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| | 5 | The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation
Vinod P. Shah
[Full Text] [PDF] | | | 1 | Dual Dopamine/Serotonin Releasers as Potential Medications for Stimulant and Alcohol Addictions
Richard B. Rothman, Bruce E. Blough, Michael H. Baumann
[Abstract] [Full Text] [PDF] | | 2 | Vectors for Airway Gene Delivery
Pamela B. Davis, Mark J. Cooper
[Abstract] [Full Text] [PDF] | | 3 | Peptide-guided Gene Delivery
Molly E. Martin, Kevin G. Rice
[Abstract] [Full Text] [PDF] | | 7 | A Survey of Population Analysis Methods and Software for Complex Pharmacokinetic and Pharmacodynamic Models with Examples
Robert J. Bauer, Serge Guzy, Chee Ng
[Abstract] [Full Text] [PDF] | | 8 | Informatics: The Fuel For Pharmacometric Analysis
Thaddeus H. Grasela, Jill Fiedler-Kelly, Brenda Cirincione, Darcy Hitchcock, Kathleen Reitz, Susanne Sardella, Barry Smith
[Abstract] [Full Text] [PDF] | | 9 | Nonviral Gene Delivery: What We Know and What Is Next
Xiang Gao, Keun-Sik Kim, Dexi Liu
[Abstract] [Full Text] [PDF] | | 11 | Key Elements of Bioanalytical Method Validation for Small Molecules
Surendra Bansal, Anthony DeStefano
[Abstract] [Full Text] [PDF] | | | 10 | Biomarker Qualification Pilot Process at the US Food and Drug Administration
Federico Goodsaid, Felix Frueh
[Full Text] [PDF] | | | 4 | Workshop/Conference Report — Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
C. T. Viswanathan, Surendra Bansal, Brian Booth, Anthony J. DeStefano, Mark J. Rose, Jeffrey Sailstad, Vinod P. Shah, Jerome P. Skelly, Patrick G. Swann, Russell Weiner
[Full Text] [PDF] | | 6 | AAPS-FDA Workshop White Paper: Microdialysis Principles, Application, and Regulatory Perspectives Report From the Joint AAPS-FDA Workshop, November 4-5, 2005, Nashville, TN
Chandra S. Chaurasia, Markus Müller, Edward D. Bashaw, Eva Benfeldt, Jan Bolinder, Ross Bullock, Peter M. Bungay, Elizabeth C.M. DeLange, Hartmut Derendorf, William F. Elmquist, Margareta Hammarlund-Udenaes, Christian Joukhadar, Dean L. Kellogg, Craig E. Lunte, Carl Henrik Nordstrom, Hans Rollema, Ronald J. Sawchuk, Belinda W.Y. Cheung, Vinod P. Shah, Lars Stahle, Urban Ungerstedt, Devin F. Welty, Helen Yeo
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