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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.
Benkstein, Kurt D; Balakrishnan, Gurusamy; Bhirde, Ashwinkumar; Chalus, Pascal; Das, Tapan K; Do, Ngoc; Duewer, David L; Filonov, Nazar; Cheong, Fook Chiong; Garidel, Patrick; Gill, Nicole S; Grabarek, Adam D; Grier, David G; Hadley, Judith; Hollingsworth, Andrew D; Howard, Wesley W; Jarzebski, Maciej; Jiskoot, Wim; Kar, Sambit R; Kestens, Vikram; Khasa, Harshit; Kim, Yoen Joo; Koulov, Atanas; Matter, Anja; Philips, Laura A; Probst, Christine; Ramaye, Yannic; Randolph, Theodore W; Ripple, Dean C; Romeijn, Stefan; Saggu, Miguel; Schleinzer, Franziska; Snell, Jared R; Tatarkiewicz, Jan Kuba; Wright, Heather Anne; Yang, Dennis T.
Afiliação
  • Benkstein KD; Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA. Electronic address: kurt.benkstein@nist.gov.
  • Balakrishnan G; Analytical Development and Attribute Science, Bristol Myers Squibb, New Brunswick, NJ 08901, USA.
  • Bhirde A; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
  • Chalus P; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, CH-4057 Basel, Switzerland.
  • Das TK; Biologics Development, Bristol Myers Squibb, New Brunswick, NJ 08903, USA.
  • Do N; Spectradyne LLC, 23875 Madison St Suite A, Torrance CA 90505, USA.
  • Duewer DL; Chemical Sciences Division, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA.
  • Filonov N; AlphaNanoTech, Morrisville, NC 27709, USA; Particle Metrix, Inc., Mebane, NC 27302, USA.
  • Cheong FC; Spheryx, Inc., New York, NY 10016, USA.
  • Garidel P; Boehringer Ingelheim Pharma GmbH & Co. KG, Innovation Unit, PDB, D-88397 Biberach an der Riss, Germany.
  • Gill NS; Yokogawa Fluid Imaging Technologies, Inc. Scarborough, ME 04074, USA.
  • Grabarek AD; Coriolis Pharma, Fraunhoferstrasse 18 b, 82152 Martinsried, Germany; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, The Netherlands.
  • Grier DG; Department of Physics and Center for Soft Matter Research, New York University, New York, NY 10003, USA.
  • Hadley J; Malvern Pananalytical, 117 Flanders Road Westborough, MA 01581, USA.
  • Hollingsworth AD; Department of Physics and Center for Soft Matter Research, New York University, New York, NY 10003, USA.
  • Howard WW; Analytical Sciences, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, USA.
  • Jarzebski M; Department of Physics and Biophysics, Faculty of Food Science and Nutrition, Poznan University of Life Sciences, Poznan, Poland.
  • Jiskoot W; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
  • Kar SR; Biologics Development, Bristol Myers Squibb, New Brunswick, NJ 08903, USA.
  • Kestens V; European Commission, Joint Research Centre (JRC), Geel, Belgium.
  • Khasa H; Analytical Sciences, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, USA.
  • Kim YJ; Analytical Sciences, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, USA.
  • Koulov A; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, CH-4057 Basel, Switzerland.
  • Matter A; Lonza AG, Drug Product Services, Hochbergerstrasse 60G, CH-4057 Basel, Switzerland.
  • Philips LA; Spheryx, Inc., New York, NY 10016, USA.
  • Probst C; Luminex Corporation, Seattle, WA 98119, USA.
  • Ramaye Y; European Commission, Joint Research Centre (JRC), Geel, Belgium.
  • Randolph TW; Department of Chemical and Biological Engineering, University of Colorado, Boulder, CO 80309.
  • Ripple DC; Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD 20899, USA.
  • Romeijn S; Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
  • Saggu M; Pharmaceutical Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
  • Schleinzer F; Boehringer Ingelheim Pharma GmbH & Co. KG, Innovation Unit, PDB, D-88397 Biberach an der Riss, Germany.
  • Snell JR; Department of Chemical and Biological Engineering, University of Colorado, Boulder, CO 80309.
  • Tatarkiewicz JK; HORIBA Scientific, Irvine, CA 92618, USA.
  • Wright HA; Yokogawa Fluid Imaging Technologies, Inc. Scarborough, ME 04074, USA.
  • Yang DT; Biopharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
J Pharm Sci ; 111(3): 699-709, 2022 03.
Article em En | MEDLINE | ID: mdl-34808214
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Software / Laboratórios Idioma: En Revista: J Pharm Sci Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Software / Laboratórios Idioma: En Revista: J Pharm Sci Ano de publicação: 2022 Tipo de documento: Article