Andrew E Mulberg

Andrew E Mulberg

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Andrew E Mulberg

Andrew E Mulberg

Publications by authors named "Andrew E Mulberg"

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33Publications

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Pediatric Intestinal Failure-Associated Liver Disease: Challenges in Identifying Clinically Relevant Biomarkers.

JPEN J Parenter Enteral Nutr 2018 02 12;42(2):455-462. Epub 2017 Dec 12.

Vascular Biology Program and Department of Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1177/0148607116671781DOI Listing
February 2018

Pediatric Crohn Disease Clinical Outcome Assessments and Biomarkers: Current State and Path Forward for Global Collaboration.

J Pediatr Gastroenterol Nutr 2017 03;64(3):368-372

*United States Food and Drug Administration, Silver Spring, MD †European Medicines Agency, London, UK ‡Health Canada, Ottawa, Ontario, Canada §Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

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http://dx.doi.org/10.1097/MPG.0000000000001284DOI Listing
March 2017

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

J Clin Pharmacol 2016 11;56(11):1326-1334

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1002/jcph.744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5482171PMC
November 2016

Literature Review of Gastrointestinal Physiology in the Elderly, in Pediatric Patients, and in Patients with Gastrointestinal Diseases.

J Pharm Sci 2016 Feb 12;105(2):476-483. Epub 2016 Jan 12.

Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993.

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https://linkinghub.elsevier.com/retrieve/pii/S00223549150016
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http://dx.doi.org/10.1002/jps.24696DOI Listing
February 2016

Well-defined and reliable clinical outcome assessments for pediatric Crohn disease: a critical need for drug development.

J Pediatr Gastroenterol Nutr 2015 Jun;60(6):729-36

*Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration †Study Endpoint and Labeling Development, Office of New Drugs, Center for Drug Research and Evaluation, Food and Drug Administration, Silver Spring, MD ‡Connecticut Children's Medical Center, Hartford §Division of Gastroenterology and Inborn Errors Products, Office of New Drug, Center for Drug Research and Evaluation, Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1097/MPG.0000000000000793DOI Listing
June 2015

Dependence of PERT endpoint on endogenous lipase activity.

Pancreas 2014 Nov;43(8):1232-8

From the Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1097/MPA.0000000000000214DOI Listing
November 2014

Phenylketonuria Scientific Review Conference: state of the science and future research needs.

Mol Genet Metab 2014 Jun 6;112(2):87-122. Epub 2014 Mar 6.

The Young Face, Facial Plastic and Reconstructive Surgery, Cumming, GA 30041, USA. Electronic address:

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https://www.team-share.net/Phenylketonuria_Scientific_Review
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http://linkinghub.elsevier.com/retrieve/pii/S109671921400085
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http://dx.doi.org/10.1016/j.ymgme.2014.02.013DOI Listing
June 2014

Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 1: efficacy endpoints and disease outcome assessments.

J Pediatr Gastroenterol Nutr 2014 Jun;58(6):679-83

*US Food and Drug Administration, Silver Spring, MD †European Medicines Agency, London, UK ‡Health Canada, Ottawa, Ontario, Canada §Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

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http://dx.doi.org/10.1097/MPG.0000000000000306DOI Listing
June 2014

Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.

J Pediatr Gastroenterol Nutr 2014 Jun;58(6):684-8

*US Food and Drug Administration, Silver Spring, MD †European Medicines Agency, London, UK ‡Health Canada, Ottawa, Ontario, Canada §Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

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http://dx.doi.org/10.1097/MPG.0000000000000322DOI Listing
June 2014

Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.

J Pediatr Gastroenterol Nutr 2014 Jan;58(1):12-7

*Office of Pediatric Therapeutics, Office of the Commissioner †Division of Gastroenterology and Inborn Errors Products ‡Study Endpoint and Labeling Development (SEALD) §Pediatrics and Maternal Health Staff, Office of New Drug, Center for Drug Research and Evaluation, Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1097/MPG.0000000000000186DOI Listing
January 2014

Off-label use of medicine in pediatrics: focus on gastrointestinal diseases.

Curr Opin Pediatr 2013 Oct;25(5):612-7

aPediatric and Maternal Health Staff bDivision of Gastroenterology and Inborn Errors Products, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1097/MOP.0b013e328363ed4eDOI Listing
October 2013

US perspective on off-label use in pediatrics.

