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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

Autor: 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., Jarzębski 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.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2022 Mar; Vol. 111 (3), pp. 699-709. Date of Electronic Publication: 2021 Nov 20.

A long-term clinical trial on the efficacy and safety profile of doxofylline in Asthma: The LESDA study.

Autor: Calzetta L; Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome 'Tor Vergata', Rome, Italy. Electronic address: luigino.calzetta@uniroma2.it., Matera MG; Unit of Pharmacology, Department of Experimental Medicine, University of Campania 'Luigi Vanvitelli', Naples, Italy., Goldstein MF; The Asthma Center, Philadelphia, PA, USA., Fairweather WR; Flower Valley Consulting, Inc. Rockville, MD, USA., Howard WW; Alitair Pharmaceuticals, Inc, Morristown, NJ, USA., Cazzola M; Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome 'Tor Vergata', Rome, Italy., Rogliani P; Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome 'Tor Vergata', Rome, Italy.

Publikováno v: Pulmonary pharmacology & therapeutics [Pulm Pharmacol Ther] 2020 Feb; Vol. 60, pp. 101883. Date of Electronic Publication: 2019 Dec 26.