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Asian Journal of Research in Pharmaceutical Science
Year : 2018, Volume : 8, Issue : 2
First page : ( 107) Last page : ( 114)
Print ISSN : 2231-5640. Online ISSN : 2231-5659.
Article DOI : 10.5958/2231-5659.2018.00019.X

Bioanalytical Method Validation: A Concise Review

Saudagar R. B.1,*, Thete P. G.2

1Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

2Department of Quality Assurance Techniques. R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, India

*Corresponding Author E-mail:

Online published on 7 July, 2018.

Abstract

Validation of bioanalytical methods includes the performance of all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix (e.g., blood, plasma, serum, or urine) is consistent and reproducible for the intended use. Validation of bioanalytical methods includes the performance of all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix (e.g., blood, plasma, serum, or urine) is consistent and reproducible for the intended use. The bioanalytical validation is divided into 3 types that are Full validation, partial validation, and cross validation. This review consist of evaluation of key parameters of bioanalytical method Accuracy, Precision, Linearity, Selectivity and specificity, Limit of detection, Limit of quantitation, Standard curve (calibration curve), Recovery, Stability, Robustness, and Ruggedness.

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Keywords

Bioanalytical method validation, Validation parameters, ICH documents.

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