Volume No. :   8

Issue No. :  2

Year :  2018

ISSN Print :  2231-5640

ISSN Online :  2231-5659


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Bioanalytical Method Validation: A Concise Review



Address:   R. B. Saudagar1*, P. G. Thete2
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
DOI No: 10.5958/2231-5659.2018.00019.X

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.
KEYWORDS:
Bioanalytical method validation, Validation parameters, ICH documents.
Cite:
R. B. Saudagar, P. G. Thete. Bioanalytical Method Validation: A Concise Review. Asian J. Res. Pharm. Sci. 2018; 8(2):107-114.
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