Stabilizing drug molecules in biological samples.
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.
Chen
Jiwen
J
Drug Metabolism and Pharmacokinetics Department, Schering-Plough Research Institute, Kenilworth, New Jersey 07033, USA.
Hsieh
Yunsheng
Y
D000818:Animals; D000975:Antioxidants / Q000494:pharmacology; D004355:Drug Stability; D004791:Enzyme Inhibitors / Q000494:pharmacology; D000882:Haplorhini; D006801:Humans; D006863:Hydrogen-Ion Concentration; D051379:Mice; D004364:Pharmaceutical Preparations / Q000097:blood* / Q000652:urine; D051381:Rats; D013696:Temperature
D000975:Antioxidants; D004791:Enzyme Inhibitors; D004364:Pharmaceutical Preparations