Journal
THERAPEUTIC DRUG MONITORING
Volume 27, Issue 5, Pages 617-624Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/01.ftd.0000170879.18139.40
Keywords
stability; drug testing
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Stability is one of the basic parameters, along with accuracy, precision, selectivity, and sensitivity, for bioanalytic method validation in nonhuman and clinical pharmacology/toxicology, bioavailability (BA), bioequivalence (BE), and other studies related to the drug approval process. In the drug development stage where stability evaluation is obligatory, instability of drug candidates in biologic samples will seriously complicate assay validation. In this article, we review the general strategies and methodologies such as temperature adjustment, pH control, derivatization, and addition of inhibitors and oxidant that are commonly employed to stabilize pharmaceuticals that might be unstable in biologic samples.
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