Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Bioanalytical Method Validation.” This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
Scope & Applicability
Product Classes
1Recommendations for when commercial diagnostic kits are repurposed as analytical methods.
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10Ability to differentiate analyte in presence of matrix components
Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
A component of precision validation; Reproducibility is assessed by means of an interlaboratory trial
Should be studied as part of the investigation of stability
Must be demonstrated if macromolecules are frozen overnight
The sum of the absolute value of the errors in accuracy and precision
Impact of carryover on the accuracy of study sample concentrations
A physiological property that can contribute to analytical error in glucose monitoring.; High altitude can result in changes to hematocrit.
Parallelism should be evaluated for assays for endogenous compounds.
Upper Limit of Quantitation used for dilution integrity monitoring
Identified Hazards
Hazards
3Alteration or interference in response because of unintended analytes
Increasing analyte concentrations result in no change or decreased signals
Impact during study sample analysis should be assessed and reported
Related CFR Sections (1)
- 21CFR320.29§ 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
(a) The analytical method used in an in vivo bioavailability or bioequivalence study to measure the concentration of the active drug ingredient or therapeutic moiety, or its active metabolite(s), in body fluids or excretory products, or the method used to measure an acute pharmacological effect shalRead full regulation →
See Also (5)
- Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry (Status: Final)
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (Status: Draft)
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Status: Final)