Advanced drug delivery reviews最新文献_第2页

Current status and challenges of model-informed drug discovery and development in China 中国基于模型的药物研发现状与挑战

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-10-09 DOI: 10.1016/j.addr.2024.115459

Yuzhu Wang , Jia Ji , Ye Yao , Jing Nie , Fengbo Xie , Yehua Xie , Gailing Li

{"title":"Current status and challenges of model-informed drug discovery and development in China","authors":"Yuzhu Wang , Jia Ji , Ye Yao , Jing Nie , Fengbo Xie , Yehua Xie , Gailing Li","doi":"10.1016/j.addr.2024.115459","DOIUrl":"10.1016/j.addr.2024.115459","url":null,"abstract":"<div><div>In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China’s evolving pharmaceutical landscape.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115459"},"PeriodicalIF":15.2,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142386042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Recent applications of three-dimensional bioprinting in drug discovery and development 三维生物打印在药物研发中的最新应用。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-09-19 DOI: 10.1016/j.addr.2024.115456

Kaixing Yang , Lingxin Wang , Sanjairaj Vijayavenkataraman , Yunong Yuan , Edwin C.K. Tan , Lifeng Kang

{"title":"Recent applications of three-dimensional bioprinting in drug discovery and development","authors":"Kaixing Yang , Lingxin Wang , Sanjairaj Vijayavenkataraman , Yunong Yuan , Edwin C.K. Tan , Lifeng Kang","doi":"10.1016/j.addr.2024.115456","DOIUrl":"10.1016/j.addr.2024.115456","url":null,"abstract":"<div><div>The ability of three-dimensional (3D) bioprinting to fabricate biomimetic organ and disease models has been recognised to be promising for drug discovery and development as 3D bioprinted models can better mimic human physiology compared to two-dimensional (2D) cultures and animal models. This is useful for target selection where disease models can be studied to understand disease pathophysiology and identify disease-linked compounds. Lead identification and preclinical studies also benefit from 3D bioprinting as 3D bioprinted models can be utilised in high-throughput screening (HTS) systems and to produce efficacy and safety data that closely resembles clinical observations. Although no published applications of 3D bioprinting in clinical trials were found, there are two clinical trials planning to evaluate the predictive ability of 3D bioprinted models by comparing human and model responses to the same chemotherapy. Overall, this review provides a comprehensive summary of the latest applications of 3D bioprinting in drug discovery and development.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115456"},"PeriodicalIF":15.2,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

RNA-loaded nanoparticles for the treatment of hematological cancers 用于治疗血液肿瘤的 RNA 载体纳米粒子

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-09-18 DOI: 10.1016/j.addr.2024.115448

Elisa Garbayo , Souhaila H. El Moukhtari , Carlos Rodríguez-Nogales , Xabier Agirre , Juan R. Rodriguez-Madoz , Paula Rodriguez-Marquez , Felipe Prósper , Patrick Couvreur , María J. Blanco-Prieto

{"title":"RNA-loaded nanoparticles for the treatment of hematological cancers","authors":"Elisa Garbayo , Souhaila H. El Moukhtari , Carlos Rodríguez-Nogales , Xabier Agirre , Juan R. Rodriguez-Madoz , Paula Rodriguez-Marquez , Felipe Prósper , Patrick Couvreur , María J. Blanco-Prieto","doi":"10.1016/j.addr.2024.115448","DOIUrl":"10.1016/j.addr.2024.115448","url":null,"abstract":"<div><p>Hematological cancers encompass a diverse group of malignancies affecting the blood, bone marrow, lymph nodes, and spleen. These disorders present unique challenges due to their complex etiology and varied clinical manifestations. Despite significant advancements in understanding and treating hematological malignancies, innovative therapeutic approaches are continually sought to enhance patient outcomes.</p><p>This review highlights the application of RNA nanoparticles (RNA-NPs) in the treatment of hematological cancers. We delve into detailed discussions on <em>in vitro</em> and preclinical studies involving RNA-NPs for adult patients, as well as the application of RNA-NPs in pediatric hematological cancer. The review also addresses ongoing clinical trials involving RNA-NPs and explores the emerging field of CAR-T therapy engineered by RNA-NPs. Finally, we discuss the challenges still faced in translating RNA-NP research to clinics.</p></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115448"},"PeriodicalIF":15.2,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0169409X24002709/pdfft?md5=394e09e402e81b0f66099b1b06ffb9f2&pid=1-s2.0-S0169409X24002709-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142271869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Breaking the final barrier: Evolution of cationic and ionizable lipid structure in lipid nanoparticles to escape the endosome 打破最后的障碍：脂质纳米颗粒中阳离子和可电离脂质结构的演变，以逃离内质体。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-09-16 DOI: 10.1016/j.addr.2024.115446

