FDA Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft
标准简介
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft[附网盘链接]由Food&Drug Administration于之前发布，适用于美国。标准截图
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标准文档说明
标准文档类型为Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs 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Draft — Not for Implementation 1 Assessing Adhesion With Transdermal and Topical Delivery 2 Systems for ANDAs 1
3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 16 The recommendations in this guidance relate exclusively to studies submitted in support of an 2
17 abbreviated new drug application (ANDA). This guidance provides recommendations for the 18 design and conduct of studies evaluating the adhesive performance of a transdermal or topical 3
19 delivery system (collectively referred to as TDS ). Depending on the objectives of a TDS 20 product development program, applicants may choose to evaluate TDS adhesion in studies 21 performed to evaluate TDS adhesion only or in studies performed with a combined purpose (e.g., 22 for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) 23 endpoints). 24 25 In this guidance, the letter T (representing Test) will refer to proposed generic products that are 26 the subject of an ANDA, and the letter R (representing Reference) will refer to a reference listed 27 drug and/or reference standard product. 28 1
This guidance has been prepared by the Office of Research and Standards in the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) in cooperation with CDER’s Office of New Drugs and Office of Pharmaceutical Quality at the Food and Drug Administration. 2
The recommendations for studies characterizing TDS adhesion in a new drug application or a supplemental new drug application may be different than those submitted in support of an ANDA and may involve the assessment of different ages and strengths of the TDS product, potentially dosed to different anatomical sites. Also, the design, conduct, and assessment of TDS adhesion in studies supporting a new drug application are inherently different because TDS adhesion in that context is not typically evaluated in relation to a reference product. 3
The acronym TDS refers to both transdermal delivery systems and topical delivery systems and includes products that may described elsewhere or known as patches, topical patches, or extended release films.
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