Metabolite Identification (MetID)
分析和鉴定代谢物是支持药物发现和新化合物的发展的关键步骤。代谢物鉴定(MOTID)研究有助于您了解清除机制,解析潜在的活性或反应性代谢物的存在,并观察化合物中的不成比例或独特的代谢物,以更好地理解您的分子的生物转化能力。
Nonclinical Metabolite Identification
- Soft spot identification
- 体外交叉物种比较
- Preclinical AME/ADME
Clinical Metabolite Identification
- 人类艾美
- Clinical metabolite identification
- In vivo cross species comparison
环境代谢物鉴定研究
- Agro chemical metabolite identification
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- Gain early comparative, cross-species information to support MIST, ICH M3 and EMA/FDA DDI guidelines, including correct selection of preclinical tox species
- 使有针对性的修改改变间隙性质
- Mitigate risk associated potential drug-drug interactions
- 减少反应性代谢物
- 识别早期可能独特或不成比例的人类代谢物
MetID Technology
MetID的互补技术
- Matrix Matching:减少矩阵通过匹配物种匹配矩阵来促进物种之间代谢物反应的比较。
- 氘交易所:Characterize metabolites by using deuterated mobile phase to highlight exchangeable protons such as –NH, -OH and –COOH. Supports structural elucidation and differentiation of isomeric metabolites.
- 三氯化钛:通过使用氯化钛(III)氯化物来证实N-氧化物以减少胺。
- Metabolite isolation: Isolate specific metabolites to facilitate identification.
- 酶欺诈孵育酶,通常用β-葡糖醛酸酶(EX Helix PoMatia),以释放代谢物释放糖苷酮,提供有关所提出的代谢物的其他信息。更具体的酶可用于检查诸如硫酸盐或葡糖醛酸等特异性缀合物。
- TLC.: Gain a secondary method for confirmation using an alternative chromatography method. Can be run in 1 or 2 dimensions, manually or through an automated plate spotter.
Common Biologics Studies
- Oligonucleotides- 可能的寡核苷酸类型:单链,双链,siRNA,非天然修饰,靶向结构,改性磷酸糖
- Peptide- Synthetic or modified peptides (usually 10-15 amino acids). Radiolabel usually required.
- Antibody drug conjugates- 体外经验,临床前的Adme。yaboapp体育官网通常调查给弹头的代谢或弹头和接头。
Met ID Studies & Regulatory Guidance
在整个药物或设备开发连续体中发生代谢物鉴定研究。这些研究生成的数据支持DMPK研究的以下监管指南:
- ICHM3对人类临床试验进行的非临床安全研究指导
- Marketing Authorization for Pharmaceuticals (2008)
- FDA Safety Testing of Drug Metabolites Guidance for Industry (2016)
- EMA DDI.