Kaitlin Mrksich , Marshall S. Padilla , Michael J. Mitchell

{"title":"Breaking the final barrier: Evolution of cationic and ionizable lipid structure in lipid nanoparticles to escape the endosome","authors":"Kaitlin Mrksich , Marshall S. Padilla , Michael J. Mitchell","doi":"10.1016/j.addr.2024.115446","DOIUrl":"10.1016/j.addr.2024.115446","url":null,"abstract":"<div><div>In the past decade, nucleic acid therapies have seen a boon in development and clinical translation largely due to advances in nanotechnology that have enabled their safe and targeted delivery. Nanoparticles can protect nucleic acids from degradation by serum enzymes and can facilitate entry into cells. Still, achieving endosomal escape to allow nucleic acids to enter the cytoplasm has remained a significant barrier, where less than 5% of nanoparticles within the <em>endo</em>-lysosomal pathway are able to transfer their cargo to the cytosol. Lipid-based drug delivery vehicles, particularly lipid nanoparticles (LNPs), have been optimized to achieve potent endosomal escape, and thus have been the vector of choice in the clinic as demonstrated by their utilization in the COVID-19 mRNA vaccines. The success of LNPs is in large part due to the rational design of lipids that can specifically overcome endosomal barriers. In this review, we chart the evolution of lipid structure from cationic lipids to ionizable lipids, focusing on structure–function relationships, with a focus on how they relate to endosomal escape. Additionally, we examine recent advancements in ionizable lipid structure as well as discuss the future of lipid design.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115446"},"PeriodicalIF":15.2,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142278760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Editorial: Super-resolution imaging of sub-cellular dynamics of drug molecules. 药物分子亚细胞动态超分辨率成像。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-09-14 DOI: 10.1016/j.addr.2024.115455

Qixin Chen, Jiajie Diao

引用次数: 0

Application of MIDD to accelerate the development of anti-infectives: Current status and future perspectives 应用 MIDD 加速抗感染药物的开发：现状与未来展望

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-09-12 DOI: 10.1016/j.addr.2024.115447

Wen Yao Mak , Qingfeng He , Wenyu Yang , Nuo Xu , Aole Zheng , Min Chen , Jiaying Lin , Yufei Shi , Xiaoqiang Xiang , Xiao Zhu

{"title":"Application of MIDD to accelerate the development of anti-infectives: Current status and future perspectives","authors":"Wen Yao Mak , Qingfeng He , Wenyu Yang , Nuo Xu , Aole Zheng , Min Chen , Jiaying Lin , Yufei Shi , Xiaoqiang Xiang , Xiao Zhu","doi":"10.1016/j.addr.2024.115447","DOIUrl":"10.1016/j.addr.2024.115447","url":null,"abstract":"<div><p>This review examines the role of model-informed drug development (MIDD) in advancing antibacterial and antiviral drug development, with an emphasis on the inclusion of host system dynamics into modeling efforts. Amidst the growing challenges of multidrug resistance and diminishing market returns, innovative methodologies are crucial for continuous drug discovery and development. The MIDD approach, with its robust capacity to integrate diverse data types, offers a promising solution. In particular, the utilization of appropriate modeling and simulation techniques for better characterization and early assessment of drug resistance are discussed. The evolution of MIDD practices across different infectious disease fields is also summarized, and compared to advancements achieved in oncology. Moving forward, the application of MIDD should expand into host system dynamics as these considerations are critical for the development of “live drugs” (e.g. chimeric antigen receptor T cells or bacteriophages) to address issues like antibiotic resistance or latent viral infections.</p></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115447"},"PeriodicalIF":15.2,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142242878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effects of nanoparticle deformability on multiscale biotransport 纳米粒子变形性对多尺度生物传输的影响

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-08-31 DOI: 10.1016/j.addr.2024.115445

Hytham H. Gadalla , Zhongyue Yuan , Ziang Chen , Faisal Alsuwayyid , Subham Das , Harsa Mitra , Arezoo M. Ardekani , Ryan Wagner , Yoon Yeo

