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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
dc.contributor.authorGreen, Dionna J.
dc.contributor.authorLiu, Xiaomei I.
dc.contributor.authorHua, Tianyi
dc.contributor.authorBurnham, Janelle M.
dc.contributor.authorSchuck, Robert
dc.contributor.authorPacanowski, Michael
dc.contributor.authorYao, Lynne
dc.contributor.authorMcCune, Susan K.
dc.contributor.authorBurckart, Gilbert J.
dc.contributor.authorZineh, Issam
dc.date.accessioned2018-11-20T15:32:26Z
dc.date.available2020-01-06T16:40:59Zen
dc.date.issued2018-11
dc.identifier.citationGreen, Dionna J.; Liu, Xiaomei I.; Hua, Tianyi; Burnham, Janelle M.; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K.; Burckart, Gilbert J.; Zineh, Issam (2018). "Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration." Clinical Pharmacology & Therapeutics 104(5): 983-988.
dc.identifier.issn0009-9236
dc.identifier.issn1532-6535
dc.identifier.urihttps://hdl.handle.net/2027.42/146322
dc.publisherWiley Periodicals, Inc.
dc.publisherUS Food and Drug Administration
dc.titleEnrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration
dc.typeArticleen_US
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelPharmacy and Pharmacology
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/146322/1/cpt971_am.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/146322/2/cpt971.pdf
dc.identifier.doi10.1002/cpt.971
dc.identifier.sourceClinical Pharmacology & Therapeutics
dc.identifier.citedreferenceMomper J.D. et al. Drug development for pediatric neurogenic bladder dysfunction: dosing, endpoints, and study design. J. Clin. Pharmacol. 54, 1239 – 1246 ( 2014 ).
dc.identifier.citedreferenceSun H. et al. Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents. JAMA Pediatr. 167, 243 – 249 ( 2013 ).
dc.identifier.citedreferenceDrugs@FDA: FDA Approved Drug Products. Available from: < https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm >
dc.identifier.citedreferenceReviews of Pediatric Studies Conducted under BPCA and PREA from 2012–present. Available from: < https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm316937.htm >
dc.identifier.citedreferenceReviews of Pediatric Studies Conducted under BPCA and PREA from 2007‐2012. Available from: < https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm >
dc.identifier.citedreferenceTemple R. Early escape, enrichment, studies in non‐responders. Commun. Stat. Theory Methods 23, 499 – 531 ( 1994 ).
dc.identifier.citedreferenceTemple R. Enrichment of clinical study populations. Clin. Pharmacol. Ther. 88, 774 – 778 ( 2010 ).
dc.identifier.citedreferenceGuidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. Silver Spring, MD: US Food and Drug Administration; 2012.
dc.identifier.citedreferenceWharton G.T. et al. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy. Pediatrics 134, e512 – 518 ( 2014 ).
dc.identifier.citedreferenceMomper J.D., Mulugeta Y. & Burckart G.J. Failed pediatric drug development trials. Clin. Pharmacol. Ther. 98, 245 – 251 ( 2015 ).
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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