Publisher's Synopsis
Excerpt from Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration: Annual Report, October 1, 1991 to September 30, 1992
Clinical evaluation of the potency of proposed cber references of pollen extracts is continuing. Clinical evaluation of Bermuda grass and giant ragweed indicated a decrease in the number of arbitrary potency units previously assigned to these products to Bioequivalent Allergy Units is required to more accurately reflect the potency of these references.
Clinical evaluation of the potency of standardized short ragweed extracts is completed. The data confirm that the number of Allergy Units arbitrarily assigned to selected Licensed products based on their Amb a I content will not require change when they are labeled as Bioequivalent Allergy Units. These data more precisely define the Amb a I content required for assignment of Bioequivalent Allergy Units.
Clinical studies of the stability of short ragweed extract is continuing. Highly dilute solutions of short ragweed Amb a I content) when stored in fda approved hsa diluent at 2-80c extract were found to be stable for 7 weeks.
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