III. EVALUATION OF ADHESION
69 A. Study Design and Conduct
71 In general, the Agency recommends that applicants design their adhesion studies to support a
72 comparative evaluation of the adhesion characteristics of the T and R TDS.
74 FDA recommends that applicants use a single-dose, randomized, two-treatment, two-period
75 crossover study design where all subjects are dosed with the same strength of the T and R TDS.
76 However, FDA may also consider the acceptability of a study using a single-period, two77
treatment-per-subject design, with the site of application randomized, if applicants appropriately
78 justify their parallel dosing study design. The population for the TDS adhesion study should
79 typically be the same as the population enrolled, or recommended for enrollment, in the PK BE
80 study for the product and should typically include healthy males and non-pregnant, non-lactating
81 females unless product-specific considerations indicate otherwise.
83 Applicants should randomize subjects to receive either the T or R TDS product in a given study
84 period. When possible, the TDS administered in the second study period should be applied to the
85 same anatomical site as in the first study period, but on the contralateral side of the body.
87 Because alterations in the product design, the active or inactive ingredients, the backing
88 membrane, or the manufacturing process can affect the adhesion properties of a TDS, the study
should utilize the to-be-marketed TDS product.
7 89 Post-approval changes to the TDS may
90 necessitate confirmation that product quality attributes related to adhesion remain consistent with
91 the product quality attributes characterized for the TDS product that demonstrated acceptable
94 Unless otherwise justified, when conducting an adhesion study, applicants should utilize the
95 specific size/strength of the TDS that is recommended in the applicable product-specific
96 guidance. A larger TDS may be more sensitive to detachment than a smaller one because the
97 larger TDS may be subjected to greater conformational or torsional strains arising from
98 potentially increased anatomical curvatures or from a greater magnitude of flexion across
99 relatively greater anatomical distances across which the larger TDS may be adhered. It may also
100 be possible for applicants to assess an adhesion score more precisely with a larger TDS than with
101 a smaller one.
Continue at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm504157.pdf
The text above is owned by the site above referred.
Here is only a small part of the article, for more please follow the link