Search Results - "Destefano, Anthony J."

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations by Fast, Douglas M., Kelley, Marian, Viswanathan, C. T., O’Shaughnessy, Jacqueline, King, S. Peter, Chaudhary, Ajai, Weiner, Russell, DeStefano, Anthony J., Tang, Daniel

“…The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in…”
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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays by Viswanathan, C T, Bansal, Surendra, Booth, Brian, DeStefano, Anthony J, Rose, Mark J, Sailstad, Jeffrey, Shah, Vinod P, Skelly, Jerome P, Swann, Patrick G, Weiner, Russell

“…The Third AAPS/FDA Bioanalytical Workshop, entitled "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and…”
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Metal Impurities in Food and Drugs by Abernethy, Darrell R, DeStefano, Anthony J, Cecil, Todd L, Zaidi, Kahkashan, Williams, Roger L

“…The major metals of potential health concern found in food, drugs (medicines), and dietary supplements are lead, cadmium, mercury, and arsenic. Other metals,…”
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Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas by Löbenberg, Raimar, Chacra, Nadia B., Stippler, Erika S., Shah, Vinod P., DeStefano, Anthony J., Hauck, Walter W., Williams, Roger L.

“…This study compared in vitro dissolution characteristics and other quality measures of different amoxicillin, metronidazole, and zidovudine products purchased…”
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Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard by DeStefano, Anthony J, Hauck, Walter W, Stippler, Erika S, Brown, William E, Li, Chensheng, Huang, Gloria G, Jones, Barbara J, O'Hool, Kevin, Koch, William F, Williams, Roger L

“…Purpose On 1 March 2010, the US Pharmacopeial Convention released into commerce Lot P1I300 of its Prednisone Tablets Reference Standard for use in periodic…”
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Role of public quality standards for biological medicines by DeStefano, Anthony J, Morris, Tina S

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Erratum to: “Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus 1 and 2 Using USPC Prednisone Tablets Reference Standard” by DeStefano, Anthony J., Hauck, Walter W., Stippler, Erika S., Brown, William E., Li, Chensheng, Huang, Gloria G., Jones, Barbara J., O’Hool, Kevin, Koch, William F., Williams, Roger L.

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Change in Criteria for USP Dissolution Performance Verification Tests by Hauck, Walter W., DeStefano, Anthony J., Brown, William E., Stippler, Erika S., Abernethy, Darrell R., Koch, William F., Williams, Roger L.

“…The US Pharmacopeial Convention has been evaluating its performance verification tests (PVT) for several years. These tests help ensure the integrity of the US…”
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Influence of ketoconazole on azimilide pharmacokinetics in healthy subjects by El Mouelhi, Mohamed, Worley, Dan J., Kuzmak, Barbara, Destefano, Anthony J., Thompson, Gary A.

“…Aim  To assess the influence of ketoconazole on azimilide pharmacokinetics. Methods  A two‐period randomized crossover study was conducted in healthy male and…”
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Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays by Viswanathan, C. T., Bansal, Surendra, Booth, Brian, DeStefano, Anthony J., Rose, Mark J., Sailstad, Jeffrey, Shah, Vinod P., Skelly, Jerome P., Swann, Patrick G., Weiner, Russell

“…For quantitative bioanalytical method validation procedure and requirements, there was a relatively good agreement between chromatographic assays and…”
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Influence of Azimilide on CYP2C19-Mediated Metabolism by El Mouelhi, Mohamed, Worley, Dan J., Kuzmak, Barbara, Destefano, Anthony J., Thompson, Gary A.

“…The purpose of this study was to assess the influence of multiple‐dose oral administration of azimilide dihydrochloride on CYP2C19‐mediated metabolism. A…”
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Establishing New Acceptance Limits for Dissolution Performance Verification of USPC Apparatus I and 2 Using USPC Prednisone Tablets Reference Standard by DESTEFANO, Anthony J, HAUCK, Walter W, STIPPLER, Erika S, BROWN, William E, CHENSHENG LI, HUANG, Gloria G, JONES, Barbara J, O'HOOL, Kevin, KOCH, William F, WILLIAMS, Roger L

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Modernization of USP standards: the US pharmacopeial convention continues to make modernization of standards a top priority in 2013 by DeStefano, Anthony J

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Acidity of pentaborane(9)(1+) and stability of the pentaborane(8) radical by Wang, Jia-Shen, DeStefano, Anthony J, Porter, Richard F

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Difluoroborane, a hydrogen-deuterium exchange catalyst for the preparation of B-trideuterioborazines by DeStefano, Anthony J, Porter, Richard F

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Ion-molecule reactions of cyclic borazine cations. Thermodynamic and kinetic considerations by DeStefano, Anthony J, Porter, Richard F

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Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests by Hauck, Walter W., DeStefano, Anthony J., Brown, William E., Stippler, Erika S., Abernethy, Darrell R., Williams, Roger L.

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Modernization of USP Standards by DeStefano, Anthony J

“…Modernization of monograph and general chapter standards will continue to be a top priority for the US Pharmacopeial Convention (USP) in 2013. USP also will…”
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USP Metals Testing by Schuber, Stefan, DeStefano, Anthony J, Williams, Roger L, Koch, William F, Abernethy, Darrell R

“…The US Pharmacopeial Convention (USPC) asked the Institute of Medicine (IOM) of the National Academy of Sciences to convene a workshop at which stakeholders,…”
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USP metals testing: a workshop report: attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients by Schuber, Stefan, DeStefano, Anthony J, Williams, Roger L, Koch, William F, Abernethy, Darrell R

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