Abstract
Bioanalysis covers the quantitation of drugs and/or its metabolites in biological matrices. The analytical methods used for bioanalysis are often referred to as bioanalytical methods. Bioanalytical methods are routinely used for quantitative determination in bioequivalence, pharmacokinetic, and toxicokinetic studies to generate exposure data. Hence, the quality of data in such studies is directly related to the quality of the underlying bioanalysis. It is therefore imperative that the bioanalytical assays used in the above studies are sufficiently robust for their intended use. Consequently, regulatory agencies, such as the United States’ Food and Drug Administration, have issued guidelines for validation and use of bioanalytical methods intended for regulatory submissions. Further, over the years, divergent bioanalytical tools and techniques have evolved, and significant scientific and regulatory experience has been gained. This chapter addresses the current best practices in bioanalytical method validation and conduct, discusses recent developments in bioanalysis, and highlights the challenges in bioanalysis.
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Notes
- 1.
This draft guidance is not for implementation. Since the draft guidance is issued for public review and comment, the recommendations in the guidance may be modified when finalized.
- 2.
Samples collected from an animal or human dosed with drugs during drug development.
- 3.
The accuracy of an analytical method describes the closeness of mean test results obtained by the method to the actual concentration of the analyte. The precision (or imprecision) of an analytical method describes the random error of measurement, i.e., dispersion of the results around average value, often expressed as relative standard deviation (RS) or coefficient of variation (CV).
- 4.
Sum of absolute values of % accuracy and % precision.
- 5.
The extraction efficiency of an analytical process, reported as a percentage of the known amount of an analyte carried through the sample extraction and processing steps of the method.
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Acknowledgments
The author thanks Drs. Brian P. Booth, Ethan M. Stier, Robert Lionberger, and Yongsheng Yang for their critical review of the manuscript.
DisclaimerThe chapter reflects the views of the author and should not be construed to represent FDA’s views or policies. No official endorsement by the FDA is intended or should be inferred.
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Subramaniam, S. (2014). Bioanalysis. In: Yu, L., Li, B. (eds) FDA Bioequivalence Standards. AAPS Advances in the Pharmaceutical Sciences Series, vol 13. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1252-0_16
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