Results 131 to 140 of about 91,611 (307)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Toward personalized healthcare: Advances in two‐dimensional nanomaterial‐based flexible electrochemical sensors for physiological monitoring

BMEMat, EarlyView.
This review provides an overview of the properties, composites and application of two‐dimensional (2D) nanomaterials for wearable electrochemical biosensors. Also, the challenges and future prospects of utilizing 2D nanomaterials in wearable electrochemical biosensor applications are discussed.
Kou Zhang, Lu Han, He‐Qing Cai, Xin‐Yu Xue, Yi‐Fei Song, Wu‐Lin Xin, Ying‐Ze Wang, Peng Liu, Juan Liu   +8 more
wiley   +1 more source

Predicting Coronary Occlusion Risk during Redo‐TAVR at First TAVR: Asymmetric Calcification Causes Failure

Catheterization and Cardiovascular Interventions, EarlyView.
ABSTRACT Background and Aims Predicting coronary artery occlusion due to sinus sequestration (SS) during a second transcatheter aortic valve (TAV) procedure using pre‐procedural computed tomography (CT) after the first TAV replacement (TAVR) is underreported.
Kyohei Onishi, Masakazu Yasuda, Nobuhiro Yamada, Naoko Soejima, Ayano Yoshida, Kosuke Fujita, Hiroki Matsuzoe, Tatsuya Miyoshi, Koichiro Matsumura, Kazuki Mizutani, Masafumi Ueno, Genichi Sakaguchi, Gaku Nakazawa   +12 more
wiley   +1 more source

Advances in Parahydrogen‐Induced Polarization for Nuclear Magnetic Resonance of Peptides, Proteins, and Biopolymers

ChemistryEurope, EarlyView.
Hyperpolarization by parahydrogen‐induced polarization enhances the sensitivity of nuclear magnetic resonance spectroscopy of amino acids, peptides, mini‐proteins, and biopolymers using nonnatural amino acids with unsaturated side chains up to three orders of magnitude.
Gerd Buntkowsky
wiley   +1 more source

Chemical engineering as an essential element of industrial biotechnology in Mexico: New aims in research and university education

The Canadian Journal of Chemical Engineering, EarlyView.
Abstract On the centennial of higher education in Chemical Engineering in Mexico, it is pertinent to revisit the key stages that have contributed to its consolidation as a vital discipline for the nation's scientific and technological advancement. Although the initial mission of chemical engineering education was primarily oriented toward the training ...
Agustín López Munguía, Octavio T. Ramírez, Rafael Vazquez‐Duhalt, Eduardo Bárzana   +3 more
wiley   +1 more source

Engineering Lipid Nanoparticles for Precision RNA Delivery: Design Principles, Targeting Strategies, and Clinical Prospects

Cancer Nexus, EarlyView.
ABSTRACT Lipid nanoparticles (LNPs) represent the most clinically advanced platform for RNA delivery and have enabled major breakthroughs in vaccines and gene therapies. However, their broader application is still limited by inefficient extrahepatic delivery, immunogenicity, and insufficient control over tissue‐ and cell‐specific targeting. This review
Yu Han, Ying Wang, Xintao Gao, Yan Lei, Yantao Li, Zhiyong Tang   +5 more
wiley   +1 more source

Nanoparticles in microdroplets: Recent advances in microfluidic generators for producing functional microbeads

Droplet, EarlyView.
Functional hybrid microbeads with electrical, magnetic, and/or optical responsiveness have emerged as versatile platforms for biotechnology. This review highlights recent advances in microfluidic technologies for producing such microbeads, with a focus on incorporating functional nanoparticles in microdroplet systems.
  Bayinqiaoge, Chengchen Zhang, Shi‐Yang Tang   +2 more
wiley   +1 more source

Targeting Hsp90 with cemdomespib reduces seizure burden and alters disease course in preclinical epilepsy models

Epilepsia, EarlyView.
Abstract Objective Epilepsy is a chronic neurological disorder characterized by recurrent seizures and frequent cognitive and psychiatric comorbidities. Although current antiseizure medications provide symptomatic relief, they fail to prevent or modify epileptogenesis.
Yara Sheeni, Prince Kumar Singh, Sereen Sandouka, Taige Zhang, Alina Nemirovski, Aseel Saadi, Rhoda Olowe Taiwo, Matthew C. Walker, Tawfeeq Shekh‐Ahmad   +8 more
wiley   +1 more source

L‐Relationship between uncertainty and average seizure frequency in clinical trials of antiseizure medications

Epilepsia, EarlyView.
Abstract Objective Antiseizure medications are approved based on clinical trials that demonstrate their efficacy as measured by reductions in seizure frequency (SF). When designing these trials, trialists must select inclusion criteria where SF can be reliably measured to maintain statistical power.
Wesley T. Kerr, Neo Kok, Katherine N. McFarlane, Advith S. Reddy, Lavanya Biju, Jacqueline A. French, Daniel M. Goldenholz   +6 more
wiley   +1 more source

Evolution of the European Medicines Agency clinical guidelines for epilepsy drug development between 2010 and 2025: A comparative analysis by the ILAE Task Force on Regulatory Affairs

Epilepsia, EarlyView.
Abstract Objective The latest European Medicines Agency (EMA) guideline on the clinical investigation of medicines to treat epileptic disorders was adopted by the EMA Committee for Medicinal Products for Human Use in 2025. We compared this guideline with the previous version (2010), highlighting areas where significant revisions were introduced ...
Stéphane Auvin, Alexis Arzimanoglou, Jacqueline French, Kelly G. Knupp, Lieven Lagae, Eugen Trinka, Dennis Dlugos, Emilio Perucca   +7 more
wiley   +1 more source