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Innovation and Opportunities in Pediatric Therapeutic Development.

McCune S, Portman RJ.

Ther Innov Regul Sci. 2019 Sep;53(5):564-566. doi: 10.1177/2168479019869754. No abstract available.


Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.

West H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F.

Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20.


Role of Patients and Parents in Pediatric Drug Development.

Tsang VWL, West L, Woods C, Koh CJ, McCune S, Mullin T, Smith SR, Gaillard S, Claverol J, Nafria B, Preston J, Dicks P, Thompson C.

Ther Innov Regul Sci. 2019 Sep;53(5):601-608. doi: 10.1177/2168479018820875. Epub 2019 Jan 20.


Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.

Zimmerman KO, Smith PB, McMahon AW, Temeck J, Avant D, Murphy D, McCune S.

JAMA Pediatr. 2019 Jan 1;173(1):60-67. doi: 10.1001/jamapediatrics.2018.3227.


Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.

Green DJ, Sun H, Burnham J, Liu XI, van den Anker J, Temeck J, Yao L, McCune SK, Burckart GJ.

Clin Pharmacol Ther. 2019 Mar;105(3):555-557. doi: 10.1002/cpt.1117. Epub 2018 Aug 9.


Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.

Green DJ, Burnham JM, Schuette P, Liu XI, Maas BM, Yao L, McCune SK, Chen J, van den Anker JN, Burckart GJ.

J Clin Pharmacol. 2018 Jul;58(7):885-890. doi: 10.1002/jcph.1109. Epub 2018 Apr 17.


Social capital and pet ownership - A tale of four cities.

Wood L, Martin K, Christian H, Houghton S, Kawachi I, Vallesi S, McCune S.

SSM Popul Health. 2017 May 5;3:442-447. doi: 10.1016/j.ssmph.2017.05.002. eCollection 2017 Dec.


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

Green DJ, Liu XI, Hua T, Burnham JM, Schuck R, Pacanowski M, Yao L, McCune SK, Burckart GJ, Zineh I.

Clin Pharmacol Ther. 2018 Nov;104(5):983-988. doi: 10.1002/cpt.971. Epub 2018 Feb 13.


Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Mulugeta YL, Zajicek A, Barrett J, Sachs HC, McCune S, Sinha V, Yao L.

Pediatr Clin North Am. 2017 Dec;64(6):1185-1196. doi: 10.1016/j.pcl.2017.08.015. Review.


Collaboration in Regulatory Science to Facilitate Therapeutic Development for Neonates.

McCune SK, Mulugeta YA, Baer GR.

Curr Pharm Des. 2017;23(38):5801-5804. doi: 10.2174/1381612823666170926114857. Review.


The association between dog ownership or dog walking and fitness or weight status in childhood.

Westgarth C, Boddy LM, Stratton G, German AJ, Gaskell RM, Coyne KP, Bundred P, McCune S, Dawson S.

Pediatr Obes. 2017 Dec;12(6):e51-e56. doi: 10.1111/ijpo.12176. Epub 2016 Oct 28.


The association between dog walking, physical activity and owner's perceptions of safety: cross-sectional evidence from the US and Australia.

Christian H, Wood L, Nathan A, Kawachi I, Houghton S, Martin K, McCune S.

BMC Public Health. 2016 Sep 22;16(1):1010.


The International Neonatal Consortium: collaborating to advance regulatory science for neonates.

Turner MA, Davis JM, McCune S, Bax R, Portman RJ, Hudson LD.

Pediatr Res. 2016 Oct;80(4):462-4. doi: 10.1038/pr.2016.119. Epub 2016 Jun 8. No abstract available.


The interplay between genetic background and sexual dimorphism of doxorubicin-induced cardiotoxicity.

Zordoky BN, Radin MJ, Heller L, Tobias A, Matise I, Apple FS, McCune SA, Sharkey LC.

Cardiooncology. 2016;2. pii: 4. doi: 10.1186/s40959-016-0013-3. Epub 2016 Mar 15.


Building a roadmap to biomarker qualification: challenges and opportunities.

Amur SG, Sanyal S, Chakravarty AG, Noone MH, Kaiser J, McCune S, Buckman-Garner SY.

