抗体偶联药物(Antibody Drug Conjugate,ADC),是通过连接子将高细胞毒性化合物连接到靶向肿瘤抗原的抗体上,利用抗体靶向识别将化合物递呈至肿瘤细胞表面,杀死肿瘤细胞。ADC药物同时具有抗体和化学药物属性,是将两者的优势结合,极大地...抗体偶联药物(Antibody Drug Conjugate,ADC),是通过连接子将高细胞毒性化合物连接到靶向肿瘤抗原的抗体上,利用抗体靶向识别将化合物递呈至肿瘤细胞表面,杀死肿瘤细胞。ADC药物同时具有抗体和化学药物属性,是将两者的优势结合,极大地提高了药物安全有效性。ADC药物结构复杂,在抗原识别表位、连接位点、连接子以及小分子药物各组分均存在特异性,所以在开展安全性评价研究时有一定的特殊性。本文将从动物种属选择、一般毒性研究、毒代动力学研究、组织交叉反应、免疫原性检测、安全药理研究、遗传毒性研究等方面,阐述ADC药物临床前安全性评价的考虑要点和研究策略。展开更多
Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and...Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and planning for success are key actions for all investigators to ensure a study is ro- bust and suitable for submission and regulatory acceptance. This presentation will examine an area of study conduct which can be problematic but which if approached correctly will ensure good study conduct. Many test materials under develop- ment today are insoluble. Achieving a suitable formulation for administration to laboratory animalsis difficult and therefore having strategies for determining suitable vehicles and dosing regimen essential. To achieve the optimal bioavailability of the chemical you need to strike a balance between the dose concentration, dose volume and the dosing regimen. The presentation will consider the interactions of factors such as the physical nature of the final formulation, physicalproperties of vehicles and potential side effects which should be considered together when optimising the final dosing formulation. It will demonstrate how a methodical approach can assist the scientist in establishing a formulation that will achieve the best bioavailability possible with minimal effects to the test animal. The presentation will also illustrate how the Study Director can demonstrate strong involvement and active study management as required by the GLP authorities.展开更多
文摘抗体偶联药物(Antibody Drug Conjugate,ADC),是通过连接子将高细胞毒性化合物连接到靶向肿瘤抗原的抗体上,利用抗体靶向识别将化合物递呈至肿瘤细胞表面,杀死肿瘤细胞。ADC药物同时具有抗体和化学药物属性,是将两者的优势结合,极大地提高了药物安全有效性。ADC药物结构复杂,在抗原识别表位、连接位点、连接子以及小分子药物各组分均存在特异性,所以在开展安全性评价研究时有一定的特殊性。本文将从动物种属选择、一般毒性研究、毒代动力学研究、组织交叉反应、免疫原性检测、安全药理研究、遗传毒性研究等方面,阐述ADC药物临床前安全性评价的考虑要点和研究策略。
文摘Practical problems in regulatory toxicology I ：Formulations
Although highly regulated, all non-clinical toxicology studies have the potential to experience practical prob- lems. Anticipation of potential hurdles and planning for success are key actions for all investigators to ensure a study is ro- bust and suitable for submission and regulatory acceptance. This presentation will examine an area of study conduct which can be problematic but which if approached correctly will ensure good study conduct. Many test materials under develop- ment today are insoluble. Achieving a suitable formulation for administration to laboratory animalsis difficult and therefore having strategies for determining suitable vehicles and dosing regimen essential. To achieve the optimal bioavailability of the chemical you need to strike a balance between the dose concentration, dose volume and the dosing regimen. The presentation will consider the interactions of factors such as the physical nature of the final formulation, physicalproperties of vehicles and potential side effects which should be considered together when optimising the final dosing formulation. It will demonstrate how a methodical approach can assist the scientist in establishing a formulation that will achieve the best bioavailability possible with minimal effects to the test animal. The presentation will also illustrate how the Study Director can demonstrate strong involvement and active study management as required by the GLP authorities.
