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BIOEQUIVALENT ALLERGY UNITS #26

Closed timbrisc closed 15 years ago

timbrisc commented 15 years ago

Issue migrated from trac ticket # 17

priority: critical | resolution: fixed

2008-12-20 03:24:50: gschadow@pragmaticdata.com created the issue

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

timbrisc commented 15 years ago

2008-12-20 03:27:04: gschadow@pragmaticdata.com edited the issue description

timbrisc commented 15 years ago

2008-12-20 03:31:49: gschadow@pragmaticdata.com commented

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.

timbrisc commented 15 years ago

2008-12-20 03:32:48: gschadow@pragmaticdata.com commented

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

timbrisc commented 15 years ago

2009-02-13 06:40:24: gschadow@pragmaticdata.com commented

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."

timbrisc commented 15 years ago

2009-02-13 06:41:05: gschadow@pragmaticdata.com uploaded file Turk IDEAL Ehrlich 1987.pdf (390.2 KiB)

Biological Standardization based on Quantitative Skin Testing

timbrisc commented 15 years ago

2009-02-13 16:31:40: gschadow@pragmaticdata.com changed status from new to assigned

timbrisc commented 15 years ago

2009-02-13 16:31:40: gschadow@pragmaticdata.com changed owner from * to gschadow*

timbrisc commented 15 years ago

2009-02-13 16:31:40: gschadow@pragmaticdata.com commented

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

timbrisc commented 15 years ago

2009-07-18 17:13:11: gschadow@pragmaticdata.com

timbrisc commented 15 years ago

2009-07-18 19:59:32: gschadow@pragmaticdata.com commented

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.

timbrisc commented 15 years ago

2009-07-18 19:59:46: gschadow@pragmaticdata.com changed status from assigned to closed

timbrisc commented 15 years ago

2009-07-18 19:59:46: gschadow@pragmaticdata.com set resolution to fixed