Biomark Med. 2015;9(11):1095-105. doi: 10.2217/bmm.15.90. Epub 2015 Nov 3.


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 M, Davis JM, Turner MA, Ward R, Bax R, Maldonado S, Sinha V, McCune SK, Zajicek A, Benjamin DK Jr, Bucci-Rechtweg C, Nelson RM.

Ther Innov Regul Sci. 2015 Sep;49(5):623-631. doi: 10.1177/2168479015597730.


A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development.

Wang J, Avant D, Green D, Seo S, Fisher J, Mulberg AE, McCune SK, Burckart GJ.

Clin Pharmacol Ther. 2015 Sep;98(3):328-35. doi: 10.1002/cpt.149. Review.


The pet factor--companion animals as a conduit for getting to know people, friendship formation and social support.

Wood L, Martin K, Christian H, Nathan A, Lauritsen C, Houghton S, Kawachi I, McCune S.

PLoS One. 2015 Apr 29;10(4):e0122085. doi: 10.1371/journal.pone.0122085. eCollection 2015.


Catalyzing the Critical Path Initiative: FDA's progress in drug development activities.

Parekh A, Buckman-Garner S, McCune S, ONeill R, Geanacopoulos M, Amur S, Clingman C, Barratt R, Rocca M, Hills I, Woodcock J.

Clin Pharmacol Ther. 2015 Mar;97(3):221-33. doi: 10.1002/cpt.42. Epub 2015 Jan 28.


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

McCune SK, Mulugeta YA.

Front Pediatr. 2014 Dec 1;2:135. doi: 10.3389/fped.2014.00135. eCollection 2014. Review. No abstract available.


Laminar and cellular analyses of reduced somatostatin gene expression in the subgenual anterior cingulate cortex in major depression.

Seney ML, Tripp A, McCune S, Lewis DA, Sibille E.

Neurobiol Dis. 2015 Jan;73:213-9. doi: 10.1016/j.nbd.2014.10.005. Epub 2014 Oct 12.


Evaluation of a pet-assisted living intervention for improving functional status in assisted living residents with mild to moderate cognitive impairment: a pilot study.

Friedmann E, Galik E, Thomas SA, Hall PS, Chung SY, McCune S.

Am J Alzheimers Dis Other Demen. 2015 May;30(3):276-89. doi: 10.1177/1533317514545477. Epub 2014 Aug 11.


Paedomorphic facial expressions give dogs a selective advantage.

Waller BM, Peirce K, Caeiro CC, Scheider L, Burrows AM, McCune S, Kaminski J.

PLoS One. 2013 Dec 26;8(12):e82686. doi: 10.1371/journal.pone.0082686. eCollection 2013.


Delta-6-desaturase links polyunsaturated fatty acid metabolism with phospholipid remodeling and disease progression in heart failure.

Le CH, Mulligan CM, Routh MA, Bouma GJ, Frye MA, Jeckel KM, Sparagna GC, Lynch JM, Moore RL, McCune SA, Bristow M, Zarini S, Murphy RC, Chicco AJ.

Circ Heart Fail. 2014 Jan;7(1):172-83. doi: 10.1161/CIRCHEARTFAILURE.113.000744. Epub 2013 Nov 27. Erratum in: Circ Heart Fail. 2014 Mar 1;7(2):382.


Effects of Animal-Assisted Activities with Guinea Pigs in the Primary School Classroom.

O'Haire ME, McKenzie SJ, McCune S, Slaughter V.

Anthrozoos. 2013;26(3). doi: 10.2752/175303713X13697429463835.


Effects of classroom animal-assisted activities on social functioning in children with autism spectrum disorder.

O'Haire ME, McKenzie SJ, McCune S, Slaughter V.

J Altern Complement Med. 2014 Mar;20(3):162-8. doi: 10.1089/acm.2013.0165. Epub 2013 Oct 24.


Should the veterinary profession invest in developing methods to assess quality of life in healthy dogs and cats?

Spofford N, Lefebvre SL, McCune S, Niel L.

