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...
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。
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。
”2The draft addresses current thinking in relation to these types of pharmaceuticals. The draft seeks to replace the 2006 edition of the guidance3as well as supplementary questions and answers posted on the EMA website.4A companion document, “Guideline On The Requirements For Clinical ...
EMA https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/qualification-novel-methodologies-medicine-development-0 (2021). European Medicines Agency. Qualification of novel methodologies for drug development: Guidance to applicants. EMA https://www.ema....
Section 6.4: "Tallow derivatives" of the EMA's guidance EMA/410/01 rev.3 and the European Pharmacopoeia monograph 5.2.8 on Minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products have given specific consideration to tallow derivatives...
EMA: European Medicines Agency PMDA: Pharmaceuticals and Medical Devices Agency ISPE: International Society for Pharmaceutical Engineering ADC: Antibody drug conjugate MAPP: Manual of Policies and Procedures CAR-T: Chimeric antigen receptor (CAR) T cell therapy AI: Acceptable intake TTC: Thre...
product manager Ensure technical collaboration and knowledge transfer during sales offers and projects. 7. Support the field force in any specific issues related to install base business, Inform the field about developments, strategies and market programs, Comply to national and local regulations and sa...
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。