A SHORT REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Tanniru Rajeswari* and Dr. Hariom Sharma

ABSTRACT

This paper's review examines the practices relevant to pharmaceutical preparation within biological matrices and aims to deliver practical tactics for the analysis of selectivity, specificity, detection limits, low quantitation thresholds, linearity, range, accuracy, precision, recovery, stability, resilience, and robustness of liquid chromatography techniques to assist pharmacokinetic (PK), toxicokinetic, bioavailability, and bioequivalence assessments. Bioanalysis, utilized for the quantitative assessment of pharmaceuticals and their metabolites in biological fluids, holds a pivotal position in the appraisal and elucidation of bioequivalence, PK, and toxicokinetic assessments. Developing precise and nuanced methods for quantitatively assessing medications and their breakdown products is vital for successfully conducting both preclinical and clinical pharmacology studies, including biopharmaceutical research.

Keywords: Bioanalytical method, Plasma, validation, ICH Guidelines.