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Bioanalytical method validation: An updated review

Submitted by webadmin on Thu, 10/13/2016 - 17:19
Pharmaceutical Methods,2010,1,1,25-38.
Published:October 2010
Type:Review Article

Bioanalytical method validation: An updated review

Gaurav Tiwari, Ruchi Tiwari

Department of Pharmaceutics, Pranveer Singh Institute of Technology, Kalpi Road, Bhauti, Kanpur - 208 020, Uttar Pradesh, India


The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development, culminating in a marketing approval. The objective of this paper is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic (PK), toxicokinetic, bioavailability, and bioequivalence studies. Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fluids, plays a significant role in the evaluation and interpretation of bioequivalence, PK, and toxicokinetic studies. Selective and sensitive analytical methods for quantitative evaluation of drugs and their metabolites are critical for the successful conduct of pre-clinical and/or biopharmaceutics and clinical pharmacology studies.