FDA Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft

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Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft[附网盘链接]是Food&Drug Administration于当前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Assessing the Irritation and Sensitization Potential of Generic 2 Transdermal and Topical Delivery Systems for ANDAs 1

3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic.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 listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations for the design and conduct of studies to evaluate the in 18 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 2

19 system (collectively referred to as TDS ). The recommendations in this guidance relate 3

20 exclusively to studies submitted in support of an abbreviated new drug application (ANDA). 21 22 In this guidance, the letter T (representing Test) will refer to proposed generic products that are 23 the subject of an ANDA, and the letter R (representing Reference) will refer to the reference 24 listed drug and/or reference standard product. 25 26 The recommendations relating to the design and conduct of I/S studies described in this guidance 4

27 replace the recommendations related to I/S studies provided in product-specific guidances 28 published before this guidance. Nonetheless, FDA recommends that applicants consult this 29 guidance in conjunction with any relevant product-specific guidances that contain product-

30 specific recommendations (1) for their I/S study (such as the strength of the TDS, the duration of 31 wear for the specific TDS, and the frequency of scoring observations) or (2) for other in vivo 32 studies (such as adhesion or pharmacokinetics) that may be necessary to establish the 1

This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) in cooperation with CDER’s Office of Translational Sciences at the Food and Drug Administration. 2

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. 3

The recommendations for studies characterizing the TDS irritation or sensitization potential in a new drug application or a supplemental new drug application may be different than those submitted in support of an ANDA. The design, conduct, and assessment of TDS irritation and sensitization in studies supporting a new drug application are inherently different because TDS irritation/sensitization in that context is not typically evaluated in relation to a reference product. 4

Generic drug product-specific guidances are available at the Product-Specific Guidances for Generic Drug Development web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm.

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