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1.

FABry Disease Patient-Reported Outcome-GastroIntestinal (FABPRO-GI): A new Fabry disease-specific gastrointestinal outcomes instrument.

Shields, Alan L; Lamoureux, Roger E; Taylor, Fiona; Barth, Jay A; Mulberg, Andrew E; Kessler, Vivian; Skuban, Nina.

Qual Life Res ; 30(10): 2983-2994, 2021 Oct.

Article in English | MEDLINE | ID: mdl-33914257

2.

Reply.

Goldkind, Lawrence; Mulberg, Andrew E; Soreth, Janice.

Gastroenterology ; 164(3): 496, 2023 Mar.

Article in English | MEDLINE | ID: mdl-35934061

3.

Regulatory and Clinical Expert Perspective of the 2022 FDA Draft Guidance "Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet".

Goldkind, Lawrence; Soreth, Janice M; Mulberg, Andrew E.

Gastroenterology ; 164(3): 317-319, 2023 03.

Article in English | MEDLINE | ID: mdl-35810780

4.

Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.

Reinisch, Walter; Gottlieb, Klaus; Colombel, Jean-Frederic; Danese, Silvio; Panaccione, Remo; Panes, Julian; Peyrin-Biroulet, Laurent; Rubin, David; Sands, Bruce E; Schreiber, Stefan; Vermeire, Severine; Mulberg, Andrew; Sandborn, Bill.

Clin Gastroenterol Hepatol ; 17(9): 1673-1679.e1, 2019 08.

Article in English | MEDLINE | ID: mdl-31352970

5.

Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children.

Mulberg, Andrew E; Cripps, Timothy.

Curr Ther Res Clin Exp ; 90: 109-112, 2019.

Article in English | MEDLINE | ID: mdl-31388364

6.

Pediatric Extrapolation of Adult Efficacy to Children Is Critical for Efficient and Successful Drug Development.

Mulberg, Andrew E; Conklin, Laurie S; Croft, Nicholas M.

Gastroenterology ; 163(1): 77-83, 2022 07.

Article in English | MEDLINE | ID: mdl-35288113

7.

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

Sun, Haihao; Vesely, Richard; Lee, Kerry Jo; Klein, Agnes; Ikima, Mutsuhiro; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-27253661

8.

Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.

Earp, Justin C; Mehrotra, Nitin; Peters, Kristina E; Fiorentino, Robert P; Griebel, Donna; Lee, Sue C; Mulberg, Andrew; Röhss, Kerstin; Sandström, Marie; Taylor, Amy; Tornøe, Christoffer W; Wynn, Erica L; Van der Walt, Jan-Stefan; Garnett, Christine.

J Pediatr Gastroenterol Nutr ; 65(3): 272-277, 2017 09.

Article in English | MEDLINE | ID: mdl-27875488

9.

Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions.

Shapiro, Elsa; Bernstein, Jessica; Adams, Heather R; Barbier, Ann J; Buracchio, Teresa; Como, Peter; Delaney, Kathleen A; Eichler, Florian; Goldsmith, Jonathan C; Hogan, Melissa; Kovacs, Sarrit; Mink, Jonathan W; Odenkirchen, Joanne; Parisi, Melissa A; Skrinar, Alison; Waisbren, Susan E; Mulberg, Andrew E.

Mol Genet Metab ; 118(2): 65-9, 2016 06.

Article in English | MEDLINE | ID: mdl-27132782

10.

Nutritional interventions in primary mitochondrial disorders: Developing an evidence base.

Camp, Kathryn M; Krotoski, Danuta; Parisi, Melissa A; Gwinn, Katrina A; Cohen, Bruce H; Cox, Christine S; Enns, Gregory M; Falk, Marni J; Goldstein, Amy C; Gopal-Srivastava, Rashmi; Gorman, Gráinne S; Hersh, Stephen P; Hirano, Michio; Hoffman, Freddie Ann; Karaa, Amel; MacLeod, Erin L; McFarland, Robert; Mohan, Charles; Mulberg, Andrew E; Odenkirchen, Joanne C; Parikh, Sumit; Rutherford, Patricia J; Suggs-Anderson, Shawne K; Tang, W H Wilson; Vockley, Jerry; Wolfe, Lynne A; Yannicelli, Steven; Yeske, Philip E; Coates, Paul M.

Mol Genet Metab ; 119(3): 187-206, 2016 11.

Article in English | MEDLINE | ID: mdl-27665271

11.

Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients.

