FDA重新发布鼻用气雾剂和鼻喷雾剂局部作用生物利用度和生物等效性研究指南草案并征求意见
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
FDA宣布重新发布《用于局部作用的鼻用气雾剂和鼻喷雾剂的生物利用度和生物等效性研究》指南草案并再次征求意见。该文件为1级指南草案，属非约束性建议、不供实施，面向拟通过NDA或ANDA证明BA或BE的申报人，覆盖鼻用气雾剂（定量吸入器）和鼻喷雾剂（定量喷雾泵）。文件最初于1999年6月24日发布征求意见，因已作多项实质性修改而重新发布，书面评论需注明案卷号FDA-1999-D-0050。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-1999-D-0050
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.” This draft document provides recommendations to applicants planning product quality studies to document bioavailability (BA) or bioequivalence (BE) in support of new drug applications (NDAs), or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers) and nasal sprays (metered-dose spray pumps). The draft guidance was originally issued for comment on June 24, 1999. Since many substantive changes have been made to the guidance, it is being reissued for comment as a level 1 draft guidance.
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-1999-D-0050.
来源：FDA Pharmaceutical Quality Documents · fda.gov