Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates
McCune, Susan K, Mulugeta, Yeruk Ager, Baer, Gerri R
Published in Current pharmaceutical design (01.01.2017)
Published in Current pharmaceutical design (01.01.2017)
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Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018
Tanaudommongkon, Irin, John Miyagi, Shogo, Green, Dionna J, Burnham, Janelle M, van den Anker, John N, Park, Kyunghun, Wu, Johanna, McCune, Susan K, Yao, Lynne, Burckart, Gilbert J
Published in Clinical pharmacology and therapeutics (01.11.2020)
Published in Clinical pharmacology and therapeutics (01.11.2020)
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Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology
Burckart, Gilbert J, Seo, Shirley, Pawlyk, Aaron C, McCune, Susan K, Yao, Lynne P, Giacoia, George P, Wang, Yaning, Zineh, Issam
Published in Clinical pharmacology and therapeutics (01.04.2020)
Published in Clinical pharmacology and therapeutics (01.04.2020)
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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
Green, Dionna J, Liu, Xiaomei I, Hua, Tianyi, Burnham, Janelle M, Schuck, Robert, Pacanowski, Michael, Yao, Lynne, McCune, Susan K, Burckart, Gilbert J, Zineh, Issam
Published in Clinical pharmacology and therapeutics (01.11.2018)
Published in Clinical pharmacology and therapeutics (01.11.2018)
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Journal Article
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA
Green, Dionna J, Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I, van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K, Burckart, Gilbert J
Published in Clinical pharmacology and therapeutics (01.03.2019)
Published in Clinical pharmacology and therapeutics (01.03.2019)
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Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA
Green, Dionna J, Burnham, Janelle M, Schuette, Paul, Liu, Xiaomei I, Maas, Brian M, Yao, Lynne, McCune, Susan K, Chen, Joseph, van den Anker, John N, Burckart, Gilbert J
Published in Journal of clinical pharmacology (01.07.2018)
Published in Journal of clinical pharmacology (01.07.2018)
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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
Offringa, Martin, Davis, Jonathan M., Turner, Mark A., Ward, Robert, Bax, Ralph, Maldonado, Sam, Sinha, Vikram, McCune, Susan K., Zajicek, Anne, Benjamin, Daniel K., Bucci-Rechtweg, Christina, Nelson, Robert M.
Published in Therapeutic innovation & regulatory science (01.09.2015)
Published in Therapeutic innovation & regulatory science (01.09.2015)
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Vasoactive intestinal peptide in the brain of a mouse model for Down syndrome
HILL, Joanna M, ADES, Anne M, MCCUNE, Susan K, SAHIR, Nadia, MOODY, Elizabeth M, ABEBE, Daniel T, CRNIC, Linda S, BRENNEMAN, Douglas E
Published in Experimental neurology (01.09.2003)
Published in Experimental neurology (01.09.2003)
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Vasoactive intestinal peptide regulation of nerve growth factor in the embryonic mouse
Hill, Joanna M, Mehnert, Janice, McCune, Susan K, Brenneman, Douglas E
Published in Peptides (New York, N.Y. : 1980) (01.10.2002)
Published in Peptides (New York, N.Y. : 1980) (01.10.2002)
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Maternal Regulation of Embryonic Growth: The Role of Vasoactive Intestinal Peptide
Spong, Catherine Y., Lee, Susan J., McCune, Susan K., Gibney, Gretchen, Abebe, Daniel T., Alvero, Ruben, Brenneman, Douglas E., Hill, Joanna M.
Published in Endocrinology (Philadelphia) (01.02.1999)
Published in Endocrinology (Philadelphia) (01.02.1999)
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Pulmonary vascular balance in congenital diaphragmatic hernia: Enhanced endothelin-1 gene expression as a possible cause of pulmonary vasoconstriction
Okazaki, Tadaharu, Sharma, Hari S, McCune, Susan K, Tibboel, Dick
Published in Journal of pediatric surgery (1998)
Published in Journal of pediatric surgery (1998)
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Conference Proceeding
Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels
McCune, Susan K., Mathis, Lisa L., Cocchetto, David M., Ball, Karen, Rodriguez, W.
Published in Drug information journal (01.04.2006)
Published in Drug information journal (01.04.2006)
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Erratum to: Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels
McCune, Susan K., Mathis, Lisa L., Cocchetto, David M., Ball, Karen, Rodriguez, W.
Published in Drug information journal (01.07.2006)
Published in Drug information journal (01.07.2006)
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Journal Article
Melatonin synthesis: analysis of the more than 150-fold nocturnal increase in serotonin N-acetyltransferase messenger ribonucleic acid in the rat pineal gland
Roseboom, P H, Coon, S L, Baler, R, McCune, S K, Weller, J L, Klein, D C
Published in Endocrinology (Philadelphia) (01.07.1996)
Published in Endocrinology (Philadelphia) (01.07.1996)
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