Wang, Jian; Mehrotra, Nitin; Kim, Insook; Lee, Sue-Chih; Sohrabi, Farrokh; He, Ruyi; Mulberg, Andrew; Sinha, Vikram; Ahn, Hae-Young; Bashaw, Dennis; Griebel, Donna.

J Pediatr Gastroenterol Nutr ; 63(4): 412-6, 2016 10.

Article in English | MEDLINE | ID: mdl-26913757

12.

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

Sun, Haihao; Papadopoulos, Elektra J; Hyams, Jeffrey S; Griebel, Donna; Lee, Jessica J; Tomaino, Juli; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-25793905

13.

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

Camp, Kathryn M; Parisi, Melissa A; Acosta, Phyllis B; Berry, Gerard T; Bilder, Deborah A; Blau, Nenad; Bodamer, Olaf A; Brosco, Jeffrey P; Brown, Christine S; Burlina, Alberto B; Burton, Barbara K; Chang, Christine S; Coates, Paul M; Cunningham, Amy C; Dobrowolski, Steven F; Ferguson, John H; Franklin, Thomas D; Frazier, Dianne M; Grange, Dorothy K; Greene, Carol L; Groft, Stephen C; Harding, Cary O; Howell, R Rodney; Huntington, Kathleen L; Hyatt-Knorr, Henrietta D; Jevaji, Indira P; Levy, Harvey L; Lichter-Konecki, Uta; Lindegren, Mary Lou; Lloyd-Puryear, Michele A; Matalon, Kimberlee; MacDonald, Anita; McPheeters, Melissa L; Mitchell, John J; Mofidi, Shideh; Moseley, Kathryn D; Mueller, Christine M; Mulberg, Andrew E; Nerurkar, Lata S; Ogata, Beth N; Pariser, Anne R; Prasad, Suyash; Pridjian, Gabriella; Rasmussen, Sonja A; Reddy, Uma M; Rohr, Frances J; Singh, Rani H; Sirrs, Sandra M; Stremer, Stephanie E; Tagle, Danilo A.

Mol Genet Metab ; 112(2): 87-122, 2014 Jun.

Article in English | MEDLINE | ID: mdl-24667081

14.

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

Sun, Haihao; Lee, Jessica J; Papadopoulos, Elektra J; Lee, Catherine S; Nelson, Robert M; Sachs, Hari C; Rodriguez, William J; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-24121142

15.

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

Sun, Haihao; Vesely, Richard; Taminiau, Jan; Szitanyi, Peter; Papadopoulos, Elektra J; Isaac, Maria; Klein, Agnes; Uzu, Shinobu; Griebel, Donna; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-24866781

16.

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

Sun, Haihao; Vesely, Richard; Nelson, Robert M; Taminiau, Jan; Szitanyi, Peter; Isaac, Maria; Klein, Agnes; Uzu, Shinobu; Griebel, Donna; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-24866782

17.

Expanding research to provide an evidence base for nutritional interventions for the management of inborn errors of metabolism.

Camp, Kathryn M; Lloyd-Puryear, Michele A; Yao, Lynne; Groft, Stephen C; Parisi, Melissa A; Mulberg, Andrew; Gopal-Srivastava, Rashmi; Cederbaum, Stephen; Enns, Gregory M; Ershow, Abby G; Frazier, Dianne M; Gohagan, John; Harding, Cary; Howell, R Rodney; Regan, Karen; Stacpoole, Peter W; Venditti, Charles; Vockley, Jerry; Watson, Michael; Coates, Paul M.

Mol Genet Metab ; 109(4): 319-28, 2013 Aug.

Article in English | MEDLINE | ID: mdl-23806236

18.

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

Karesh, Alyson; Tomaino, Juli; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-23995427

19.

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

Fiorentino, Robert; Liu, Gumei; Pariser, Anne R; Mulberg, Andrew E.

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

Article in English | MEDLINE | ID: mdl-22857796

20.

Development of Celiac Disease Therapeutics: Report of the Third Gastroenterology Regulatory Endpoints and Advancement of Therapeutics Workshop.

Leffler, Daniel; Kupfer, Sonia S; Lebwohl, Benjamin; Bugin, Kevin; Griebel, Donna; Lathrop, Julia Tait; Lee, Jessica J; Mulberg, Andrew E; Papadopoulos, Elektra; Tomaino, Juli; Crowe, Sheila E.

Gastroenterology ; 151(3): 407-11, 2016 09.

Article in English | MEDLINE | ID: mdl-27456385

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