J Am Vet Med Assoc. 2013 Oct 1;243(7):952-6. doi: 10.2460/javma.243.7.952. No abstract available.


A cross-sectional study of frequency and factors associated with dog walking in 9-10 year old children in Liverpool, UK.

Westgarth C, Boddy LM, Stratton G, German AJ, Gaskell RM, Coyne KP, Bundred P, McCune S, Dawson S.

BMC Public Health. 2013 Sep 10;13:822. doi: 10.1186/1471-2458-13-822.


Differential cardiotoxicity in response to chronic doxorubicin treatment in male spontaneous hypertension-heart failure (SHHF), spontaneously hypertensive (SHR), and Wistar Kyoto (WKY) rats.

Sharkey LC, Radin MJ, Heller L, Rogers LK, Tobias A, Matise I, Wang Q, Apple FS, McCune SA.

Toxicol Appl Pharmacol. 2013 Nov 15;273(1):47-57. doi: 10.1016/j.taap.2013.08.012. Epub 2013 Aug 28.


Living Beyond the Other.

McCune SL.

Pastoral Psychol. 2013 Aug;62(4):461-471.


Pet ownership, dog types and attachment to pets in 9-10 year old children in Liverpool, UK.

Westgarth C, Boddy LM, Stratton G, German AJ, Gaskell RM, Coyne KP, Bundred P, McCune S, Dawson S.

BMC Vet Res. 2013 May 13;9:102. doi: 10.1186/1746-6148-9-102.


The AIN-76A defined rodent diet accelerates the development of heart failure in SHHF rats: a cautionary note on its use in cardiac studies.

Rees ML, Gioscia-Ryan RA, McCune SA, Browder JC, Zachman DK, Chicco AJ, Johnson CA, Murphy RC, Moore RL, Sparagna GC.

J Anim Physiol Anim Nutr (Berl). 2014 Feb;98(1):56-64. doi: 10.1111/jpn.12031. Epub 2013 Jan 9.


Is childhood obesity influenced by dog ownership? No cross-sectional or longitudinal evidence.

Westgarth C, Heron J, Ness AR, Bundred P, Gaskell RM, Coyne K, German AJ, McCune S, Dawson S.

Obes Facts. 2012;5(6):833-44. doi: 10.1159/000345963. Epub 2012 Dec 8.


Impaired response to exercise intervention in the vasculature in metabolic syndrome.

Knaub LA, McCune S, Chicco AJ, Miller M, Moore RL, Birdsey N, Lloyd MI, Villarreal J, Keller AC, Watson PA, Reusch JE.

Diab Vasc Dis Res. 2013 May;10(3):222-38. doi: 10.1177/1479164112459664. Epub 2012 Nov 16.


Interspecies interactions and potential Influenza A virus risk in small swine farms in Peru.

McCune S, Arriola CS, Gilman RH, Romero MA, Ayvar V, Cama VA, Montgomery JM, Gonzales AE, Bayer AM.

BMC Infect Dis. 2012 Mar 15;12:58. doi: 10.1186/1471-2334-12-58.


Dietary linoleate preserves cardiolipin and attenuates mitochondrial dysfunction in the failing rat heart.

Mulligan CM, Sparagna GC, Le CH, De Mooy AB, Routh MA, Holmes MG, Hickson-Bick DL, Zarini S, Murphy RC, Xu FY, Hatch GM, McCune SA, Moore RL, Chicco AJ.

Cardiovasc Res. 2012 Jun 1;94(3):460-8. doi: 10.1093/cvr/cvs118. Epub 2012 Mar 12.


Dog ownership during pregnancy, maternal activity, and obesity: a cross-sectional study.

Westgarth C, Liu J, Heron J, Ness AR, Bundred P, Gaskell RM, German AJ, McCune S, Dawson S.

PLoS One. 2012;7(2):e31315. doi: 10.1371/journal.pone.0031315. Epub 2012 Feb 15.


The critical path initiative: leveraging collaborations to enhance regulatory science.

Barratt RA, Bowens SL, McCune SK, Johannessen JN, Buckman SY.

Clin Pharmacol Ther. 2012 Mar;91(3):380-3. doi: 10.1038/clpt.2011.318.


