Quality & Compliance
Safety & Vigilance
03 july 2023
In October 2018, FDA released the draft guidance for the industry Assessing Adhesion With Transdermal and Topical Delivery Systems and Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for abbreviated new drug applications (ANDAs). Recently, in April 2023, FDA published two revised draft guidance related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted in support of ANDAs.
The revised draft guidance for industry, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, has provided updated recommendations for designing and conducting studies evaluating the adhesive performance of a TDS submitted to support an ANDA. FDA recommends a single-dose, randomised, two-treatment, two-period crossover study design where all subjects are dosed with the same strength of the Test and RLD TDS. However, a single-period, two-treatment-per-subject design (e.g., a matched pairs study), with the application site randomised, would also be acceptable with proper justification of study design. The study could be conducted in healthy males and non-pregnant, non-lactating females. Use of specific size/strength of the TDS in the applicable product-specific guidance to be used, but a larger TDS may be used instead as it is more sensitive to detachment than a smaller one and larger TDS may be subjected to greater conformational or torsional strains arising from potentially increased anatomical curvatures or from a greater magnitude of flexion across relatively greater anatomical distances across which the larger TDS may have adhered.
The revised draft guidance for industry, Assessing the Irritation and Sensitisation Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitisation (I/S) potential of a proposed TDS. Skin I/S studies are designed to compare the similarity between the test and RLD TDS products for the potential to cause irritation and/or sensitisation reactions. A TDS may elicit these reactions in only some of the patients using the product, but even if the frequency of this occurrence were low, the adverse reactions could affect thousands of individuals. To evaluate this I/S potential, applicants should compare the test and RLD TDS products in at least 200 evaluable subjects. In addition, when designing their I/S studies, applicants should consider any conditions of labelled use for the RLD that may impact the I/S potential of a TDS product (e.g., incidental exposure of the TDS to water, such as while bathing or showering, particularly for a TDS with a duration of wear that is up to or greater than 24 hours).
Revised USFDA guidance provides in-depth insight into the development of Transdermal and Topical Delivery Systems for ANDA. This revised guidance provides study design, population, endpoint, and statistical analysis information. It also provides situations when in vivo studies can be waived, and alternate scales can be used.
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