FDA发布仿制药片剂与胶囊尺寸、形状及其他物理属性最终指南（二级修订版）
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
FDA发布关于仿制药片剂与胶囊尺寸、形状及其他物理属性的最终指南，标注为二级修订版，案卷编号FDA-2013-N-1434。该指南由CDER发布，正文提及片剂与胶囊在储存、携带、给药便利和剂量准确性方面的优势。文件说明可依据21 CFR 10.115(g)(5)随时提交意见。
材料为FDA发布的仿制药片剂与胶囊物理属性最终指南，标注二级修订并给出案卷编号，便于按编号定位文件。
GUIDANCE DOCUMENT
Final Level 2 Revised Guidance
- Docket Number:
- FDA-2013-N-1434
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.
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-2013-N-1434.
来源：FDA Pharmaceutical Quality Documents · fda.gov