J Pediatr Gastroenterol Nutr 2013 Feb;56(2):113-4

Division of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1097/MPG.0b013e3182824ccbDOI Listing
February 2013

Drug development: The use of unlicensed/off-label medicines in pediatrics.

J Pediatr Gastroenterol Nutr 2012 Nov;55(5):506-10

Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Japan.

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http://dx.doi.org/10.1097/MPG.0b013e318272af1fDOI Listing
November 2012

Cross-sector sponsorship of research in eosinophilic esophagitis: a collaborative model for rational drug development in rare diseases.

J Allergy Clin Immunol 2012 Sep 31;130(3):613-6. Epub 2012 Jul 31.

Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1016/j.jaci.2012.07.011DOI Listing
September 2012

Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis.

J Cyst Fibros 2011 Sep 31;10(5):350-6. Epub 2011 May 31.

Division of Pulmonary Medicine and Biology, Cincinnati Children's Hospital Medical Center, OH, USA.

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http://dx.doi.org/10.1016/j.jcf.2011.04.005DOI Listing
September 2011

Pharmacokinetics and tolerability of rabeprazole in children 1 to 11 years old with gastroesophageal reflux disease.

J Pediatr Gastroenterol Nutr 2011 Jun;52(6):691-701

Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ 08560, USA.

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http://dx.doi.org/10.1097/MPG.0b013e318207834dDOI Listing
June 2011

Pharmaceutical industry in pediatric drug development: partners and collaborators with academia and the FDA.

Authors:
Andrew E Mulberg

J Pediatr Gastroenterol Nutr 2008 Nov;47(5):711-3

Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ 08560, USA.

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http://dx.doi.org/10.1097/01.mpg.0000338970.57088.89DOI Listing
November 2008

Relationship of dietary intake to gastrointestinal symptoms in children with autistic spectrum disorders.

Biol Psychiatry 2007 Feb 3;61(4):492-7. Epub 2007 Jan 3.

Division of Child Development and Rehabilitation, Children's Seashore House of the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.

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http://dx.doi.org/10.1016/j.biopsych.2006.07.013DOI Listing
February 2007

Resting energy expenditure is not increased in prepubertal children with Alagille syndrome.

J Pediatr 2006 May;148(5):680-2

Division of Gastroenterology and Nutrition at The Children's Hospital of Philadelphia, PA 19104, USA.

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http://dx.doi.org/10.1016/j.jpeds.2005.12.019DOI Listing
May 2006

Body composition of children aged 1 to 12 years with biliary atresia or Alagille syndrome.

J Pediatr Gastroenterol Nutr 2005 Feb;40(2):146-50

The Division of Gastroenterology and Nutrition, Children's Hospital of Philadelphia and The University of Pennsylvania School of Medicine, 34th and Civic Center Boulevard, Philadelphia, PA 19104, USA.

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http://dx.doi.org/10.1097/00005176-200502000-00012DOI Listing
February 2005

Deficits in size-adjusted bone mass in children with Alagille syndrome.

J Pediatr Gastroenterol Nutr 2005 Jan;40(1):76-82

Center for Epidemiology and Biostatistics and Division of Neonatology, Cincinnati Children's Hospital Medical Cente, The University of Cincinnati College of Medicine, Cincinnati, OH, USA.

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http://dx.doi.org/10.1097/00005176-200501000-00014DOI Listing
January 2005

Reduced expression of the cystic fibrosis transmembrane conductance regulator gene in the hypothalamus of patients with Alzheimer's disease.

J Alzheimers Dis 2003 Dec;5(6):455-62

Department of Medicine, Rhode Island Hospital and Brown Medical School, Providence, RI 02903, USA.

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December 2003

Intestinal cytokines in children with pervasive developmental disorders.

Am J Gastroenterol 2003 Aug;98(8):1777-82

Division of Gastroenterology and Nutrition, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA

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http://dx.doi.org/10.1111/j.1572-0241.2003.07593.xDOI Listing
August 2003

Rethinking growth failure in Alagille syndrome: the role of dietary intake and steatorrhea.

J Pediatr Gastroenterol Nutr 2002 Oct;35(4):495-502

Division of Gastroenterology and Nutrition, The Children's Hospital of Philadelphia, Pennsylvania 19104, USA.

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http://dx.doi.org/10.1097/00005176-200210000-00007DOI Listing
October 2002