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Regulatory Guidance Documents

FDA Guidance Bioanalytical Method Validation, May 2001

Recommendations for the Bioanalytical Method Validation of Ligand Building Assays to support Phamacokinetic Assessments of Macromolecules, Nov. 2003

Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays, Feb 2007

Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement, July 2006

FDA Guidance on Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, April 2008

FDA Guidance Draft Drug Interaction Studies, Sept. 2006

The Conduct of In Vitro and In Vivo Drug-Drug Interaction Studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) Perspective, July 2003

FDA Guidance For Industry: Safety Testing of Drug Metabolites, Feb. 2008

 

 

 

 

 
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