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Bioanalytical Method Validation (Paperback)
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Bioanalytical Method Validation (Paperback)
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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 pharmacokinetic, bioavailability, and
bioequivalence studies intended for regulatory submission.The
objective of this BMV 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, toxicokinetic,
bioavailability, and bioequivalence studies.
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