Bioanalytical Method Development and Validation

Bioanalytical method development and validation involve designing, optimizing, and confirming analytical techniques to accurately quantify drugs, metabolites, and biomarkers in biological samples. This process ensures reliability and reproducibility for pharmacokinetic, toxicokinetic, and clinical studies. Key aspects include sensitivity, specificity, accuracy, precision, and stability. Robust validation follows regulatory guidelines, enabling confident decision-making in drug development, therapeutic monitoring, and biomedical research.

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