Opened 13 years ago

Closed 12 years ago

#17 closed enhancement (fixed)

BIOEQUIVALENT ALLERGY UNITS

Reported by: Gunther Schadow Owned by: Gunther Schadow
Priority: critical Milestone: Revision 1.8
Component: Keywords:
Cc:

Description (last modified by Gunther Schadow)

Requested for FDA/CBER in order to support biologic structured product labeling:

BIOEQUIVALENT ALLERGY UNITS (typically abbreviated "BAU") - a biological potency unit assigned to several standardized allergenic extracts, following in-vitro comparison of the test extract to an FDA CBER reference standard. The FDA CBER reference standard is assigned a specific BAU unitage based on quantitative skin testing in allergic individuals.

See also #18 and #19

Attachments (1)

Turk IDEAL Ehrlich 1987.pdf (390.2 KB) - added by Gunther Schadow 13 years ago.
Biological Standardization based on Quantitative Skin Testing

Download all attachments as: .zip

Change History (9)

comment:1 Changed 13 years ago by Gunther Schadow

Description: modified (diff)

comment:2 Changed 13 years ago by Gunther Schadow

The definition is not sufficient to establish this notion as a unit.

This being an in-vitro measurement using a reference standard makes it eligible as any other arbitrary unit such as I.U.

Contrast this with #17, which is going to be very hard.

comment:3 Changed 13 years ago by Gunther Schadow

I meant "contrast this with #18" not 17.

comment:4 Changed 13 years ago by Gunther Schadow

Submitter states:

"AU and BAU are both based on FDA reference standards and, ultimately, on titration skin testing by the ID50EAL method. I have attached a reference on that method, on the BAU unitage, and on the older AU unitage."

Changed 13 years ago by Gunther Schadow

Attachment: Turk IDEAL Ehrlich 1987.pdf added

Biological Standardization based on Quantitative Skin Testing

comment:5 Changed 13 years ago by Gunther Schadow

Owner: set to Gunther Schadow
Status: newassigned

[BAU] see comment under #18. Provisionally accepted.

comment:6 Changed 12 years ago by Gunther Schadow

Milestone: Revision 1.8

comment:7 Changed 12 years ago by Gunther Schadow

While applying this, it is clear that this is still not defined as a unit.

But the Turkeltaub paper does provide a lot of detail for some metrologic formalization of what is going on.

This method needs to be further investigated to determine a quantitative model which relates that would relate 1 BAU with a standardized amount of substance of the standardized allergenic protein. The situation is not unlike the titer and is not worse than for many of the arbitrary units listed already. In a future revision a stronger formalized metrologic model will be added to this specification.

comment:8 Changed 12 years ago by Gunther Schadow

Resolution: fixed
Status: assignedclosed
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