Bioanalytical Method Validation: FDA Finalizes Guidance From 2013

Regulatory NewsRegulatory News | 21 May 2018 |  By 

The US Food and Drug Administration (FDA) on Monday finalized guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic or biomarker concentration evaluation.

Differences between the draft and final guidance, which is 10 pages longer, include a re-working of the text, a new title for Section III, which was previously named “Chromatographic methods” but is now “Bioanalytical method development and validation,” and new sections on parameters of chromatographic assays (CCs) and ligand binding assays (LBAs).

“This final guidance incorporates public comments to the revised draft published in 2013 and provides recommendations for the development, validation, and in-study use of bioanalytical methods,” FDA said. “The recommendations can be modified with justification, depending on the specific type of bioanalytical method. This guidance reflects advances in science and technology related to validating bioanalytical methods.”

The revision in 2013 followed an initial release of guidance in 2001. FDA explains the need for the guidance by noting that validating an analytical method ensures that data are reliable by addressing certain key questions, including:
  • “Does the method measure the intended analyte? For example, does anything interfere with the measurement, and is the method specific or selective for the analyte?
  • What is the variability associated with these measurements? For example, what are the accuracy and precision of the method?
  • What is the range in measurements that provide reliable data? For example, what is the sensitivity of the method (e.g., what is the lower limit of quantitation (LLOQ) of the method, and what is the upper limit of quantitation the method (ULOQ)?)
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method? For example, what steps need to be followed while collecting samples? Do the samples need to be frozen during shipping? What temperatures are required to store the samples, and how long can the samples be stored?”
Steve Lowes, PhD, senior director of bioanalytical services at Q2 Solutions, told Focus: “We were in need of an updated final BMV Guidance over the 2001 document. Our bioanalytical discipline has advanced tremendously since the turn of the century both in terms of technology and technique.

“Today we interrogate our bioanalytical methods that are used for safety, efficacy and labelling to a very high degree of analytical rigor,” Lowes said, stressing the need to review the entire document. “Historically, the FDA BMV Guidance has been a document that truly influences practice at the lab bench and so I look forward to fully interpreting the new Guidance language and seeing it help establish consistency and progress.”

Meanwhile, EMA’s guideline on bioanalytical method validation took effect in 2012.

Bioanalytical Method Validation: Guidance for Industry


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