This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical delivery systems (collectively referred to as TDS).
Adhesion performance is defined in this guidance as to whether the TDS fully adheres to the subject in the applied location for the duration of use of the TDS.
The recommendations in this guidance relate to studies to be submitted in support of a new drug application (NDA) or supplemental new drug application (sNDA) for human prescription and nonprescription drug products under Section 505 of the Federal Food, Drug, and Cosmetic Act 32 (21 U.S.C. § 355) and 21 CFR Part 314.
Because biological products are often more complex and of a higher molecular weight, it is likely that these products would not be absorbed across the skin, requiring a different approach for administration, so they are outside the scope of this guidance.
Kommentit