由欧洲药品管理局(EMA)发布的关于Carglumic acid product-specific bioequivalence guidance(卡谷氨酸-生物等效性),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...
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。
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...
Bioequivalence study designs for generic solid oral anticancer drug products: Scientific and regulatory considerations To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA ... P Kaur,CS Chaurasia,BM Davit...
8 PSGs for complex products (5 new and 3 revised PSGs), several of which include in vitro bioequivalence (BE) options for assisting generic drug development. Notable new guidances for complex products include: Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifen...
applicable),penetrationenhancercontent,andotherteststhatmaybeproductspecific.Productperformancetestingassesses drugreleaseandotherattributesthataffectdrugreleasefromthefinisheddosageform. Thischapterprovideslistsofconsolidatedcommonproductqualitytestrequirementsinaconciseandcoherentfashion.This ...
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...
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