Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric Gluconate

Author:

Brandis Joel E. P.1ORCID,Kihn Kyle C.1,Taraban Marc B.1ORCID,Schnorr Julia2,Confer Alex M.3ORCID,Batelu Sharon4,Sun Dajun5,Rodriguez Jason D.6,Jiang Wenlei5,Goldberg David P.3ORCID,Langguth Peter2,Stemmler Timothy L.4ORCID,Yu Yihua Bruce1,Kane Maureen A.1ORCID,Polli James E.1ORCID,Michel Sarah L. J.1ORCID

Affiliation:

1. Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, Maryland 21201, United States

2. Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University Mainz, Staudingerweg 5, 55128 Mainz, Germany

3. Department of Chemistry, The Johns Hopkins University, Baltimore, Maryland 21218, United States

4. Department of Pharmaceutical Sciences, Wayne State University, Detroit, Michigan 48201, United States

5. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States

6. Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, MO 20903, United States

Funder

U.S. Food and Drug Administration

National Institute of General Medical Sciences

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Reference52 articles.

1. Minimum information reporting in bio–nano experimental literature

2. Nanotechnology and Nanomedicine: Start small, think big

3. FDA Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; FDA, Office of the Commissioner, 2014.

4. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date

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