创新药物转化研究中ADME的评价

新药研发是一复杂的庞大系统工程, 所涉及的学科门类众多, 研究周期长。而转化研究有助于构建创新药物的基础研究、临床前研究和临床疗效评价直至新药制造和临床应用的系统研发链, 顺畅基础医学和生物学与创新药物研发、临床医学之间的信息和研究关联, 缩短创新药物从实验室到临床应用的研发周期。在新药研发和临床应用过程中, 化合物的体内过程 (吸收、分布、代谢、排泄, ADME) 是其成药性的重要指标。化合物ADME/T性质在创新药物转化研究中发挥重要作用并贯穿研发过程。因此, 在药物设计及新药开发早期就开展药物代谢研究, 有利于提高新药研发的成功率, 降低新药开发的成本, 获得安全、有效的治疗药物。

The role of ADME evaluation in translation research of innovative drug

New Chemical Entities (NCEs) development is a systematic long-term project that involves multiple disciplines.  The translation research will help to build an advanced R&D system from the basic laboratory   research, preclinical studies and clinical evaluation to clinical application of drug, for the purpose of shortening the R&D cycle and accelerate the launch of new drugs.  In new drug R&D and its clinical application, drug disposition (absorption, distribution, metabolism, excretion, ADME) properties are important criteria for assessing drug-likeness of candidates.  ADME evaluation of NCEs plays an important role in the translation research throughout innovative drug R&D process.  Therefore, ADME evaluation at the early stage of drug design and development will be helpful to improve the success rate and reduce costs, and further access to safe, effective drugs.