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BAU

, Bioequivalent Allergy Unit. A potency unit used to characterize biological activity of select standardized allergen extracts.

BAU

was defined using skin prick test titrations in a sensitized patient population. Reference standards were then established by the FDA and utilized by extract manufacturers to maintain the defined relative potency for the specific, standardized extract. This… read more

References

Home > References References General References Used Throughout Stability References Painful Injection From 50% Glycerin FDA Standardization Major Allergen And Standardization Regional Relevance Of Allergens Cross-Reactivity Management Of Anaphylaxis Coring & Syringe Technique Skin Testing USP 797 References – Beyond Use Date, Pharmacy Compounding Rules Allergen Information General References Used Throughout Cox, L, et al.… read more

Standardized

An extract that has approved methods for measuring and assigning potency using an FDA standard reference. These extracts are labeled in Bioequivalent Allergy Units (

BAU

), Allergy Units (AU) and Amb a 1 (AgE) units. read more

AU

A potency unit that expresses the relative biologic activity of an allergenic extract compared to an FDA-issued standard. House Dust Mite extracts are the only extracts that are standardized using AU. read more

Amb a 1

A major allergen contained in short ragweed pollen. Short ragweed extracts are labeled with AgE concentrations (now called Amb a 1) The concentration of AgE (i.e., Amb a 1) is measured for each manufactured lot of extract, using a standardized assay. Clinical studies have been conducted, which established a therapeutic dose range for Ragweed allergy… read more

Dilution Tables

Dilution Tables Here are some common dilution strategies used when making treatment vials. 5 – Fold Dilution – 5 mL Vials – 1:20 w/v Glycerinated Extract: 1:2 Dilution – 10mL and 5mL Vials: Used for example, when you want to convert a 1:10 w/v into a 1:20 w/v or if you want to convert 10,000… read more

Dose Calculations for the Maintenance Vial

Dose Calculations for the Maintenance Vial Theformulabelowoffersasimpliﬁedmethodforcalculatingthevolumeofan extract to add based on the target dose selected. Importantly, thiscalculationcanbeusedforanypotencyunit(AU,

BAU

, PNU, w/v, or µg). V = 10T/E V: Volume to be drawn up from the manufacturer’s bulk concentrate and added to the patient’s vial T: Target maintenance dose in 0.5cc injection (e.g., 2000

BAU

, 1000PNU, 7.5µg Der… read more

Analytical Method – ID50EAL (“IDEAL 50”)

Analytical Method – ID50EAL (“IDEAL 50”) Standardized potency values were established by a skin test titration study (ID50EAL) using a limited number of patients. “ID50EAL” is an acronym for “Intradermal Dilution for 50 mm sum of Erythema determines the bioequivalent ALlergy units.” This study measured the size of the erythema in allergic patients receiving a… read more

Dosing

Dosing One of the primary objectives when mixing allergenic extracts is to prepare a patient’s treatment set in a way that ensures an optimal therapeutic dose of each allergen in the patient’s allergen extract vial. Therefore, the limiting step when mixing is deciding what volume of each allergen to add to a patient’s maintenance vial.… read more

Effect of Formulation on Stability

Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk… read more

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BAU