Results 31 to 40 of about 29,972 (265)

Pharmacokinetics, effectiveness and safety of certolizumab pegol in children and adolescents with active juvenile idiopathic arthritis: 9+‐year results from a multicenter, open‐label study

Arthritis &Rheumatology, Accepted Article.
Objective To assess the pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (CZP) in polyarticular‐course juvenile idiopathic arthritis (pcJIA). Methods Pediatric Arthritis Study of Certolizumab Pegol (NCT01550003), a multicenter, open‐label study, enrolled patients 2–17 years with active pcJIA and inadequate response ...
Hermine I Brunner, Lyudmila Grebenkina, Irina Nikishina, Ekaterina Alexeeva, Vyacheslav Chasnyk, Carlos Abud‐Mendoza, Nadina Rubio‐Pérez, Heinrike Schmeling, María del Rocio Maldonado‐Velázquez, Diane Brown, Andrew Zeft, Esi Morgan, C. Egla Rabinovich, Daniel Kingsbury, Hulya Bukulmez, Beth Gottlieb, Thomas Griffin, Lisa Imundo, Stacey Tarvin, Earl Silverman, Laura Shaughnessy, Saori Shimizu, Paulette Williams, Rocío Lledó‐García, Gauri Utturkar, Baran Ufuktepe, Alberto Martini, Daniel Lovell, Nicolino Ruperto   +28 more
wiley   +1 more source

Implementing GCPs in Asia [PDF]

The Quality Assurance Journal, 2000
The implementation of International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) standards in China, Taiwan, Thailand and Japan poses some unique challenges due to cultural influences, particularly in Japan. Auditing experiences were generally positive in all countries with auditing by a Western company being viewed as a positive and ...
openaire   +1 more source

Population pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Canagliflozin was recently approved in type 2 diabetes mellitus (T2DM) patients ≥10 and <18 years old as a single agent dosed once daily (QD) or in a fixed‐dose combination with metformin dosed twice daily (BID). We characterize canagliflozin pharmacokinetics in paediatric patients with T2DM, compare estimated individual and simulated ...
Nele Goeyvaerts, Per Olsson Gisleskog, Martine Neyens, Juan José Perez Ruixo, Saberi Rana Ali, Iolanda Cirillo, Oliver Ackaert   +6 more
wiley   +1 more source

Effect of Gan Cao (Glycyrrhiza uralensis Fisch) polysaccharide on growth performance, immune function, and gut microflora of broiler chickens

Poultry Science, 2022
: Glycyrrhiza uralensis Fisch, also called Gan Cao, is a commonly prescribed herb in traditional Chinese medicine. Gan Cao is associated with immune-modulation and antitumor potential though its mechanism of action is not well-known.
Shouping Zhang, Chunling Zhu, Hongbing Xie, Lriong Wang, Jianhe Hu   +4 more
doaj   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Irradiated mesenchymal stem cells support stemness maintenance of hepatocellular carcinoma stem cells through Wnt/β-catenin signaling pathway

Cell & Bioscience, 2020
Background Cancer stem cells are the main reason of relapse, metastasis and resistance to anti-cancer therapies of Hepatocellular carcinoma (HCC). Mesenchymal stem cells (MSCs) are an important part of the tumor microenvironment.
Jing Hou, Naping Zhao, Pengxi Zhu, Jun Chang, Yan Du, Wei Shen   +5 more
doaj   +1 more source

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

Creating and testing a GCP game in an asynchronous course environment: The game and future plans

Journal of Clinical and Translational Science, 2020
Introduction:The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform.
Carolynn T. Jones, Penelope Jester, Jennifer A. Croker, Jessica Fritter, Cathy Roche, Brian Wallace, Andrew O. Westfall, David T. Redden, James Willig   +8 more
doaj   +1 more source

“How do I keep this live in my mind?” Allied Health Professionals’ perspectives of barriers and enablers to implementing good clinical practice principles in research: a qualitative exploration

BMC Health Services Research, 2023
Background Allied health professionals (AHPs) engaged in research are expected to comply with Good Clinical Practice (GCP) principles to protect participant safety and wellbeing and enhance data integrity.
Rachel Wenke, Shelley Roberts, Rebecca Angus, Maame Amma Owusu, Kelly Weir   +4 more
doaj   +1 more source

Ferritin as a Nanoparticle Scaffold for Plant‐Produced Next‐Generation Subunit Vaccines

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Protein nanoparticles offer an innovative approach to next‐generation subunit vaccine development by displaying antigenic sequences on the nanoparticle surface. Compared to traditional subunit vaccines, protein nanoparticle vaccines often show improved interaction with the immune system due to their particulate size and repetitive epitope ...
Jordan T. VanderBurgt, Richard Strasser, Christopher P. Garnham, Rima Menassa   +3 more
wiley   +1 more source