Results 121 to 130 of about 39,064 (303)

Biosimilars in rheumatology: what the clinician should know

RMD Open, 2015
Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars ...
Jonathan Kay, Gilberto Castañeda-Hernández, Rodrigo González-Ramírez, Morton A Scheinberg   +3 more
doaj   +1 more source

Development of a step‐gradient simulated moving bed process for the polishing of monoclonal antibodies with anion exchange chromatography

Journal of Chemical Technology &Biotechnology, EarlyView.
Abstract BACKGROUND In recent years, biopharmaceutical applications in medicine have seen explosive growth and the need for efficient, rapid and inexpensive purification of these targets is the topic of tremendous research and development. The need to improve process efficiency has been an active area of investigation due to the tremendous potential ...
Yasmina MJ Harsy, Jonas Wege, Anthony Grabski, Romain Dabre, Egbert Müller, Carsten‐René Arlt   +5 more
wiley   +1 more source

Treatment of psoriasis with biologic agents in Malta [PDF]

, 2016
Introduction: Biologic therapy has revolutionalised the treatment of moderate to severe psoriasis leading to improved clinical outcomes and quality of life scores.
Aquilina, Susan, Boffa, Michael J., Clark, Eileen, Mercieca, Liam, Scerri, Lawrence   +4 more
core  

Management of paediatric ulcerative colitis, part 1: Ambulatory care—An updated evidence‐based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation

Journal of Pediatric Gastroenterology and Nutrition, EarlyView.
Abstract Objectives Despite advances in the management of ambulatory paediatric ulcerative colitis (UC), challenges remain as many patients are refractory to therapy and some require colectomy. The aim of these guidelines is to provide an update on optimal care for UC through detailed recommendations and practice points. Methods These guidelines are an
Eytan Wine, Marina Aloi, Stephanie Van Biervliet, Jiri Bronsky, Javier Martín di Carpi, Marco Gasparetto, Laura Gianolio, Hannah Gordon, Iva Hojsak, Alexandra S. Hudson, Séamus Hussey, Johan van Limbergen, Erasmo Miele, Lorenzo Norsa, Ola Olén, Gianluca Pellino, Patrick van Rheenen, Lissy de Ridder, Richard K. Russell, Dror S. Shouval, Eunice Trindade, Dan Turner, David C. Wilson, Anat Yerushalmy Feler, Amit Assa   +24 more
wiley   +1 more source

Clinical considerations for biosimilar antibodies [PDF]

, 2013
Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar ...
Mellstedt, Håkan
core   +1 more source

Recent Advancements in the Treatment of Age‐Related Macular Degeneration

Med Research, EarlyView.
ABSTRACT Age‐related macular degeneration (AMD) is a prevalent cause of visual impairment and blindness among the elderly. AMD can be categorized into two subtypes: “wet” and “dry.” Current treatments for wet AMD mainly involve anti‐vascular endothelial growth factor (VEGF) drugs, and there are three U.S.
Shan Liu, Danyang Lv, Junran Sun, Huixun Jia, Fang Zheng, Felipe Pereira, Siddharth Narendran, Zhenyu Dong, Haiyun Liu, Shunxiang Gao, Peirong Huang   +10 more
wiley   +1 more source

The similarity question for biologicals and non-biological complex drugs [PDF]

, 2015
For small – low molecular weight – molecule medicines a robust regulatory system has evolved over the years. This system guarantees high and constant quality of our (generic) medicines.
Crommelin, Daan J.A., de Vlieger, Jon S.B., Flühmann, Beat, Klebovich, Imre, McNeil, Scott E., Mühlebach, Stefan, Shah, Vinod P., Weinstein, Vera   +7 more
core   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?

Frontiers in Pharmacology, 2019
Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.
D. Baumgart, L. Miséry, S. Naeyaert, P. Taylor   +3 more
semanticscholar   +1 more source

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

Small, EarlyView.
This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora   +5 more
wiley   +1 more source