Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Anthony J. DeStefano"'
Autor:
Mario A. Gonzalez, Jennifer B. Dressman, Vivian A. Gray, Vinod P. Shah, Barbara M. Davit, Erika S. Stippler, Douglas F. Smith, Jason T. Chittenden, Glenn A. Van Buskirk, Russell J. Rackley, Rong Li, Theresa Shephard, Avi Yacobi, James E. Polli, David B. Turner, Sandra Suarez-Sharp, Michael B. Bolger, Maziar Kakhi, Derek A. Ganes, Anthony J. DeStefano, John Duan, Tasheen Mirza
Publikováno v:
Dissolution Technologies. 21:51-58
This article summarizes the proceeding of the September 2012 Workshop on Application of In vitro–In vivo correlation (IVIVC) in Formulation Development. The workshop brought together international experts with the goal of establishing common concep
Autor:
Anthony J. DeStefano, Vinod P. Shah, Raimar Löbenberg, Erika S. Stippler, Nadia Araci Bou Chacra, Roger Williams, Walter W. Hauck
Publikováno v:
Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual)
Universidade de São Paulo (USP)
instacron:USP
Universidade de São Paulo (USP)
instacron:USP
This study compared in vitro dissolution characteristics and other quality measures of different amoxicillin, metronidazole, and zidovudine products purchased in the Americas to a comparator pharmaceutical product (CPP). These three drugs are classif
Autor:
Kevin O’Hool, Barbara J. Jones, Roger L. Williams, Anthony J. DeStefano, William F. Koch, Chensheng Li, Gloria G. Huang, William Brown, Erika S. Stippler, Walter W. Hauck
Publikováno v:
Pharmaceutical Research. 28:505-516
On 1 March 2010, the US Pharmacopeial Convention released into commerce Lot P1I300 of its Prednisone Tablets Reference Standard for use in periodic performance verification testing (PVT) of dissolution Apparatus 1 and 2. This report presents the coll
Autor:
Anthony J. DeStefano, Daniel Tang, Jacqueline A. O'Shaughnessy, Marian Kelley, Ajai K. Chaudhary, S. Peter King, Russell Weiner, Douglas M. Fast, C. T. Viswanathan
Publikováno v:
The AAPS Journal. 11:238-241
The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Wor
Autor:
William F. Koch, William Brown, Anthony J. DeStefano, Roger L. Williams, Darrell R. Abernethy, Erika S. Stippler, Walter W. Hauck
Publikováno v:
AAPS PharmSciTech. 10:21-26
The US Pharmacopeial Convention has been evaluating its performance verification tests (PVT) for several years. These tests help ensure the integrity of the US Pharmacopeia performance test when a dissolution procedure, as described in General Chapte
Autor:
Leon Shargel, Anthony J. DeStefano, Thomas S. Foster, Walter W. Hauck, Clarence T. Ueda, Erika S. Stippler, W. Craig Simon, Vivian A. Gray, James E. Polli, William Brown, G. Bryan Crist, Eli Shefter, Roger L. Williams, Mario A. Gonzalez, Diane J. Burgess, Johannes Kraemer, Alan F. Parr, Darrell R. Abernethy, Lewis J. Leeson, Nhan L. Tran
Publikováno v:
Dissolution Technologies. 16:7-12
As part of its evaluation of the performance verification tests used periodically to affirm the integrity of the USP Performance test when General Chapter Dissolution is relied upon, the Biopharmaceutics Expert Committee of the Council of Experts, wo
Autor:
Mark J. Rose, Vinod P. Shah, Jeffrey Sailstad, C. T. Viswanathan, Jerome P. Skelly, Brian Booth, Patrick G. Swann, Surendra Bansal, Russell Weiner, Anthony J. Destefano
Publikováno v:
Pharmaceutical Research. 24:1962-1973
The Third AAPS/FDA Bioanalytical Workshop, entitled "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays" was held on May 1-3, 2006 in Arlington, VA. The format of this worksh
Autor:
Anthony J. Destefano, Surendra Bansal
Publikováno v:
The AAPS Journal. 9:E109-E114
Method validation is a process that demonstrates that a method will successfully meet or exceed the minimum standards recommended in the Food and Drug Administration (FDA) guidance for accuracy, precision, selectivity, sensitivity, reproducibility, a
Autor:
Jeanne M. Fringer, Anthony J. DeStefano, Edith Chang, Walter W. Hauck, Margareth Marques, Gabriel I. Giancaspro, Natalia N Davydova, William Brown
Publikováno v:
Dissolution Technologies. 19:39-41
Dissolution testing of dosage forms is an activity in continuous development, both for improving equipment and its performance qualification and for selecting the best test conditions. The U. S. Pharmacopeia (USP) held a workshop coordinated by some
Autor:
Anthony J. DeStefano, Usp Metal Impurities Advisory Panel, Darrell R. Abernethy, Todd L. Cecil, Kahkashan Zaidi, Roger L. Williams
Publikováno v:
Pharmaceutical research. 27(5)
The major metals of potential health concern found in food, drugs (medicines), and dietary supplements are lead, cadmium, mercury, and arsenic. Other metals, such as chromium, copper, manganese, molybdenum, vanadium, nickel, osmium, rhodium, rutheniu