由欧洲药品管理局(EMA)发布的关于Tadalafil product-specific bioequivalence guidance(他达拉非-生物等效性),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。
21 May 2015 EMA/CHMP/315234/2014 Committee for Medicinal Products for Human Use (CHMP) Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance* Draft agreed by Pharmacokinetics Working Party (PKWP) October 2013 Adoption by CHMP for release for consultation 24...
The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are...
EMA: European Medicines Agency EU: European Union FCS: Flexible care setting FDA: Food and Drug Administration HPI: Highlights of Prescribing Information IBD: Inflammatory bowel disease IFNβ: Interferon beta IRR: Infusion-related reaction mAb: ...
Guidance for industry: food-effect bioavailability and fed bioequivalence studies. Rockville, U.S. Food and Drug Administration; 2002. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/food-effect-bioavailability-and-fed-bioequivalence-studies. Accessed: 14 September, 2023. Hai ...
The tiny-TIMsg system, as part of the SurroGUT™ platform, precisely mimics the upper GI tract and all physiologically relevant processes; including the pressure, shear forces and phase specific gastric emptying. The tiny-TIMsg consists of an advanced gastric compartment (TIMagc) and small inte...
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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。
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