Bioanalysis Zone

FDA releases draft of bioanalytical method validation


New guidance for bioanalytical method validation has recently been announced by the FDA. The original guidance entitled ‘Guidance for Industry: Bioanalytical Method Validation’ was released in May 2001. Significant scientific and technological advancements over the last decade have made it necessary for the FDA to revise the guidance accordingly.

The document outlines six fundamental parameters for ensuring adequate method development and validation: accuracy, precision, selectivity, sensitivity, reproducibility and stability. These are particularly important for obtaining data that provides sound support for drug and biologic development studies.

Some of the revisions that reflect advancements in the field include the addition of new sections on endogenous compounds, biomarker assays, and the use of diagnostic kits. The FDA has also updated pre-existing sections including ligand binding assays, and chromatographic methods.

The draft guidance document is being distributed for comment purposes only, and the FDA has encouraged the public to submit their written or electronic feedback by December 12th 2013. The document notes that the guidance provided describes the FDA’s current thinking on the topic, and does not establish legally enforceable responsibilities, unless specific regulatory or statutory requirements are cited.

Responding to the release of the draft guidance, the European Bioanalysis Forum Organizing Committee have announced that they will devote a session of the 6th Open Symposium in November to the discussion. An announcement is expected soon for a fifth Crystal City meeting in the US.

The guidance has also attracted attention on our Forum. Peter van Amsterdam “Immediately noted the difference between ‘FDA ISR’: 7% and ‘EMA ISR’: 10% + 5% >1000”, while JamesLawrence had concerns about the LBA section and felt it was “rather vague about determining matrix effects.”

Let us know what you think – join the discussion in the Forum.

Source: Guidance for industry: bioanalytical method validation; Draft guidance for industry on bioanalytical method validation; availability.


Leave A Comment