This guidance helps sponsors of investigational new drug applications (INDs) and applicants
of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA
supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate
bioanalytical methods used to evaluate biomarker concentrations.
This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker
concentrations in nonclinical study samples.
The recommendations in this guidance pertain only to the validation of bioanalytical assays to measure in vivo biomarker concentrations in biological matrices such as blood or urine. This guidance does not apply to bioanalytical method validations for the measurement of veterinary drug concentrations or veterinary biomarker concentrations.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.