基于药物溶解性和渗透性测定的生物药剂分类系统在兽药制剂研发的应用前景

Application prospect of biopharmaceutical classification system based on drug solubility and permeability determination in veterinary drug development

生物药剂分类系统(BCS)是基于药物溶解性和渗透性测定的药物分类预测系统,目前被FDA、WHO、EMA等权威机构认可并应用于人用药物豁免其体内生物等效性研究。鉴于兽药研发成本及利润等问题,将BCS概念应用于兽药制剂研发领域,势在必行。但是人与动物在解剖、生理学等方面以及在临床使用的药物种类上均存在较大差异,故不能进行直接的种间外推,尚待深入研究以解决局限性和方法问题,才能付诸应用。尽管如此,美国药典专家委员会的特别委员会已经建议将BCS应用于犬,此举无疑具有典范作用和重要的现实意义。

Biopharmaceutical classification system（BCS） is one of the most significant prognostic tools based on drug solubility and permeability.Currently,FDA,WHO and EMA have approved it to be applied as a science-based approach for the waiver of in vivo bioavailability and bioequivalence testing of the drugs used in human medicine.It is imperative to apply BCS to the development of novel veterinary drugs in view of the cost.However,the extrapolation of human criteria to veterinary species is not straightforward due to the difference in anatomy,physiology and types of drugs used in clinic between man and animals.The predictive system must be supported by further studies regarding the limitation and methodology between humans and animals.Nevertheless,the Special Committee of the American Pharmacopoeia Commission has recommended that BCS be applied to dogs,which is undoubtedly a good model and has profound significance.