Final FDA Guidance on Bioanalytical Method Validation

The U.S. Food and Drug Administration released a final guidance to provide recommendations for the development, validation and in-study use of bio analytical methods.  This guidance is intended for Sponsor organizations and may be helpful for bioanalytical methods used in human clinical pharmacology, bioavailability and bioequivalence studies and aid the development of bio analytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data.  The full guidance may be downloaded here.