系列3：评估原则Principles for Evaluating
本部分涉及为仿制药申请人提供了仿制药研究的一般原则指南（如橙皮书问答、如何识别参比制剂等），以及一些特殊产品的评估原则（如经皮或局部给药系统、口服固体阿片类药物、合成肽和药械组合产品）。
3.1_Orange Book Questions and Answers
3.1_橙皮书问答指南
发布日期：05/27/2020
目前状态：草案
This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). This guidance provides answers to commonly asked questions that we have received from these interested parties regarding the Orange Book.
针对潜在的药品申请人，药品申请人和批准的申请持有人，本指南旨在为其提供帮助，包括利用批准的具有治疗等效性的药品评估出版物(橙皮书)。针对FDA收到的有关橙皮书的常见问题，本指南提供了相关解答。
3.2_Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
3.2_使用透皮给药系统和局部贴剂评估粘附性，以支持ANDA
发布日期：10/10/2018
目前状态：草案
The recommendations in this guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA). This guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).
本指南中的建议仅与支持ANDA申请的研究有关。为评估经皮或局部给药系统(统称为TDS)的粘合性能的研究设计和执行，本指南提供了建议。根据TDS产品开发计划的目标，申请人可以选择在仅评估TDS粘附力的研究中、或在具有综合目的的研究中，评估TDS粘附力，例如，用于同时评估粘附力、生物等效性(BE)和药代动力学(PK)终点。
3.3_Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
3.3_评估ANDA的透皮和局部给药系统的刺激性和致敏性
发布日期：10/10/2018
目前状态：草案
This draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).
该指南草案为设计和进行研究提供了建议，以评估提议的经皮或局部给药系统(统称为TDS)的体内皮肤刺激和致敏(I/S)潜力。本指南草案中的建议，仅与为支持ANDA申请而提交的研究有关。
3.4_General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
3.4_评估口服固体阿片类仿制药防止滥用措施的一般原则
发布日期：11/21/2017
目前状态：定稿
This guidance is intended to assist a person who plans to develop and submit an abbreviated new drug application (ANDA) (hereinafter potential ANDA applicant) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse-deterrent properties described in its labeling.
本指南旨在帮助计划开发并提交ANDA申请的人员(以下称潜在的ANDA申请人)，以寻求批准口服固体阿片类仿制药，防止滥用措施在其标签中描述。
The guidance recommends studies, including comparative in vitro and pharmacokinetic (PK) studies, that the potential ANDA applicant should conduct and submit to FDA in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.
该指南建议研究，包括比较性体外和药代动力学(PK)研究，潜在的ANDA申请人应进行ANDA申请并提交给FDA，以证明仿制固体口服阿片类药品的防止滥用措施不低于其参比制剂(RLD)所有潜在途径。
3.5_ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin
3.5_某些高度纯化的合成肽的ANDA，参比rDNA来源药物
发布日期：10/03/2017
目前状态：草案
This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under section 505(b) of the FD&C Act.
本指南旨在帮助潜在申请人，针对合成肽药物申请(参考已批准的rDNA来源的肽药)，决定是否应根据联邦FD＆C法案第505(j) 条作为ANDA提交，而不是根据第505(b) 条以NDA提交 。
Specifically, this guidance covers the following five peptide drug products: glucagon, liraglutide, nesiritide, teriparatide, and teduglutide.
具体而言，本指南涵盖以下五种肽类药品：胰高血糖素，利拉鲁肽，奈西立肽，特立帕肽和替度鲁肽。
3.6_Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
3.6_ANDA中提交的药械组合产品：比较分析和比较使用人为因素研究
发布日期：01/17/2017
目前状态：草案
This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part. The recommendations included in this guidance generally focus on the analysis of the proposed user interface for the generic drug-device combination product (generic combination product) when compared to the user interface for the reference listed drug (RLD).
本指南旨在帮助计划开发和提交ANDA的潜在申请人，以寻求对既包含药品成分又包含给药装置成分的组合产品的批准。与参比制剂(RLD)的用户界面相比，本指南中包含的建议，集中于对仿制药械组合产品的拟议用户界面的分析。
For the purposes of this guidance, the term user interface refers to all components of the combination product with which a user interacts. This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging.
就本指南而言，术语“用户界面”是指与用户进行交互的组合产品的所有组件。这包括组合产品的传送设备组成部分、任何相关的控件和显示，以及产品标签和包装。
3.7_Referencing Approved Drug Products in ANDA Submissions
3.7_在ANDA提交中，参比批准的药品
发布日期：01/13/2017
目前状态：草案
This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission.
如何识别参比制剂(RLD)，参比标准以及ANDA提交基准，本指南旨在向潜在申请人提供有关信息。
