BioScience Laboratories Skin Technology Center performs clinical evaluations for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing, December 1999.
The FDA guidance requires that the drug product and its vehicle (product without active principle) be tested, along with a high-irritancy control material, sodium lauryl sulfate (SLS; also known as sodium dodecyl sulfate, or SDS), and a low-irritancy control material, 0.9% saline, by applying small quantities to a single site on the skin of the upper back of 30 or more subjects each day for 21 days and occlusively patching each site while the applied material is wet.
If the testing is for an ANDA in which bioequivalency data are necessary, a fifth material, the so-called “Innovator patch,” is also tested, and the outcome for the test material is compared with that for the Innovator (i.e., the product already approved to market to which the test material claims equivalency).
The degree of irritation at the sites is scored for degree of erythema/vesiculation/peripheral extension each day prior to reapplication of the materials.
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