美国FDA 指导原则 宠物药物应用.NDA和ANDA附件的内容和格式I化学、制造和控制(CMC)章节的样本格式_2011 英文原版.pdfVIP

Draft — Not for implementation Attachment I Sample Formats— Chemistry, Manufacturing, and Controls (CMC) Section Ammonia N 13 Injection Fludeoxyglucose F 18 Injection (FDG F 18) and Sodium Fluoride F 18 Injection Date: August 2011 These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET