FDA Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Draft
标准简介
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Draft[附网盘链接]由Food And Drug Administration于当前发布，适用于United States。标准截图
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标准文档说明
标准文档类型为Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Draft[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft — Not for Implementation 1 Assessment of Adhesion for Topical and Transdermal Systems 2 Submitted in New Drug Applications 1
3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations for clinical trials designed to assess the adhesion 18 performance of transdermal and topical delivery systems (collectively referred to as TDS). 19 Adhesion performance is defined in this guidance as whether the TDS fully adheres to the 20 subject in the applied location for the duration of use of the TDS. Adhesion performance can 21 affect both safety and effectiveness of TDS products because adhesion failures can result in 22 reduced effectiveness caused by suboptimal dosing or potentially increased exposure when a new 23 TDS needs to be applied sooner than the scheduled dose. Additionally, partial or full detachment 24 of a TDS from a patient’s skin may result in unintentional exposure of the active pharmaceutical 25 ingredient to a partner, child, or other individual, potentially exposing them to the drug’s 26 toxicity. Adhesion performance may also inform the Dosage and Administration section of 27 labeling. 28 29 The recommendations in this guidance relate to studies to be submitted in support of a new drug 30 application (NDA) or supplemental new drug application (sNDA) for human prescription and 31 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 33 and of a higher molecular weight, it is likely that these products would not be absorbed across 34 the skin, requiring a different approach for administration, so they are outside the scope of this 35 guidance. 36 37 Sponsors are encouraged to contact the appropriate clinical review division in advance of 38 conducting these adhesion performance studies to discuss specific design and methodology 39 issues. 40 1
This guida nce has been prepared by the Office of New Drugs in the Center for Drug Eva luation and Research (CDER) a nd CDER’s Office of Pharmaceutical Quality, Office of Translational Sciences, a nd Office of Generic Drugs a t the Food a nd Drug Administration.
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