FDA Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Draft
标准简介
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Draft[附网盘链接]由Food&Drug Administration于之前发布，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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry 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Draft — Not for Implementation 1 Drug-Drug Interaction Assessment for Therapeutic Proteins 1
2 Guidance for Industry 3 4 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 5 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 6 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 7 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 8 for this guidance as listed on the title page. 9 10 11 12 I. INTRODUCTION 13 14 The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) 15 and applicants of biologic license applications (BLAs) determine the need for drug-drug 16 interaction (DDI) studies for a therapeutic protein (TP) by providing a systematic, risk-based 2, 3
17 approach. 18 19 For the purpose of this guidance, a TP refers to a protein, licensed as a therapeutic biological 4, 5
20 product under section 351 of the Public Health Service Act (42 U.S.C. 262). Although this 21 guidance applies to therapeutic proteins, the general concepts could be applicable to other 22 biological products, including biological products regulated by CBER such as cellular and gene 23 therapies. 24 25 This guidance supplements the final FDA guidances entitled In Vitro Drug Interaction Studies — 26 Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug 1
This guidance has been prepared by the Therapeutic Protein DDI Working Group in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research in collaboration with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2
Schrieber SJ, E Pfuma‐ Fletcher, X Wang, YC Wang, S Sagoo, R Madabushi, S Huang, and I Zineh, 2019, Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective, Clin Pharmacol Ther, 105:1332-1334. 3
Hereafter, sponsors will refer to either applicants or sponsors. 4
Section 351 of the Public Health Service Act, 42 U.S.C. § 282. 5
Please refer to the FDA web page, Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research, for more information about these products available at: https://www.fda.gov/combination-
products/classification-and-jurisdictional-information/transfer-therapeutic-biological-products-center-drug-
evaluation-and-research. 1
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