ASSIGNMENT OF BIOEQUIVALENT ALLERGY UNITS TO POLLEN EXTRACT

花粉提取物的生物等效过敏单位的分配

• 批准号: 3792301
• 负责人: P C TURKELTAUB
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3792301
• 关键词: Ambrosia; drug quality /standard; human subject; immunologic skin test; immunological substance; plant extracts; pollen

When standardized weed and grass pollen extracts were licensed they were arbitrarily assigned 100,00 AU/ml if they were equipotent to the reference. With the introduction of the ID50EAL method, Bioequivalent Allergy Units are currently assigned based on skin test potency determined in highly skin reactive rhinitis subjects. Using the ID50AEAL method, proposed FDA reference preparations of giant ragweed and Bermuda grass were evaluated clinically. In each reference the mean D50 fell between 11-12.9, indicating they should be assigned 10,000 BAU/ml rather then the 100,000 AU/ml arbitrarily assigned. The Bermuda grass reference was also evaluated in another region of the U.S. to determine whether the CBER estimate was replaceble. When sugjects equal in reactivity were selected in Nashville, no significant difference with the Nashville D50 estimate with respect to the CBERmuda D50 estimate was found confirming the assignment of 10,000 BAU/ml to the Bermuda reference. When standardized short ragweed extracts were licensed and labelled in Allergy Units, they were arbitrarily assigned 100,000 AU/ml, if they contained between 200 to 400 Amb a 1 units/ml. Estimation of the D50 of standardized short ragweed extracts at 250, 300, 315, 500 and 900 Amb a 1 u/ml indicated that extracts with Amb a 1 contents of 250 to 450 u/ml warranted assignment of 100,000 BAU/ml.

当标准化的杂草和草花粉提取物获得许可时， 如果它们等效于 参考 随着ID 50 EAL方法的引入，生物等效性 过敏单位目前根据皮试效力分配 在高皮肤反应性鼻炎受试者中测定。 采用ID 50 AEAL法，拟定了巨噬细胞FDA参比制剂 豚草和狗牙根进行了临床评价。 在每个参考文献中 平均D50介于11-12.9之间，表明应将其分配给 10，000 BAU/ml，而不是任意指定的100，000 Au/ml。的 百慕大草参考也在另一个地区进行了评估， 美国以确定CBER估计值是否可替代。 当 在纳什维尔选择了反应性相等的糖，无显著性差异 与CBERmuda相关的纳什维尔D50估计值的差异 发现D50估计值证实了10，000 BAU/ml的分配， 百慕大参考。 当标准化的短豚草提取物被许可并贴上标签时， 过敏单位，他们被任意指定为100，000 Au/ml，如果他们 含有200至400 Amb a 1单位/ml。D50的估计 在250、300、315、500和900 Amb a下的标准化短豚草提取物 1 u/ml表示Amb a 1含量为250 ~ 450 u/ml的提取物 100，000 BAU/ml。