Crosstalk between leptin and interleukin-1β abrogates negative inotropic effects in a model of chronic hyperleptinemia.

Radin MJ, Holycross BJ, McCune SA, Altschuld RA.

Exp Biol Med (Maywood). 2011 Nov;236(11):1263-73. doi: 10.1258/ebm.2011.011144. Epub 2011 Sep 27.


Cardiac HDAC6 catalytic activity is induced in response to chronic hypertension.

Lemon DD, Horn TR, Cavasin MA, Jeong MY, Haubold KW, Long CS, Irwin DC, McCune SA, Chung E, Leinwand LA, McKinsey TA.

J Mol Cell Cardiol. 2011 Jul;51(1):41-50. doi: 10.1016/j.yjmcc.2011.04.005. Epub 2011 Apr 23.


Family pet ownership during childhood: findings from a UK birth cohort and implications for public health research.

Westgarth C, Heron J, Ness AR, Bundred P, Gaskell RM, Coyne KP, German AJ, McCune S, Dawson S.

Int J Environ Res Public Health. 2010 Oct;7(10):3704-29. doi: 10.3390/ijerph7103704. Epub 2010 Oct 18.


Vitamin D deficiency in the spontaneously hypertensive heart failure [SHHF] prone rat.

Przybylski R, McCune S, Hollis B, Simpson RU.

Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):641-6. doi: 10.1016/j.numecd.2009.07.009. Epub 2009 Oct 15.


The role of calcium-independent phospholipase A2 in cardiolipin remodeling in the spontaneously hypertensive heart failure rat heart.

Zachman DK, Chicco AJ, McCune SA, Murphy RC, Moore RL, Sparagna GC.

J Lipid Res. 2010 Mar;51(3):525-34. doi: 10.1194/jlr.M000646. Epub 2009 Sep 9.


Cardiolipin biosynthesis and remodeling enzymes are altered during development of heart failure.

Saini-Chohan HK, Holmes MG, Chicco AJ, Taylor WA, Moore RL, McCune SA, Hickson-Bick DL, Hatch GM, Sparagna GC.

J Lipid Res. 2009 Aug;50(8):1600-8. doi: 10.1194/jlr.M800561-JLR200. Epub 2008 Nov 10.


Salt-induced cardiac hypertrophy is independent of blood pressure and endothelin in obese, heart failure-prone SHHF rats.

Radin MJ, Holycross BJ, Hoepf TM, McCune SA.

Clin Exp Hypertens. 2008 Oct;30(7):541-52. doi: 10.1080/10641960802251917.


Linoleate-rich high-fat diet decreases mortality in hypertensive heart failure rats compared with lard and low-fat diets.

Chicco AJ, Sparagna GC, McCune SA, Johnson CA, Murphy RC, Bolden DA, Rees ML, Gardner RT, Moore RL.

Hypertension. 2008 Sep;52(3):549-55. doi: 10.1161/HYPERTENSIONAHA.108.114264. Epub 2008 Jul 28.


Substance abuse in pregnant women: making improved detection a good clinical outcome.

Araojo R, McCune S, Feibus K.

Clin Pharmacol Ther. 2008 Apr;83(4):520-2. doi: 10.1038/clpt.2008.13.


Animal studies in the development of medical countermeasures.

Roberts R, McCune SK.

Clin Pharmacol Ther. 2008 Jun;83(6):918-20. doi: 10.1038/clpt.2008.23. Epub 2008 Mar 5. Review.


Low-intensity exercise training delays heart failure and improves survival in female hypertensive heart failure rats.

Chicco AJ, McCune SA, Emter CA, Sparagna GC, Rees ML, Bolden DA, Marshall KD, Murphy RC, Moore RL.

Hypertension. 2008 Apr;51(4):1096-102. doi: 10.1161/HYPERTENSIONAHA.107.107078. Epub 2008 Feb 7.


FDA perspective on antivirals against biothreats: communicate early and often.

Roberts R, Styrt B, McCune S.

Antiviral Res. 2008 Apr;78(1):60-3. Epub 2007 Nov 5.


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