期刊
THERAPEUTIC DRUG MONITORING
卷 27, 期 5, 页码 617-624出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/01.ftd.0000170879.18139.40
关键词
stability; drug testing
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据