No QT interval prolongation effect of sepiapterin: a concentration-QTc analysis of pooled data from phase 1 and phase 3 studies in healthy volunteers and patients with phenylketonuria [0.03%]
孢吡品因无延长QT间期作用：健康人群和苯酮尿症患者一期及三期临床研究的汇总数据分析结果显示
Lan Gao,Yongjun Hu,Neil Smith et al.
Lan Gao et al.
Sepiapterin is an exogenously synthesized new chemical entity that is structurally equivalent to endogenous sepiapterin, a biological precursor of tetrahydrobiopterin (BH4), which is a cofactor for phenylalanine hydroxylase. Sepiapterin is ...
Do P-glycoprotein-mediated drug-drug interactions at the blood-brain barrier impact morphine brain distribution? [0.03%]
P-糖蛋白介导的血脑屏障药物相互作用影响吗啡向脑内分布吗？
Berfin Gülave,Ariel Lesmana,Elizabeth Cm de Lange et al.
Berfin Gülave et al.
P-glycoprotein (P-gp) is a key efflux transporter and may be involved in drug-drug interactions (DDIs) at the blood-brain barrier (BBB), which could lead to changes in central nervous system (CNS) drug exposure. Morphine is a P-gp substrate...
Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan [0.03%]
基于模型的药物研发（MIDD）在日本申报注册中的剂量选择应用
JPMA MIDD Task force;Tomohiro Sasaki,Takayuki Katsube,Seiichi Hayato et al.
JPMA MIDD Task force;Tomohiro Sasaki et al.
Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Phar...
Translational pharmacokinetic and pharmacodynamic modelling of the anti-ADAMTS-5 NANOBODY® (M6495) using the neo-epitope ARGS as a biomarker [0.03%]
基于ARGS新表位生物标志物的抗ADAMTS-5 NANOBODY®(M6495)的转化药代动力学和药效学模型研究
Joao N S Pereira,Ingrid Ottevaere,Benedikte Serruys et al.
Joao N S Pereira et al.
M6495 is a first-in-class NANOBODY® molecule and an inhibitor of ADAMTS-5, with the potential to be a disease modifying osteoarthritis drug. In order to investigate the PK/PD (pharmacokinetic and pharmacodynamic) properties of M6495, a sin...
Novel endpoints based on tumor size ratio to support early clinical decision-making in oncology drug-development [0.03%]
基于肿瘤大小比例的新型终点支持早期临床决策以促进抗癌药物研发
Shubhadeep Chakraborty,Kshitij Aggarwal,Marzana Chowdhury et al.
Shubhadeep Chakraborty et al.
In oncology drug development, overall response rate (ORR) is commonly used as an early endpoint to assess the clinical benefits of new interventions; however, ORR benefit may not always translate into a long-term clinical benefit such as ov...
QSP modeling of a transiently inactivating antibody-drug conjugate highlights benefit of short antibody half life [0.03%]
基于QSP的模拟证明瞬时失活抗体药物偶联物相比短半衰期抗体具有优势
Eshita Khera,Lekshmi Dharmarajan,Dominik Hainzl et al.
Eshita Khera et al.
Antibody drug conjugates (ADC) are a promising class of oncology therapeutics consisting of an antibody conjugated to a payload via a linker. DYP688 is a novel ADC comprising of a signaling protein inhibitor payload (FR900359) that undergoe...
A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients [0.03%]
一种用于肾功能不全患者精准给药的PopPBPK-RL方法学研究：以苯那普利为例
Guillermo Vigueras,Lucía Muñoz-Gil,Valerie Reinisch et al.
Guillermo Vigueras et al.
Current treatment recommendations mainly rely on rule-based protocols defined from evidence-based clinical guidelines, which are difficult to adapt for high-risk patients such as those with renal impairment. Consequently, unsuccessful thera...
Model-informed approach to estimate treatment effect in placebo-controlled clinical trials using an artificial intelligence-based propensity weighting methodology to account for non-specific responses to treatment [0.03%]
基于人工智能倾向性权重方法的安慰剂对照临床试验非特异性治疗效应估计模型化方法研究
Roberto Gomeni,F Bressolle-Gomeni
Roberto Gomeni
In randomized, placebo controlled clinical trials (RCT) in major depressive disorders (MDD), treatment response (TR) is estimated by the change from baseline at study-end (EOS) of the scores of clinical scales used for assessing disease sev...
Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials [0.03%]
总计分模型在临床试验中检测药物效应的功效和Ⅰ类错误比较研究
Elham Haem,Mats O Karlsson,Sebastian Ueckert
Elham Haem
Composite scale data consists of numerous categorical questions/items that are often summed as a total score and are commonly utilized as primary endpoints in clinical trials. These endpoints are conceptually discrete and constrained by nat...
Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration [0.03%]
一种针对SARS-Cov-2的中和抗体DZIF-10c的人群药代动力学研究：预测吸入给药和静脉输注后的全身暴露和肺暴露的半机制建模
Sree Kurup,Nieves Velez de Mendizabal,Stephan Becker et al.
Sree Kurup et al.
DZIF-10c (BI 767551) is a recombinant human monoclonal antibody of the IgG1 kappa isotype. It acts as a SARS-CoV-2 neutralizing antibody. DZIF-10c has been developed for both systemic exposure by intravenous infusion as well as for specific...