1.1. Packaging and numbering of study IMP
进行研究时试验用药品(IMP)的包装和编号
Packaging and distribution of IMP will be conducted by LC2 for all sites.
采用LC2对所有地点进行试验用药品的包装和发运。
The IMP will be supplied as 100 mg and 200 mg non-divisible capsule-shaped orange coated tablets, packaged in polyethylene bottles. Tablets are packaged by 30 units, with a tear-off part of the label to be removed by the investigator or the pharmacist when providing the IMP to the patient and to be attached in the respective section of the IMP dispensation form. Dispensed IMP number will be reported in the eCRF.
试验用药品供应形式为剂量100mg和200mg的不可分胶囊状橙色包衣片,采用聚乙烯药瓶包装。片剂以30单位进行包装。标签带有可撕掉的部分,研究者或药师在对患者进行给药时撕掉这部分标签粘贴到试验用药品给药形式的相应部分。所分配的试验用药品编号应在eCRF中有记录。
The allocation of masitinib bottles to patient is performed via IWRS. The IWRS User Guide outlines the protocol for site staff, pharmacist and CRA for the respective roles of initial shipment reques
进行研究时试验用药品(IMP)的包装和编号
Packaging and distribution of IMP will be conducted by LC2 for all sites.
采用LC2对所有地点进行试验用药品的包装和发运。
The IMP will be supplied as 100 mg and 200 mg non-divisible capsule-shaped orange coated tablets, packaged in polyethylene bottles. Tablets are packaged by 30 units, with a tear-off part of the label to be removed by the investigator or the pharmacist when providing the IMP to the patient and to be attached in the respective section of the IMP dispensation form. Dispensed IMP number will be reported in the eCRF.
试验用药品供应形式为剂量100mg和200mg的不可分胶囊状橙色包衣片,采用聚乙烯药瓶包装。片剂以30单位进行包装。标签带有可撕掉的部分,研究者或药师在对患者进行给药时撕掉这部分标签粘贴到试验用药品给药形式的相应部分。所分配的试验用药品编号应在eCRF中有记录。
The allocation of masitinib bottles to patient is performed via IWRS. The IWRS User Guide outlines the protocol for site staff, pharmacist and CRA for the respective roles of initial shipment reques
