04, Vol.342 (2), p.186-205

1994

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Maternal vasoactive intestinal peptide and the regulation of embryonic growth in the rodent

The Journal of clinical investigation, 1996-01, Vol.97 (1), p.202-208

1996

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Alpha-2A Adrenergic Receptor Gene Expression in the Embryonic Rat Intestine after Low and High Dose Cocaine Exposure In Utero

Pediatric research, 1999-04, Vol.45 (4, Part 2 of 2), p.232-232A

1999

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Alpha-2 Adrenergic Receptor Expression in the Intestine of Neonatal Rats Exposed In Utero to Cocaine † 341

Pediatric research, 1998-04, Vol.43, p.61-61

1998

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ADRENERGIC RECEPTOR mRNA EXPRESSION IN NEONATAL RATS WITH CONGENITAL DIAPHRAGMATIC HERNIA. † 2023

Pediatric research, 1996-04, Vol.39, p.340-340

1996

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Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates

Regulatory science needs for neonates: a call for neonatal community collaboration and innovation

Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine

Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

Hypothalamic–Pituitary–Adrenal Axis Pediatric Safety Studies Submitted to the FDA

Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014

Vasoactive intestinal peptide in the brain of a mouse model for Down syndrome

Pulmonary vascular balance in congenital diaphragmatic hernia: Enhanced endothelin-1 gene expression as a possible cause of pulmonary vasoconstriction

Vasoactive intestinal peptide regulation of nerve growth factor in the embryonic mouse

Maternal Regulation of Embryonic Growth: The Role of Vasoactive Intestinal Peptide

Alpha-2A adrenergic receptor subtype gene expression in the intestines of cocaine-exposed rat embryos

Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels

Melatonin synthesis: analysis of the more than 150-fold nocturnal increase in serotonin N-acetyltransferase messenger ribonucleic acid in the rat pineal gland

Erratum to: Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels

Sites of gene expression for vasoactive intestinal polypeptide throughout the brain of the chick (Gallus domesticus)

Distribution of VIP mRNA and two distinct VIP binding sites in the developing rat brain: Relation to ontogenic events

Maternal vasoactive intestinal peptide and the regulation of embryonic growth in the rodent

Alpha-2A Adrenergic Receptor Gene Expression in the Embryonic Rat Intestine after Low and High Dose Cocaine Exposure In Utero

Alpha-2 Adrenergic Receptor Expression in the Intestine of Neonatal Rats Exposed In Utero to Cocaine † 341

ADRENERGIC RECEPTOR mRNA EXPRESSION IN NEONATAL RATS WITH CONGENITAL DIAPHRAGMATIC HERNIA. † 2023

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