Bioanalytical Method Validation

Bioanalytical Method Validation

Bio-Products Validation Technique

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The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval.Bioanalytical method validation (BMV) employed for the quantitative determination of drugs and their metabolites in biological fluids plays a significant role in the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic study data. These studies generally support regulatory filings. It has been adopted universally as a standard procedure for validating bioanalytical assays used for pha...