Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.

Harrison LI

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Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.

机译：FDA对鼻喷雾剂和鼻喷雾剂用于局部作用的生物等效性研究指南草案的评论：一种行业观点。

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摘要

In June 1999, the Food and Drug Administration issued draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action. The purpose of this opinion paper is to highlight the need for a balanced scientific debate before this guidance is used by underscoring the areas in the document that are in opposition to prevailing scientific understanding.

机译：1999年6月，美国食品药品管理局发布了鼻喷雾剂和鼻喷雾剂的生物等效性研究指南草案，以进行局部治疗。本意见书的目的是通过强调文档中与普遍科学理解相反的领域，强调在使用本指南之前需要进行平衡的科学辩论。

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《The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology》 |2000年第7期|共7页
作者
Harrison LI;
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原文格式 PDF
正文语种 eng
中图分类药理学;
关键词
Aerosols; Drug Approval; United States Food and Drug Administration; 气雾剂; 药物批准; 美国食品和药物管理局;

机译：Aerosols;Drug Approval;United States Food and Drug Administration;气雾剂;药物批准;美国食品和药物管理局;

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专利

1. Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view. [J] . Harrison LI The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2000,第7期

机译：FDA对鼻喷雾剂和鼻喷雾剂用于局部作用的生物等效性研究指南草案的评论：一种行业观点。
2. Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. [J] . Nave R, Herzog R, Laurent Clinical therapeutics . 2009,第12期

机译：通过口服鼻喷雾剂或氢氟烷烃鼻气雾剂与口服吸入的ciclesonide相比，ciclesonide和desisobutyryl ciclesonide的药代动力学：在健康志愿者中进行的开放标签，单剂量，三期交叉研究。
3. Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. [J] . Nave R, Herzog R, Laurent Clinical therapeutics . 2009,第12期

机译：通过鼻腔喷雾或氢氟烷烃鼻气泡给药后冠状圆角和Desisobutyll冠状藻酮的药代动力学与口腔吸入冠甲酸锡（氢萘葡萄球菌）：在健康志愿者中的开放标签，单剂量，三级交叉研究。
4. Experimental and numerical study of nasal spray characteristics and its application in a realistic human nasal cavity [C] . Xuwen TONG, Jingliang DONG, Kiao INTHAVONG, Australasian Fluid Mechanics Society;Australasian fluid mechanics conference . 2016

机译：鼻喷雾特性的实验和数值研究及其在真实人鼻腔中的应用
5. Development of a novel color based method for assessing deposition patterns of nasal sprays and nebulized aerosols. [D] . Kundoor, Vipra. 2010

机译：开发了一种基于颜色的新颖方法，用于评估鼻喷雾剂和雾化气溶胶的沉积方式。
6. Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval [O] . Bing V. Li, Feiyan Jin, Sau L. Lee, 2013

机译：局部作用的鼻喷雾剂和鼻用气雾剂产品的生物等效性：标准制定和通用批准
7. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials” [O] . Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, 2019

机译：对行业联邦调查局指导论坛的报告：“含纳米材料的药品，包括生物产品，包括纳米材料”
8. Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions [R] . 2012

机译：工业和FDa工作人员指南：FDa根据IND常见问题接受外国临床研究

Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.

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