A MINI REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

This review emphasizes the effectiveness of bioanalytical techniques in pharmacokinetic, pharmacodynamics, and toxicological evaluations, highlighting their essential role in drug development. The quantitative assessment of pharmaceuticals, metabolites, and endogenous chemicals in biological matrices such blood, plasma, urine, and cerebrospinal fluid was the focus of a thorough examination of bioanalysis procedures. Sample collection, preparation, analysis, and reporting are among the essential processes in the bioanalytical process that are described in the review. Particular focus is placed on the phases of method development, from pre-validation to literature evaluation, as well as sample preparation methods such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. Method validation procedures were based on international norms like ICH Q2 and M10. The outcomes show that data correctness, precision, selectivity, and dependability are guaranteed by established bioanalytical techniques. Different stages of drug development require different forms of validation, such as cross-, partial, and full validation. Effective method validation is essential for both clinical monitoring and medication approval because it reduces variability and promotes regulatory compliance. For drug development initiatives to be successful, reliable bioanalytical methods must be established and validated. Following internationally accepted validation guidelines guarantees high-quality data, allowing for well-informed choices to be made throughout therapeutic evaluation and regulatory filing. The significance of scientifically competent bioanalytical methods in producing trustworthy data for drug safety and efficacy evaluations is emphasized by this review.