Results 41 to 50 of about 503,948 (102)

Host Cell Protein Clinical Safety Risk Assessment—An Updated Industry Review

Biotechnology and Bioengineering, Volume 122, Issue 11, Page 3229-3248, November 2025.
ABSTRACT Host cell proteins (HCP) are process‐related impurities that can co‐purify with therapeutic proteins. Some HCP impurities potentially can have an impact on patient safety (immunogenicity or toxicity), efficacy, and/or product quality. It is important to reduce the levels of HCP impurities with a well‐controlled manufacturing process and to ...
Lisette Coye, Marisa A. Jones, Georgeen Gaza‐Bulseco, Carmelata Chitikila, Severine Clavier, Delphine Fougeron, Christine Grimaldi, Karen Hurkmans, Richard Hutchinson, Brenda Kellogg, Xinrong Liu, Nisha Palackal, Mahima Tank, Pascal Valax, Thomas Waerner, Fengqiang Wang, Ying Zhang, Yiwei Zhao, Sapphire Sloan, Christina Zuch de Zafra   +19 more
wiley   +1 more source

Inhalation characteristics of asthma patients, COPD patients and healthy volunteers with the Spiromax® and Turbuhaler® devices: a randomised, cross-over study. [PDF]

, 2015
BACKGROUND: Spiromax® is a novel dry-powder inhaler containing formulations of budesonide plus formoterol (BF). The device is intended to provide dose equivalence with enhanced user-friendliness compared to BF Turbuhaler® in asthma and chronic ...
Philip Chetcuti, Hosker, Harold, Chrystyn, Henry, Azouz, Wahida, Saralaya, Dinesh, Dinesh Saralaya, Chetcuti, Philip, Wahida Azouz, Henry Chrystyn, Harold Hosker   +9 more
core   +2 more sources

Jacobsen Syndrome: A Case Report With Olfactory Bulb Agenesis, Severe Endocrinopathy, and Neurodevelopmental Delay

Clinical Case Reports, Volume 13, Issue 10, October 2025.
ABSTRACT Jacobsen syndrome is a rare 11q deletion disorder with multisystem involvement. This case highlights a complex unbalanced 11;15 translocation, olfactory bulb agenesis, extensive white matter abnormalities, and severe endocrinopathies, emphasizing the need for comprehensive genetic and neuroimaging evaluations.
Sajjad Ghanim Al‐Badri, Aditya Duhan, Rania H. Al‐Taie, Muntadher Yousif Hasan Al Gehadi, Ibrahim Khalil   +4 more
wiley   +1 more source

A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China

Clinical Endocrinology, Volume 102, Issue 2, Page 136-146, February 2025.
ABSTRACT Objective Children born small for gestational age (SGA) are at increased risk of health issues. This study evaluated the efficacy, safety and optimal dose of PEGylated‐recombinant human growth hormone (PEG‐rhGH) in these children. Design In this multicentre, randomised, open‐label, Phase 2 trial conducted at nine clinical sites in China ...
Xiaoping Luo, Ling Hou, Yan Zhong, Sha Zhao, Xiaobo Chen, Qian Dong, Hongwei Du, Honghua Lu, Yu Yang, Xian Wu, Feihong Luo, Ruoqian Chen, Zhuangjian Xu, Yaping Ma, Wenhui Song, Mei Feng, Xuefan Gu, Wenjuan Qiu   +17 more
wiley   +1 more source

What is the prevalence of anabolic‐androgenic steroid use among women? A systematic review

Addiction, Volume 119, Issue 12, Page 2088-2100, December 2024.
Abstract Background and aim Evidence suggests there has been an increase in anabolic‐androgenic steroid (AAS) use among women, driven by the evolving landscape of women's participation in sport. However, the extent of use is unknown. This systematic review aimed to estimate the prevalence of women's AAS use.
Timothy Piatkowski, Bianca Whiteside, Jonathan Robertson, April Henning, Eric H. Y. Lau, Matthew Dunn   +5 more
wiley   +1 more source

Ten years of biosimilar recombinant human growth hormone in Europe

Drug Design, Development and Therapy, 2017
Paul Saenger Division of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA Abstract: Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years.
Saenger P
doaj  

Letters to the Editor

, 2014
Canadian Journal of Gastroenterology and Hepatology, Volume 28, Issue 8, Page 452-454, 2014.
Miklos Sebeszta, Alex Kudrin
wiley   +1 more source

Overview of Subsequent Entry Biologics for the Management of Inflammatory Bowel Disease and Canadian Association of Gastroenterology Position Statement on Subsequent Entry Biologics

, 2013
Canadian Journal of Gastroenterology and Hepatology, Volume 27, Issue 10, Page 567-571, 2013.
Shane M Devlin, Brian Bressler, Charles N Bernstein, Richard N Fedorak, Alain Bitton, Harminder Singh, Brian G Feagan   +6 more
wiley   +1 more source

Ten years of biosimilars in Europe: development and evolution of the regulatory pathways

Drug Design, Development and Therapy, 2017
Martin Schiestl,1 Markus Zabransky,2 Fritz Sörgel3,4 1Sandoz GmbH, Kundl, Austria; 2Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, Germany; 3Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany; 4Institute of ...
Schiestl M, Zabransky M, Sörgel F
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, 2014
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core   +1 more source