ASSIGNMENT OF BIOEQUIVALENT ALLERGY UNITS TO POLLEN EXTRACT

当标准化的杂草和草花粉提取物获得许可时，他们 被任意分配100，00AU/ml，如果它们等于 参考资料。随着ID50EAL方法的引入，生物等效性 目前，过敏单位是根据皮肤测试效力分配的 在高皮肤反应性鼻炎受试者中检测。 采用ID50AEAL方法，推荐GIGNAL的FDA参比制剂 对豚草和百慕大草进行了临床评价。在每个参考文献中 平均D50在11-12.9之间，表明他们应该被分配 10,000 BAU/ml，而不是随意分配的100,000 AU/ml。这个 百慕大草的参考也在另一个地区进行了评估 美国将确定CBER的估计是否可替代。什么时候 在纳什维尔选择了反应性相同的受试者，没有显著意义 与纳什维尔D50关于CBERuda的估计不同 发现D50估计确认将10,000 BAU/ml分配给 百慕大参考。 当标准化的短豚草提取物获得许可并在 过敏单位，他们被随机分配10万AU/ml，如果他们 含有200至400安培a 1单位/毫升。 250、300、315、500和900安培a的标准短豚草提取物 1u/ml表明含AmbA1的提取物含量为250~450u/ml。 保证分配100,000 BAU/ml。

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.