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PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.

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Title: PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.
Authors: Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA. gilbert.burckart@fda.hhs.gov., Abdel-Rahman S; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA., Choi C; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA., Cober MP; Northeast Ohio Medical University, College of Pharmacy, Rootstown, Ohio, USA., Cummins JE Jr; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Fotaki N; University of Bath, Bath, UK., Gonzalez D; Schoool of Medicine, Duke University, Durham, North Carolina, USA., Harris D; Merck & Co., Inc, Rahway, New Jersey, USA., Parrott N; Predictive Modeling, Pharmaceutical Sciences, Roche Pharma Research and Early Development, Basel, Switzerland., Patel H; Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Wu F; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Abend A; Merck & Co., Inc, Rahway, New Jersey, USA.
Source: The AAPS journal [AAPS J] 2026 Mar 09; Vol. 28 (2). Date of Electronic Publication: 2026 Mar 09.
Publication Type: Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
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  Data: PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.
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  Data: <searchLink fieldCode="AU" term="%22Burckart+GJ%22">Burckart GJ</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA. gilbert.burckart@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Abdel-Rahman+S%22">Abdel-Rahman S</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA.<br /><searchLink fieldCode="AU" term="%22Choi+C%22">Choi C</searchLink>; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA.<br /><searchLink fieldCode="AU" term="%22Cober+MP%22">Cober MP</searchLink>; Northeast Ohio Medical University, College of Pharmacy, Rootstown, Ohio, USA.<br /><searchLink fieldCode="AU" term="%22Cummins+JE+Jr%22">Cummins JE Jr</searchLink>; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Fotaki+N%22">Fotaki N</searchLink>; University of Bath, Bath, UK.<br /><searchLink fieldCode="AU" term="%22Gonzalez+D%22">Gonzalez D</searchLink>; Schoool of Medicine, Duke University, Durham, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Harris+D%22">Harris D</searchLink>; Merck & Co., Inc, Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Parrott+N%22">Parrott N</searchLink>; Predictive Modeling, Pharmaceutical Sciences, Roche Pharma Research and Early Development, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Patel+H%22">Patel H</searchLink>; Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Wu+F%22">Wu F</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Abend+A%22">Abend A</searchLink>; Merck & Co., Inc, Rahway, New Jersey, USA.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2026 Mar 09; Vol. 28 (2). <i>Date of Electronic Publication: </i>2026 Mar 09.
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              Text: 2026 Mar 09
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