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...
Recently, a guideline has been published by the European Medicines Agency (EMA) on setting safe limits, permitted daily exposures (PDE) , for medicines manufactured in multi-product facilities. The ADE provides a safe exposure limit for inadvertent exposure of a drug due to cross-contamination ...
April 2015 Adoption by CHMP 21 May 2015 Date for coming into effect 1 December 2015 *This guideline was previously published as part of a “compilation of individual product-specific guidance on demonstration of bioequivalence Rev.3 EMA/CHMP/736403/2014” Keywords Bioequivalence, generics, tadalafil...
由欧洲药品管理局(EMA)发布的关于Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance(依维莫司片0.25mg、0.5mg、0.75mg和1mg;2.5m
EMA. Guideline on pharmaceutical quality of inhalation and nasal products, EMEA/CHMP/QWP/49313/2005 Corr. 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/qual...
9December2013 EMA/488220/2012 Guidelineongoodpharmacovigilancepractices(GVP) Product-orPopulation-SpecificConsiderationsI:Vaccinesforprophylaxis againstinfectiousdiseases DraftfinalisedbytheAgencyincollaborationwithMemberStates21February2013 DraftagreedbyERMSFG8March2013 DraftadoptedbyExecutiveDirector9April2013 Startofpu...
After repeated testing of different hiPSC lines with both OCT3/4 dilutions and obtaining cell line-specific results, we opted for the inclusion of two different concentrations in QC analyses to assess OCT3/4. Staining for SOX2 proved to be difficult (Figure 7C), with none of the antibody ...
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...
由欧洲药品管理局(EMA)发布的关于Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance(泊沙康唑口服混悬液40 mg/ml产品特异性生物等效性指南),来源于药智数据政策法规数据库。
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。