Brain organoids in Parkinson's disease drug development: Human-specific models for translational discovery [0.03%]
帕金森病药物研发中的大脑类器官：人类特异性模型的转化发现
Alise Zagare,Javier Jarazo,Jens Schwamborn
Alise Zagare
Parkinson's disease (PD) poses a major unmet therapeutic challenge, with most drug candidates failing in clinical translation despite promising animal model data. Human induced pluripotent stem cell-derived midbrain organoids recapitulate k...
Single Pivotal Trials as the Default in FDA Drug Approvals: Variation and Guardrails [0.03%]
单一主要试验作为FDA药品审批的默认方法：变化与边界条件
Siqi Wang,Xuejing Zhang,Yuan Fang et al.
Siqi Wang et al.
The platform technology approach in the EU regulation of medicines for human use: Stakeholder perspectives on its definition and implementation [0.03%]
欧盟人类药品平台技术监管的多方视角：定义与实施中的问题探讨
Stephanie M P Oskam,Lourens T Bloem,Marcel H N Hoefnagel et al.
Stephanie M P Oskam et al.
The upcoming revised European Union (EU) general pharmaceutical legislation will incorporate the concept of the platform technology approach. Based on focus group discussions, we provide perspectives on the definition and implementation of ...
Analysis of FDA approvals, delays and denials of new drug applications, 2013-2023 [0.03%]
2013年至2023年美国FDA新药申请的审批、延期和拒绝分析
Gemma McCarthy,Niamh M O&#x;Boyle
Gemma McCarthy
Timely approval of New Molecular Entities (NMEs) is central to patient access and innovation. We analysed small molecule NME submissions reviewed by the US Food and Drug Administration (FDA) between 2013 and 2023. New Drug Applications (NDA...
Turning animal-study administration signals into drug-development intelligence [0.03%]
将动物研究管理信号转化为药物研发情报
Carlos Victor Montefusco-Pereira,Howard Lopes Ribeiro Junior
Carlos Victor Montefusco-Pereira
Nano alchemy: Ionic liquids transforming metallic particles for medicine [0.03%]
纳米炼金术：离子液体通过转化金属颗粒用于医学
Azad Bharti,Anuja Muley,Shubham Mule et al.
Azad Bharti et al.
The combination of ionic liquid (IL) and metallic nanoparticles (MNPs) provides an attractive framework for developing multifunctional nanomaterials that have substantial pharmaceutical and therapeutic applications. ILs, mainly composed of ...
Reassessing galectin inhibition: Lessons for context-selective drug design and translational oncology [0.03%]
从转化肿瘤学的角度审视乳糖凝集素抑制：上下文选择性药物设计的启示
Yves St-Pierre
Yves St-Pierre
Although the role of galectins in tumor progression is well established, this knowledge has not translated into significant clinical advances, reflecting challenges in targeting multifunctional, context-dependent proteins. We revisit this d...
Pharmacological modulation of ATF6: exploiting a stress-integrative node to overcome drug resistance [0.03%]
药理学调节ATF6：开发一个克服耐药性的应激整合节点
Saeid Ghavami,Mahmood Aghaei
Saeid Ghavami
Activating transcription factor 6 (ATF6), a major arm of the unfolded protein response (UPR), functions as an integrative regulator of cellular adaptation. Beyond proteostasis, ATF6 coordinates redox balance, autophagy, apoptosis, and lipid...
Olga Volkova,Anastasia Serova,Ekaterina Skorb et al.
Olga Volkova et al.
This review highlights the quartz crystal microbalance (QCM) as a powerful tool for label-free, real-time analysis of biomolecular interactions, with a specific focus on protein-ligand binding in drug discovery. It underscores the unique se...
Validation of AI-enabled surrogate models in quantitative systems pharmacology: a practical, context-of-use-driven review [0.03%]
基于使用的定量系统药理学中AI使能代理模型的验证：实用的语境驱动回顾
Igor Goryanin,Irina Goryanin
Igor Goryanin
Quantitative systems pharmacology (QSP) models support model-informed drug development but are computationally expensive, limiting workflows requiring many simulations. Artificial intelligence (AI)-enabled surrogates can accelerate these wo...