Draft tadalafil product-specific bioequivalence guidance(他达拉非产品特定生物等效性指南草案) 【发布部门】 欧洲药品管理局(EMA) 【效力级别】 指导原则 【发布日期】 2013-11-15 【时 效 性】 现行有效 附件1 : draft guideline VIP试用医疗器械查询APP下载客服中心常见问题数据可视化数据分析挖掘系统网站地图...
EMA. Quality of medicines questions and answers: Part 2 Specific type of products at:https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-medicines-qa-introduction/quality-medicines-questions-answers-part-2 EMA. Guideline On The Requirements For...
LC-MS/MS methods are nowadays commonly used for nitrosamines analysis in all types of materials, since it allows analyte-specific detection based on both retention time and structurally specific fragmentation information in conjunction with high sensitivity. After the establishment of the ni... Produ...
This has changed with a newdraft guidance document from the European Medicines Agency, Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container, issued in April 2016 for public comment. The key points are reviewed in this article.Sandle...
由欧洲药品管理局(EMA)发布的关于Capecitabine film-coated tablets 150, 500 mg product-specific bioequivalence guidance(卡培他滨薄膜包衣片150500mg产品特异性生物等效性指导),来源于药智数据政策法规数据库。
Guideline on good pharmacovigilance practices (GVP) module VI—Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2), EMA/873138/2011 Rev 2 (2017). MedDRA Maintenance and Support Services Organization. Patient-friendly term list. MedDRA MSSO....
(1:10). The endpoint was determined to be 0.03 EU/mL, confirming that the product at this dilution does not interfere with clot formation. The sensitivity of the test calculated for this specific product was calculated according to the formula: sensitivity × chosen dilution (0.03 EU/mL...
One of the challenges in Good Manufacturing Practice (GMP)-compliant human induced pluripotent stem cell (hiPSC) production is the validation of quality control (QC) tests specific for hiPSCs, which are required for GMP batch release. This study presents a comprehensive description of the validation...
The purpose of the ATMP cluster is to provide a forum for US FDA and EMA to share thinking on regulatory approaches, both in general and on specific issues, to share information on draft documents, and to discuss participation in workshops, advisory committees, and working parties. The ATMP ...
In September 2022, Together for Sustainability (TfS) launched the Product Carbon Footprint (PCF) Guideline. It enables companies to calculate the PCFs of their chemical materials more precisely in a way that is harmonized across the industry, while remaining fully compliant with less specific inter...