Search Results - "DeStefano, Anthony"

Key elements of bioanalytical method validation for small molecules by Bansal, Surendra, DeStefano, Anthony

“…Method validation is a process that demonstrates that a method will successfully meet or exceed the minimum standards recommended in the Food and Drug…”
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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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Ion-Atom Charge-Exchange Collisions and Their Effect on Plasma-Neutral Coupling by DeStefano, Anthony M

“…The heliosphere is a cavity carved out of the interstellar medium by the supersonic outflow of solar wind (SW) from the Sun. The local interstellar medium…”
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Abstract B14: Strengthening CBPR collaboration between Pacific Islander community and academic research partners by DeStefano, Anthony, Aromin, Jay, Dimaculangan, Jeany, Vunileva, Isileli, Tanjasiri, Sora P., Peters, Ruth, Tui‘one, Vanessa, Takahashi, Lois, Sablan-Santos, Lola, Quitugu, Lourdes, Quenga, Joey, Hui, Brian, Barrera-Ng, Angelica

“…Community-based participatory research (CBPR), applied authentically according to its principles, is inherently conducive to empowerment and capacity building…”
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Striking the Maritime-Environmental Balance by Destefano, Anthony

“…The shipping industry is keenly aware that between 2 and 9 percent of a ship's operating budget goes toward environmental compliance. [...]criminal prosecution…”
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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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PQRI Workshop Report: Application of IVIVC in Formulation Development by Van Buskirk, Glenn A, Shah, Vinod, Yacobi, Avi, Bolger, Michael B, Chittenden, Jason, Davit, Barbara M, DeStefano, Anthony, Dressman, Jennifer, Duan, John Z, Ganes, Derek A, Gonzalez, Mario A, Gray, Vivian, Kakhi, Maziar, Li, Rong, Mirza, Tasheen, Polli, James E, Rackley, Russell J, Smith, Douglas F, Shephard, Theresa, Stippler, Erika, Suarez-Sharp, Sandra, Turner, David

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Challenges in Dissolution Testing by Marques, Margareth R.C, Brown, William, Giancaspro, Gabriel, Davydova, Natalia, Chang, Edith, Fringer, Jeanne, Hauck, Walter, DeStefano, Anthony

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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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