Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Sam A Haidar"'
Publikováno v:
Bioanalysis. 11:1823-1834
Aim: Contract research organizations and pharmaceutical firms have performed stability testing using one of two methods: storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and anal
Autor:
Sam H. Haidar
Publikováno v:
Bioanalysis. 11:583-586
Autor:
Kara A Scheibner, Sam H. Haidar
Publikováno v:
Bioanalysis. 8:999-1002
During January 2015, several offices within the Center for Drug Evaluation and Research (CDER) were re-organized to improve consistency of decision-making, and to streamline policy, procedures and communications. Some Divisions were elevated to Offic
Autor:
Xinyuan Zhang, Maureen A. Kane, Thomas C. Dowling, Stephen W. Hoag, C. Avon, Soundarya Vaithianathan, Mark Flasar, Tricia Y. Ting, James E. Polli, Changxing Shao, Sam H. Haidar, Wenlei Jiang
Publikováno v:
Journal of Pharmaceutical Sciences. 105:996-1005
The objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on Biopharmaceutics Classification System (BCS) class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs acr
Autor:
Lakshmi Amaravadi, Sriram Subramaniam, Sherri Dudal, Eric Fluhler, Sam H. Haidar, Steve Lowes, Robert Nicholson, Brian Booth, Marie Rock, John Kadavil, Binodh DeSilva, Russell Weiner, Lauren Stevenson, Boris Gorovits, Michael Skelly, Eric Woolf, Mark E. Arnold
Publikováno v:
The AAPS Journal. 17:277-288
In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a
Autor:
James E. Polli, Thomas C. Dowling, C. Avon, Soundarya Vaithianathan, Tricia Y. Ting, Changxing Shao, Maureen A. Kane, Stephen W. Hoag, Xinyuan Zhang, Sam H. Haidar, Mark Flasar, Wenlei Jiang
Publikováno v:
Journal of Pharmaceutical Sciences. 105:1355-1357
We previously concluded that 12 common excipients need not be qualitatively the same and quantitatively very similar to reference for Biopharmaceutics Classification System-based biowaivers. This conclusion for regulatory relief is based upon a serie
Autor:
Joseph M. Sandro, Sam A Haidar, Reiner Wassmann, Teodoro Q. Correa, James R. Quilty, M. C. R. Alberto, Roland J. Buresh
Publikováno v:
Agricultural Water Management. 136:1-12
In lieu of the decreasing availability of water for irrigated rice, we examined two alternatives to traditional rice cultivation on puddled and saturated soil–maize and dry-seeded rice production grown with an overhead sprinkler irrigation system.
Autor:
Bing V. Li, Aida L. Sanchez, Aaron W. Sigler, Hoainhon T. Caramenico, Barbara M. Davit, Santhosh K. Pabba, Sam H. Haidar, Ethan Stier, Christina H. Lee, Dale P. Conner, Chitra Mahadevan
Publikováno v:
The AAPS Journal. 15:10-14
“For-cause” inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common reasons for
Autor:
Robert Lionberger, Donald J. Schuirmann, Devvrat T. Patel, Barbara M. Davit, Patrick E. Nwakama, Mei-Ling Chen, Christina H. Lee, Dale P. Conner, Stephanie Kim, Lawrence X. Yu, Fairouz T. Makhlouf, Sam H. Haidar
Publikováno v:
The AAPS Journal. 14:915-924
Highly variable (HV) drugs are defined as those for which within-subject variability (%CV) in bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to the
Autor:
Sam H. Haidar, Lawrence X. Yu, Barbara M. Davit, Fairouz Makhlouf, Donald J. Schuirmann, Dale P. Conner, Terry Hyslop
Publikováno v:
The AAPS Journal. 10:450-454
Various approaches for evaluating the bioequivalence (BE) of highly variable drugs (CV ≥ 30%) have been debated for many years. More recently, the FDA conducted research to evaluate one such approach: scaled average BE. A main objective of this stu