A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Tijare LK; Rangari Nt; Mahajan Un

doi:10.22159/ajpcr.2016.v9s3.14321

Authors

Tijare LK Research student
Rangari Nt
Mahajan Un

DOI:

https://doi.org/10.22159/ajpcr.2016.v9s3.14321

Abstract

ABSTRACT
In this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should be
applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their
metabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic
studies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigated
to decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of set
up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass
spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic
methods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy,
precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed
to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug,
concentration and its metabolite.
Keywords: Method development, Clinical and nonclinical study, Analyte, Validation of bioanlysis techniques, Validation parameter.

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Author Biography

Tijare LK, Research student

Department of Quality Assurance

References

Thompson M, Ellison SL, Wood R. Harmonized guidelines for single laboratory validation of method of analysis. Pure Appl Chem 2008;74(5):835-55.

Wood R. How to validate analytical methods. Trends Analyt Chem 2005;18:624-32.

Chiu ML, Lawi W, Snyder ST, Wong PK, Liao JC, Gau V. Matrix effects: A challenge toward automation of molecular analysis. J Assoc Lab Autom 2010;15:233-42.

Reid E, Wilson ID. Methodological survey in biochemistry and analysis. Analysis for Drug and Metabolites, Including Anti-Infective Agents. Vol. 20. Cambridge, England: Royal Society of Chemistry; 1990. p. 1-57.

Surendra B, DeStefano A. Key elements of bioanalytical method validation for small molecules. AAPS J 2007;9(1):109-14.

McDowall RD. The role of laboratory information management systems LIMS in analytical method validation. Anal Chim Acta 2007;54:149-58.

Vander Heyden Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste BG, Massart DL. Guidance for robustness/ruggedness tests in method validation. J Pharm Biomed Anal 2001;24(5-6):723-53.

Puluido A, Ruusanches I, Boque R, Rius FX. Uncertainty of results in routine qualitative analysis in analytical chemistry. J Pharm Biomed Anal 2005;22:647-54.

Kallner A. Quality specifications based on the uncertainty of measurement. Scand J Clin Lab Invest 1999;59(7):513-6.

Rao KR, Kumar KS. Bioanalytical method validation-A quality assurance auditor view point. J Pharm Sci Res 2009;1(3):1-10.

Lang JR, Bolton S. A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--1. Experimental considerations. J Pharm Biomed Anal 1991;9(5):357-61.

Causon R. Validation of chromatographic methods in biomedical analysis. Viewpoint and discussion. J Chromatogr B Biomed Sci Appl 1997;689(1):175-80.

Shah VP. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical method validation. AAPS J 2007;9(1):43-7.

Buick AR, Doig MV, Jeal SC, Land GS, McDowall RD. Method validation in the bioanalytical laboratory. J Pharm Biomed Anal 1990;8(8-12):629-37.

Tiwari G, Tiwari R. Bioanalytical method validation: An updated review. Pharm Methods 2010;1(1):25-38.

Jhang JS, Chang CC, Fink DJ, Kroll MH. Evaluation of linearity in the clinical laboratory. Arch Pathol Lab Med 2004;128(1):44-8.

Mark H. Application of improved procedure for testing linearity of analytical method to pharmaceutical analsysis. J Pharm Biomed Anal 2003;33(1):7-20.

Hartmann C, Smeyers-Verbeke J, Massart DL, McDowall RD. Validation of bioanalytical chromatographic methods. J Pharm Biomed Anal 1998;17(2):193-218.

Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. Vol. 13. Rockville, MD: U.S Department of Health and Human Services, Food and Drug Administration; 2001. p. 385-94.

Wells DA. High throughput bioanalytical sample preparation: Methods and automation strategies. Progress in Pharmaceutical and Biomedical Analysis. Vol. 30. Amsterdam, London: Elsevier; 2003. p. 610.

Karnes HT, Shiu G, Shah VP. Validation of bioanalytical methods. Pharm Res 1991;8(4):421-6.

Kringle RO. An assessment of the 4-6-20 rule of acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. Pharm Res 1994;11(4):556-60.

Wieling J, Hendriks G, Tamminga WJ, Hempenius J, Mensink CK, Oosterhuis B, et al. Rational experimental design for bioanalytical methods validation. Illustration using an assay method for total captopril in plasma. J Chromatogr A 1996;730(1-2):381-94.

Kringle R, Hoffman D. Stability methods for assessing stability of compounds in whole blood for clinical bioanalysis. Drug Inf J 2001;35:1261-70.

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. AAPS J 2007;9(2):E260-7.

Singh PS, Shah G. Analytical method development and validation. J Pharm Res 2011;4(5):2330-2.

Dadgar D, Burnett PE. Issues in evaluation of bioanalytical method selectivity and drug stability. J Pharm Biomed Anal 1995;14(1-2):23-31.

Miller KJ, Bowsher RR, Celniker A, Gibbons J, Gupta S, Lee JW, et al. Workshop on bioanalytical methods validation for macromolecules: Summary report. Pharm Res 2001;18(9):1373-83.

Hubert H, Chiap P, Crommen J, Boulanger B, Chapuzet E, Mercier N, et al. The SFSTP guide on the validation of chromatographic methods for drug analysis: From the Washington Conference to the laboratory. Anal Chim Acta 1999;391:45-55.

Timm U, Wall M, Dell D. A new approach for dealing with the stability of drugs in biological fluids. J Pharm Sci 1985;74(9):972-7.

Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J 2007;9(2):E117-22.

Braggio S, Barnaby RJ, Grossi P, Cugola M. A strategy for validation of bioanalytical methods. J Pharm Biomed Anal 1996;14(4):375-88.

James CA, Breda M, Frigerio E. Bioanalytical method validation: Arisk-based approach? J Pharm Biomed Anal 2004;35(4):887-93.

Boulanger B, Chiap P, Dewe W, Crommen J, Hubert P. An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: Progresses and limitations. J Pharm Biomed Anal 2005;32(4-5):753-65.