SENSITIZATION POTENTIAL (FDA-MANDATED):
BioScience Laboratories performs sensitization testing (potential induction of Type IV allergy) by the Modified Draize Test in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, December 1999. The Modified Draize Test can be performed concomitant with the RIPT.
The method requires that the product and its vehicle (product without active principle) be tested. During the Induction Phase of testing, test materials are applied to skin sites on the upper backs of 200 subjects and patched three times per week for three weeks, the same sites of application each time, for a total of nine applications. Patches remain in place 48 hours at a time on weekdays and 72 hours on weekends. Evaluation and scoring of skin reactions are performed and recorded at the time of each patch removal.
The Induction Phase is followed by a Rest Phase of two weeks duration, during which no product applications are performed.
Then, during the Challenge Phase, materials are applied to new skin sites on the back and patched for a 48-hour period of exposure, at the end of which patches are removed. The challenge sites are evaluated 30 minutes and 24, 48, and 72 hours after patch removal for evidence of allergic reaction.
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