960 x 350_41

体外代谢

ADME 测定开发流程包括体外 ADME 测定,一旦选择了主要候选物,就需要进行这些分析。候选药物的安全性特征将部分取决于其与其他药物的相互作用,特别是可能伴随使用的标准治疗的药物。因此,使用经验证的生物分析方法评估可能的药物相互作用风险是候选物开发过程中的重要早期步骤。Q2 Solutions 提供一组体外测定以支持药物间相互作用检测,包括细胞色素 P450(CYP)酶抑制(IC50)、时间依赖性 CYP 抑制、CYP 酶诱导和 CYP 反应表型分析。所有体外代谢测定结果均以 QC 审查、监管风格报告的形式呈现,以支持 IND 申请的申报。

评估药物间相互作用风险

药物相互作用检测对这些风险进行了明确的评估,该检测应在选择主要候选物后尽早进行

Q2-Header_1280x350_2

相关思想领袖见解


Validation of a Stem Cell Assay Used as a Key Efficacy Marker for FDA Approval

Presented at CYTO 2024, the 37th annual Congress of the International Society for the Advancement of Cytometry, May 5-8, 2024 The recent announcement by BiolineRx of the FDA approval of APHEXDA™...

Spectral Cytometry; a Robust Platform for Immune Monitoring and Biomarker Discovery in Clinical Trials

By Megan McCausland - Scientific Advisor, Flow Cytometry, Biomarker and Translational Science LaboratoryPresented at CYTO 2024, the 37th annual Congress of the International Society for the...

A new ELISpot/FluoroSpot best practice using a novel lyophilized FBS for clinical immune monitoring assays

Interferon gamma (IFN) ELISpot and FluoroSpot are widely used immune monitoring assays to detect functional cell responses in clinical studies. Recognized for their importance in vaccine development...