生物等效性
药品
药理学
药物开发
生物利用度
衍生化
生化工程
计算生物学
化学
色谱法
医学
生物
高效液相色谱法
工程类
作者
Jiwen Chen,Yunsheng Hsieh
标识
DOI:10.1097/01.ftd.0000170879.18139.40
摘要
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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