The determination of equivalent doses of standardized allergen vaccines

摘要: Abstract Background: Standardized allergen vaccines are tested for potency by manufacturers using assays proposed in their license applications and approved the Center Biologics Evaluation Research, which reviews verifies test results before lot release. The current lot-release limits mite grass pollen impose statistical equivalence to national reference extract; thus primarily based on assay variability. Objective: We sought establish a clinical basis relative of evaluate alternative specifications. Methods: performed literature selection review, linear logistic regression analyses selected studies, analysis lots submitted Food Drug Administration approval since 1995. Results: Therapeutic is achieved over 10-fold range concentration. Safety more difficult assign, but injection data, 4-fold increase concentration associated with 5% 10% adverse reaction rates. SD log allergenic products was determined be 0.090 grasses 0.061 mites, compared 0.079 competition ELISA. Conclusions: Current well within literature-based estimates therapeutic, diagnostic, safety ranges use vaccines. In addition, aggregate consistency comparable precision that used assess products. These support expanded release verification potency, provided material remain at present level consistency. (J Allergy Clin Immunol 2000;105:468-74.)