对其潜在风险进行分类,分为高、中、低三个级别,Tier 1 采用等效性检验法,评价标准为候选药和参照药均值差值的90%置信区间处于等效界值范围内即为等效,等效界值取值为±1.5 倍参照药标准差(±1.5 SD);Tier 2 采用质量范围法,评价标准为90%以上候选药批次落在参照药质量范围内(Mean±3 SD)即为相似;Tier...
然后,根据质量属性对安全性、有效性、免疫原性的潜在影响进行Tier风险分级及统计方法确定:①与作用机理相关的临床风险最高或与作用机理直接相关的质量属性分级为Tier 1,如可溶性TNFα结合活性,凋亡抑制活性;采用等效性检验法进行可比性评价,评价标准为:均值差值的90%置信区间处于等效界值(equivalence margin,EAC)范围内即...
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Three-tier drug benefit plan cuts payer costsGuideline-utilisationPharmacoEconomics & Outcomes News -doi:10.1007/BF03269625NoneSpringer International PublishingPharmacoeconomics & Outcomes News
W. I. JOTTIERLab. Anal. Chem. Med. Fysicochem., Kathol. Univ. Leuven, B-3000 Leuven, Belg.H. L. DE WINTERLab. Anal. Chem. Med. Fysicochem., Kathol. Univ. Leuven, B-3000 Leuven, Belg.O. M. PEETERSLab. Anal. Chem. Med. Fysicochem., Kathol. Univ. Leuven, B-3000 Leuven,...
The training was performed on a node of the pre-exascale Tier-0 EuroHPC supercomputer LEONARDO (supercomputer center CINECA, Italy), in four epochs using the TS with a minibatch size of 256 and using the Adam optimizer [67] (learning rate is 10−3,β1 = 0.9 and β2 = 0.999) with...
All isolates have been maintained at the Institute for Parasitology and Tropical Veterinary Medicine of the Freie Universität in Berlin for several years. All animal experiments were in agreement with the European directive 2010/63/EU and the German law (Tierschutzgesetz) and were approved by the...
Während ein Therapeutisches Drug Monitoring (TDM) für andere Immunsuppressiva gut etabliert ist, wird die Verwendung dieses Instruments zur Individualisierung und Optimierung der Mycophenolsäuretherapie seit Jahren kontrovers diskutiert. Diese Zusammenfassung konzentriert sich auf die zugrunde liegen...
In a move to break free from the tyranny of top-tier science journals like Nature and Science, Nobel laureate Randy Schekman announced that his lab will be boycotting these publications. This also brings to mind the Streptokinase Vs tpA study debate and the BMJ reporting that with the ...