{"title":"Effects of nanoparticle deformability on multiscale biotransport","authors":"Hytham H. Gadalla , Zhongyue Yuan , Ziang Chen , Faisal Alsuwayyid , Subham Das , Harsa Mitra , Arezoo M. Ardekani , Ryan Wagner , Yoon Yeo","doi":"10.1016/j.addr.2024.115445","DOIUrl":"10.1016/j.addr.2024.115445","url":null,"abstract":"<div><p>Deformability is one of the critical attributes of nanoparticle (NP) drug carriers, along with size, shape, and surface properties. It affects various aspects of NP biotransport, ranging from circulation and biodistribution to interactions with biological barriers and target cells. Recent studies report additional roles of NP deformability in biotransport processes, including protein corona formation, intracellular trafficking, and organelle distribution. This review focuses on the literature published in the past five years to update our understanding of NP deformability and its effect on NP biotransport. We introduce different methods of modulating and evaluating NP deformability and showcase recent studies that compare a series of NPs in their performance in biotransport events at all levels, highlighting the consensus and disagreement of the findings. It concludes with a perspective on the intricacy of systematic investigation of NP deformability and future opportunities to advance its control toward optimal drug delivery.</p></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"213 ","pages":"Article 115445"},"PeriodicalIF":15.2,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142118759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Model-informed precision dosing: State of the art and future perspectives 基于模型的精确配料：技术现状与未来展望。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-08-17 DOI: 10.1016/j.addr.2024.115421

I.K. Minichmayr , E. Dreesen , M. Centanni , Z. Wang , Y. Hoffert , L.E. Friberg , S.G. Wicha

{"title":"Model-informed precision dosing: State of the art and future perspectives","authors":"I.K. Minichmayr , E. Dreesen , M. Centanni , Z. Wang , Y. Hoffert , L.E. Friberg , S.G. Wicha","doi":"10.1016/j.addr.2024.115421","DOIUrl":"10.1016/j.addr.2024.115421","url":null,"abstract":"<div><div>Model-informed precision dosing (MIPD) stands as a significant development in personalized medicine to tailor drug dosing to individual patient characteristics. MIPD moves beyond traditional therapeutic drug monitoring (TDM) by integrating mathematical predictions of dosing, and considering patient-specific factors (patient characteristics, drug measurements) as well as different sources of variability. For this purpose, rigorous model qualification is required for the application of MIPD in patients. This review delves into new methods in model selection and validation, also highlighting the role of machine learning in improving MIPD, the utilization of biosensors for real-time monitoring, as well as the potential of models integrating biomarkers for efficacy or toxicity for precision dosing. The clinical evidence of TDM and MIPD is discussed for various medical fields including infection medicine, oncology, transplant medicine, and inflammatory bowel diseases, thereby underscoring the role of pharmacokinetics/pharmacodynamics and specific biomarkers. Further research, particularly randomized clinical trials, is warranted to corroborate the value of MIPD in enhancing patient outcomes and advancing personalized medicine.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"215 ","pages":"Article 115421"},"PeriodicalIF":15.2,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Drug delivery strategies for local immunomodulation in transplantation: Bridging the translational gap 移植中局部免疫调节的给药策略：缩小转化差距。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-08-13 DOI: 10.1016/j.addr.2024.115429

Afsana Naaz , Heth R. Turnquist , Vijay S. Gorantla , Steven R. Little

引用次数: 0

Advances in the design and delivery of RNA vaccines for infectious diseases 设计和提供治疗传染病的 RNA 疫苗的进展。

IF 15.2 1区医学

Advanced drug delivery reviews Pub Date : 2024-08-05 DOI: 10.1016/j.addr.2024.115419

Abhijeet Girish Lokras , Thomas Rønnemoes Bobak , Saahil Sandeep Baghel , Federica Sebastiani , Camilla Foged

{"title":"Advances in the design and delivery of RNA vaccines for infectious diseases","authors":"Abhijeet Girish Lokras , Thomas Rønnemoes Bobak , Saahil Sandeep Baghel , Federica Sebastiani , Camilla Foged","doi":"10.1016/j.addr.2024.115419","DOIUrl":"10.1016/j.addr.2024.115419","url":null,"abstract":"<div><p>RNA medicines represent a paradigm shift in treatment and prevention of critical diseases of global significance, <em>e.g.</em>, infectious diseases. The highly successful messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed at record speed during the coronavirus disease 2019 pandemic. A consequence of this is exceptionally shortened vaccine development times, which in combination with adaptability makes the RNA vaccine technology highly attractive against infectious diseases and for pandemic preparedness. Here, we review state of the art in the design and delivery of RNA vaccines for infectious diseases based on different RNA modalities, including linear mRNA, self-amplifying RNA, <em>trans</em>-amplifying RNA, and circular RNA. We provide an overview of the clinical pipeline of RNA vaccines for infectious diseases, and present analytical procedures, which are paramount for characterizing quality attributes and guaranteeing their quality, and we discuss future perspectives for using RNA vaccines to combat pathogens beyond SARS-CoV-2.</p></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"213 ","pages":"Article 115419"},"PeriodicalIF":15.2,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0169409X24002412/pdfft?md5=d95ea72925743ff2f59eadf7fc5ec9a0&pid=1-s2.0-S0169409X24002412-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141900597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0