Results 81 to 90 of about 25,471 (263)

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study

International Journal of Circumpolar Health, 2020
Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.
G. G. Alvarez, D. Van Dyk, R. Mallick, S. Lesperance, P. Demaio, S. Finn, S. Edmunds Potvin, M. Patterson, C. Pease, K. Amaratunga, C. Hui, D.W. Cameron, S. Mulpuru, S.D. Aaron, F. Momoli, A. Zwerling   +15 more
doaj   +1 more source

MGBase: A Global, Observational Registry for Collaborative Research in Myasthenia Gravis

Muscle &Nerve, EarlyView.
ABSTRACT Introduction/Aims Patient registries are valuable tools for outcomes research in rare diseases such as myasthenia gravis (MG). Existing MG registries are limited by factors including a lack of geographical scope. MGBase has been designed as a global, observational registry aimed at studying clinical practice outcomes in MG.
Katherine A. Buzzard, Anneke Van der Walt, Helmut Butzkueven, Wen Wen Zhang, Carolina Barnett‐Tapia, Gary Cutter, Jeannine M. Heckmann, Pamela Farr, Carolyn Tran, Charlotte Sartori, Dusko Stupar, Rein More, Linda Sim, Alison Le, Qingxiao Tang, Stephen W. Reddel, the MGBase Study Group, Stefan Blum, Gabvor Lovas, Pamela McCombe, Elisabeth Chroni, Belinda Cruse, Raed Alroughani, John Tzartos, Enrique Gomex‐Figueroa, Cavit Boz, Guntis Karelis, Allan Kermode, Nicholas Crump   +28 more
wiley   +1 more source

Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Clinical and Translational Science, 2019
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies ...
Tomoko Kawamura Okubo, Shunsuke Ono
doaj   +1 more source

Commentary: Use of registries to investigate the past and develop the future. [PDF]

, 2011
International audienceIdeally, collection of clinical data should be an integral part of healthcare systems. Without systematic collection of individual patient data and outcome it is impossible for individual doctors, healthcare providers, or regulatory
Daubert, Jean-Claude, James, Stefan, van de Werf, Frans   +2 more
core   +2 more sources

Postmarketing Assessment of Antibody–Drug Conjugates: Proof‐of‐Concept Using Model‐Based Meta‐Analysis and a Clinical Utility Index Approach

CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
ABSTRACT Antibody–drug conjugates (ADCs) are a promising class of targeted cancer therapies. However, they need careful dose optimization to maximize effectiveness and minimize side effects. Sometimes, safety issues may only become apparent after approval, so ongoing evaluation is important.
Innocent Gerald Asiimwe, Nour Chtiba, Samer Mouksassi, Goonaseelan (Colin) Pillai, Raimund M. Peter, Eunice Yuen, Venkatesh Pilla Reddy   +6 more
wiley   +1 more source

Liver dysfunction in patients with IBD under immunosuppressive treatment: do we need to fear? [PDF]

, 2010
International ...
Beaugerie, Laurent, Gerbes, Alexander L.
core   +3 more sources

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

Postmarketing surveillance of the oxidative stability for cooking oils, frying oils, and vanaspati supplied in the retail market

Food Science & Nutrition, 2019
In this study, postmarketing surveillance (PMS) was conducted in terms of the parameters which are reliable indicators of the oxidative stability of cooking oils, frying oils, and vanaspati samples.
H. Tavakoli, M. Naderi, S. Jafari, M. H. Naeli   +3 more
semanticscholar   +1 more source

Effectiveness and Safety of Guselkumab in Patients With Moderate‐to‐Severe Plaque Psoriasis in Real‐World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study

The Journal of Dermatology, EarlyView.
ABSTRACT Clinical trials have demonstrated the efficacy and safety of guselkumab in patients with moderate‐to‐severe plaque psoriasis. Real‐world evidence for guselkumab in Korea is needed to establish drug safety and effectiveness under real‐world practice in this population.
Bong Seok Shin, Miri Kim, Moo Kyu Suh, Young Bok Lee, Sang Woong Youn, Ji Yeoun Lee, Chul Woo Kim, Ga‐Young Lee, Sang Wook Son, Kwang Ho Kim, Jihye An, Youngdoe Kim, Kwang Joong Kim, Dong Hyun Kim   +13 more
wiley   +1 more source

Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet’s disease: a large-scale, long-term postmarketing surveillance in Japan

Arthritis Research & Therapy, 2019
BackgroundInfliximab, an anti-tumor necrosis factor-alpha antibody, has been reported to have excellent efficacy for refractory uveoretinitis in Behçet’s disease (RUBD), and was approved for this indication in Japan. However, the long-term safety profile
S. Ohno, I. Umebayashi, Miyuki Matsukawa, T. Goto, T. Yano   +4 more
semanticscholar   +1 more source