FDA 发布液体和/或软食作为给药载体的选择及产品质量体外评价指南草案

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

AI 导读

FDA 发布一份指南草案，就口服药品以液体和/或软食作为给药载体提供选择考虑和产品质量体外评价建议。文件编号 FDA-2018-D-2544，适用于 IND、NDA、BLA 及相关补充申请，标注为草案、不适用于实施且为非约束性建议。可通过线上或书面方式随时提交意见。

推荐理由

该草案就口服药品使用液体或软食作为给药载体给出选择考虑与产品质量体外评价建议，并说明其适用范围。

正文 · 原文

GUIDANCE DOCUMENT

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2018-D-2544

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-2544.