Results 141 to 150 of about 332,661 (303)

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Glycoengineered Recombinant Alpha1‐Antitrypsin Results in Comparable In Vitro and In Vivo Activities to Human Plasma‐Derived Protein

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Alpha‐1‐antitrypsin (A1AT) is a multifunctional, clinically important, high‐value therapeutic glycoprotein that can be used for the treatment of many diseases, such as A1AT deficiency, diabetes, graft‐versus‐host disease, cystic fibrosis, and various viral infections. Currently, the only U.S. food and drug administration‐approved treatment for
Frances Rocamora, Chen‐Lin Hsieh, Sanne Schoffelen, Johnny Arnsdorf, Eric A. Toth, Abdul S. Yunus, Thomas E. Cleveland IV, Sara Petersen Bjørn, Mina Ying Min Wu, Noel G. McElvaney, Bjørn Gunnar Rude Voldborg, Thomas R. Fuerst, Nathan E. Lewis   +12 more
wiley   +1 more source

Purification of Advanced Therapeutics by Flow‐Through Pseudo‐Affinity Chromatography: Bi‐Specific mABs, Fc Fusion Proteins, and Adeno‐Associated Viruses

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Modern biopharmaceutical manufacturing requires purification platforms capable of processing structurally and functionally diverse products while addressing the challenge of removing persistent and high‐risk host cell proteins (HCPs).
Wenning Chu, Eduardo Barbieri, Arianna Minzoni, Shriarjun Shastry, Jacob P. LeBarre, Qingbo Shu, Taufika Williams, Xuanwen Li, Divya Chandra, Xuankuo Xu, Jerome Bill, David Roush, Joseph Taris, Patrick Gilbert, Andre Kiesewetter, Oliver Rammo, Michael Schulte, Christopher Major, Trina Mouchahoir, Steven Cramer, Cristiana Boi, Ruben G. Carbonell, Abraham Lenhoff, Stefano Menegatti   +23 more
wiley   +1 more source

Neurovascular coupling in bone regeneration: Mechanisms, advanced biomaterials and challenges

BMEMat, EarlyView.
This figure illustrates various material strategies for neurovascularized bone regeneration, including electroactive scaffolds, ion‐loaded materials, drug delivery systems, surface modifications, cells/cell products, growth factors, and peptides. These approaches aim to synergistically promote the regeneration of neural, vascular, and bone tissues ...
Yixin Ma, Nan Jiang, Liyuan Chen, He Zhang, Xinjia Cai, Karan Gulati, Danqing He, Zhigang Cai, Yan Liu   +8 more
wiley   +1 more source

Optimized micro‐sized cell sphere‐matrix niche co‐aggregates promote efficient oral and craniomaxillofacial bone regeneration

BMEMat, EarlyView.
The construct of cell‐niche co‐aggregates (GelMA‐SHED sphere‐DDMPs) promotes cranial and periodontal bone regeneration and ensures angiogenic‐osteogenic coupling by downregulating miR‐34c‐5p to enhance the expression of NOTCH1 and its intracellular domain (NICD).
Xiao‐Hui Zhang, Shi‐Han Mu, Yi‐Han Xiao, Lu‐Fan Yang, Peng‐Fei Wang, Teng‐Fei Hu, Jun‐Xi He, Jiong‐Zhen Piao, Sha Zhang, Jin‐Yu Liu, Yi‐De He, Ying‐Ying Wu, Si‐Qi Ying, Xin‐Yue Cai, Chen‐Han Li, Zi‐Qi Zhang, Xiao Lei, Ji Chen, Jian‐Fei Liang, Yan Jin, Bing‐Dong Sui, Chao Ma, Chen‐Xi Zheng, Fang Jin   +23 more
wiley   +1 more source

Metal nanostructure‐coupled label‐free localized surface plasmon resonance biosensors for rapid and sensitive disease diagnosis

BMEMat, EarlyView.
LSPR biosensing enables rapid, sensitive, and low‐sample‐volume detection of biomarkers, with broad applications in diagnosing cancer, infectious, and chronic diseases. Advances in nanostructure design, micro/nanofabrication, and microfluidic integration have expanded the potential of LSPR sensors in biomedical diagnostics.
Zhaoxin Geng, Yunfei Sha, Jiongyan Yang, Hongru Yang, Xiao Liang   +4 more
wiley   +1 more source

Mechanism study of an articular cartilage repair material and its forward‐looking test for space medicine

BMEMat, EarlyView.
The regeneration process following dLhCG engraftment progressed through four distinct and interconnected stages. dLhCG maintained its regenerative efficacy after 6 months of cosmic exposure, supporting its potential application in space medicine.
Xu Hu, Hang Yao, Zhen Zhang, Zhonglian Wu, Huiqun Zhou, Bangheng Liu, Liang Ma, Yulei Mu, Dong‐An Wang   +8 more
wiley   +1 more source

Radial Versus Femoral Access for Diagnostic Coronary Angiography: Insights From a Tertiary Academic Center in Johannesburg

Catheterization and Cardiovascular Interventions, EarlyView.
ABSTRACT Background The radial artery is the preferred access for performing diagnostic coronary angiograms (DCA). However, data on the safety and efficacy of radial compared to femoral access in low‐ and middle‐income countries is limited. Aims This study aims to evaluate the safety and efficacy of radial versus femoral access in patients referred for
Khulasande Liso Ntaka, Dineo Mpanya, Umar G Adamu, Thomas Kalk, Nqoba Tsabedze   +4 more
wiley   +1 more source

Azithromycin for Prevention of Graft-Versus-Host Disease: A Randomized Placebo-Controlled Trial

International Journal of Hematology-Oncology and Stem Cell Research, 2018
Background: Allogeneic hematopoietic stem cell transplantation has been used widely to treat various types of malignant and non-malignant disorders. Graft-versus-host disease is one of the main complications of this procedure which is associated with ...
Maryam Barkhordar, Mehdi Mohammadi, Ahmad Reza Shamshiri, Molouk Hadjibabaie, Ardeshir Ghavamzadeh   +4 more
doaj  

Fungal Antimicrobial Resistance: Mechanisms, Drivers, and Global Clinical Burden

ChemFoodChem, EarlyView.
ABSTRACT Fungal antimicrobial resistance (AMR) is a growing concern for world health caused by an increase in multidrug‐resistant infections, an increase in environmental reservoirs, and the ineffectiveness of current antifungal treatments. Fungal infections continue to be largely excluded from AMR initiatives while causing over 1.6 million deaths ...
Bikash Baral
wiley   +1 more source