欧美吸入制剂相关指南及文献

一、  美国FDA与美国药典USP吸入制剂相关指南

       1 ，FDA Guidance for Industry Guidance for Industry Container Closure Systems for Packaging

Human Drugs and Biologics Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics Container Closure Systems for Packing Human Drugs and Biologics

       FDA 包装密闭系统指南（化药及生物制品）

       2，USP Packaging and storage requirements

       USP包装及贮藏要求（659）

       3，Practical, regulatory and clinical considerations for development of inhalation drug products

       开发吸入给药产品的监管和临床实际考查要点

       4，Inhalation and nasal drug products-general information and product quality tests

        USP吸入制剂和鼻用制剂 ：一般信息和产品质量检查；

       5，Uniformity of dosage units of USP

       USP含量均匀度（905）

       6， Inhalation and nasal drug products: aerosols, sprays, and powders-performance quality tests

       USP（601）吸入制剂和鼻用制剂：气雾剂，喷雾剂和干粉剂-性能质量测试

       7，Guidance for industry: Integration of dose-counting mechanisms into MDI drug products

       FDA MDI行业指南集成带有剂量计数器MDI的制剂

       8， Guidance for industry: Nasal spray and inhalation solution, suspension, and spray drug products

       FDA混悬型鼻喷及干粉产品的指南（CMC部分）

       9，Guidance for industry: Metered dose inhaler and dry powder inhaler drug products

             PMDI及DPI产品指南；

二、欧盟EMA及欧洲药典EP吸入制剂相关指南

       1，EU Guideline on Plastic immediate packaging materials

        EU EMEA塑料直接接触药品包装指南

       2，Preparations for inhalation

       EP吸入制剂

       3， Preparations for nebulisation: characterisation

       EP 2.9.44喷雾制剂：特性鉴定；

       4， Pressurized pharmaceutical preparations

       EP加压药物制剂

       5，2.9.18 preparations for inhalation: aerodynamic assessment of fine particles

         EP2.9.18吸入制剂：细颗粒的空气动力学评估

       6，Guideline on the pharmaceutical quality of inhalation and nasal products

        EMEA吸入产品和鼻用制剂药学质量的指南

       7，EU guidance clinical documentation for OIPs

       经口吸入制剂的临床要求

三、PQRI 吸入制剂相关文献

Thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products  经口吸入制剂和鼻用制剂的提取和迁移的安全阈值和最好的操作方案

四、 IPAC-RS吸入制剂相关文献

Recommended Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP)

       针对经口吸入和鼻用制剂（OINDP）所用材料建议的基本要求