Final Guidance for Industry Bioanalytical Method Validation
The final guidance, published in May 2018, has been updated to incorporate public comments to the 2013 revised draft and to reflect scientific and technological advances in the validation of bioanalytical methods. The guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologic license applications (BLAs). The guidance applies to bioanalytical procedures that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation when used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies.
This guidance can also be applied to the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data.
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