经口吸入药物产品 PSG:使用建模和模拟与替代 BE 方法的考虑因素 3.OPQR Testing & Research to Support Guidance Development of Inhalation Products OPQR 测试与研究支持吸入产品的指导开发 4.Q&A Panel:Research to Support Guidance De...
5月20日,FDA正式发布了50份产品特定指南(Product Specific Guidance,PSGs),其中包括36份新的指南和14份修订版指南。这一举措标志着此前因仿制药办公室(Office of Generic Drugs,OGD)人员调整导致的发布延迟问题得以缓解,令广大仿制药企暂且松了口气。 P...
5月20日,FDA正式发布了50份产品特定指南(Product Specific Guidance,PSGs),其中包括36份新的指南和14份修订版指南。这一举措标志着此前因仿制药办公室(Office of Generic Drugs,OGD)人员调整导致的发布延迟问题得以缓解,令广大仿制药企暂且松了口气。 PSGs是FDA为仿制药研发和审批提供具体指导的重要文件。...
Guidance for Industry Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — Chemistry, Manufacturing, and Controls Documentation ` U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2002 CMC ...
Food and Drug Administration (FDA) guidance on the Phase 3 clinical trial for AD04.View Get Alert BOLT Bolt Biotherapeutics, Inc BDC-3042 For the treatment of cancer — 05/08/2025 9:07 AM Provided Update Bolt Biotherapeutics announced it will host a key opinion leader (KOL) conference call...
nasal solutions and inhalation products. The USP Microbiological Attributes Chapter <1111> provides little specific guidance other than "The significance of microorganisms in non-sterile pharmaceutical products should be evaluated in terms of the use of...
FDA guidance on inhalation drug containers. (Washington Insider).(Brief Article)Dickinson, James GMedical Marketing & Media
recommended in vitro studies for establishing bioequivalence (BE) found in FDA product-specific guidances (PSGs) for nasal sprays, but not for MDI products, and whether the LD based droplet size distribution of aerosols exiting MT mod...
At least 50 units for each batch of test and reference products, including placebos (if applicable), must be retained for BE studies for Budesonide Inhalation Suspension drug product, in line with the FDA draft Guidance for Industry “Bioavailability and Bioequivalence Studies for Nasal Aerosols...
美国FDA 指导原则 局部用鼻雾剂和喷雾剂的生物利用度和生物等效性研究 英文原版.pdf,Guidance for Industry Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action DRAFT GUIDANCE This guidance document is being distribut