FDA发布透皮及相关给药系统残留药物行业指南最终版
Residual Drug in Transdermal and Related Drug Delivery Systems
FDA发布《透皮及相关给药系统残留药物》行业指南最终版，面向透皮给药系统、黏膜给药系统及局部贴剂产品的开发者和生产商。指南建议在产品设计开发以及生产和产品生命周期管理阶段采用适当的科学方法，尽量减少标示使用期末的残留药物量。文件由CDER发布，2011年8月定稿，Docket编号为FDA-2010-D-0246，各方可按21 CFR 10.115(g)(5)随时在线或书面提交意见。
GUIDANCE DOCUMENT
Residual Drug in Transdermal and Related Drug Delivery Systems Guidance for Industry August 2011
Final
- Docket Number:
- FDA-2010-D-0246
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and development—as well as during manufacturing and product lifecycle management—to ensure that the amount of residual drug substance at the end of the labeled use period is minimized.
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-2010-D-0246.
来源：FDA Pharmaceutical Quality Documents · fda.gov