供試品的檢測(cè)與分析是保證藥物非臨床安全性評(píng)價(jià)結(jié)果可靠性的關(guān)鍵性因素。本文從藥物安全性評(píng)價(jià)中供試品的含量檢測(cè)方法驗(yàn)證、取樣分析、含量準(zhǔn)確性分析、穩(wěn)定性分析、均勻性分析、分析結(jié)果和超標(biāo)準(zhǔn)結(jié)果的處理、剩余樣品的處理等方面進(jìn)行了討論,并提出作者的看法。

The detection and analysis of test samples are key factors to ensure the dependability of nonclinical safety evaluation. This paper comprehensively discussed the practices of analysis on the test samples including method validation for formulation, sample, concentration, stability, homogeneity, interpretation of results, OOS results, and disposition of excess sample.