Guidance Documents: Download Pharmaceutical Guidance Documents Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Bioanalysis: FDA Guidance Bioanalytical Method Validation, May 2001 Recommendations for the Bioanalytical method Validation of Ligand Building Assays to support Pharmacokinetic Assessments of Macromolecules, Nov. 2003 Workshop/conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays, Feb 2007 Key Elements of Bioanalytical Method Validation for Small Molecules, 2007 Biomarkers/Translational Medicine: 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 DMPK: 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 Draft Drug Interaction Studies, Sept. 2006 FDA Guidance for Industry: Safety Testing of Drug Metabolites, Feb. 2008 ADME studies in animals and humans: Experimental design, metabolite profiling and identification, and data presentation, 2008 Human Radiolabeled Mass Balance Studies: Objectives, Utilities and Limitations, 2009 Early Clinical Research: FDA Guidance For Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, Oct. 2005 GMP: Guidance for Industry CGMP for Phase 1 Investigational Drugs, July 2008