Concepedia

Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Steve Lowes, Jim Jersey, Ronald E. Shoup, Fabio Garofolo, Natasha Savoie, Shane Needham, Maria Cruz Caturla, Ray Steffen, Curtis Sheldon, Tim Samuels,

Bioanalysis · 2011 · 88 citations · 7 references

DOI

Concepts

Abstract

"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

References

7

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay et al. · Pharmaceutical Research · 2000 · 1.6K citations

, , +11

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

C.T. Viswanathan, Surendra K. Bansal, Brian Booth et al. · Pharmaceutical Research · 2007 · 815 citations

, , +16

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

C.T. Viswanathan, Surendra K. Bansal, Brian Booth et al. · The AAPS Journal · 2007 · 483 citations · Full text

, , +13

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

Natasha Savoie, Fabio Garofolo, Peter van Amsterdam et al. · Bioanalysis · 2010 · 122 citations

, , +15

The 2nd Calibration and Validation Group Workshop on Recent Issues in Good Laboratory Practice Bioanalysis

Natasha Savoie, Brian Booth, T Hyman Bradley et al. · Bioanalysis · 2009 · 94 citations

, , +17