Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry




60Skin I/S studies are designed to compare the potential for the T and R TDS products to cause
61 irritation and/or sensitization reactions. A TDS may illicit these reactions in only some of the
62 patients using the product, but even if the frequency of this occurrence was low, the adverse
63 reactions could affect thousands of individuals among the millions who use the product. To
64 evaluate this I/S potential, applicants should compare the T and R TDS products in a relatively
65 small population (hundreds of subjects), and the study should be conducted under relatively
66 provocative conditions (repeated removal and reapplication of the TDS on the same skin site) to
67 maximize the potential for the occurrence of an irritation and/or sensitization reaction in the
68 subject population during the study.
70 Changes in environmental temperature or humidity, including the daily exposure of the TDS to
71 heat and water during routine showering, may transiently affect the rate at which components of
72 the TDS formulation are released and permeate through skin. Such changes may also affect
73 entrapped moisture in and/or under the TDS, which could alter skin hydration and impact the
74 bioavailability of formulation components, which may, in turn, change I/S reactions. Therefore,
75 when designing their I/S studies, applicants should consider any conditions of labeled use for the
76 R product that may impact the I/S potential of a TDS product (e.g., incidental exposure of the
77 TDS to water, such as while bathing or showering, particularly for a TDS with a duration of wear
78 longer than 24 hours).


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