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...
Translational population target binding model for the anti-FcRn fragment antibody efgartigimod [0.03%]
用于抗FcRn片段抗体efgartigimod的靶点结合人群转化模型
Sven Hoefman,Tamara van Steeg,Ingrid Ottevaere et al.
Sven Hoefman et al.
Efgartigimod is a human IgG1 antibody Fc-fragment that lowers IgG levels through blockade of the neonatal Fc receptor (FcRn) and is being evaluated for the treatment of patients with severe autoimmune diseases mediated by pathogenic IgG aut...
Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulations [0.03%]
器官芯片集成系统在肿瘤药物 PKPD 模型和仿真中的应用研究
Abdurehman Eshete Mohammed,Filiz Kurucaovalı,Devrim Pesen Okvur
Abdurehman Eshete Mohammed
Cancer is one of the most common and fatal diseases worldwide and kills millions of people every year. Cancer drug resistance, lack of efficacy, and safety are significant problems in cancer patients. A multiorgan-on-a-chip (MOC) device con...
In memory of Dr. Thomas M. Ludden: a pioneer in pharmacometrics, a mentor to many, and a legacy of compassionate science [0.03%]
缅怀托马斯·M·卢登博士：药代动力学的先驱、良师益友和富有同情心的科学精神的典范
Steve Riley,Joan Korth-Bradley,Robert J Bauer et al.
Steve Riley et al.