Results 141 to 150 of about 135,512 (307)

Políticas educativas, trabajo docente y extractivismo. Situaciones de disputa en la Norpatagonia a inicios del siglo XXI [PDF]

El presente proyecto surge a partir del interés por comprender las situaciones de disputa que se manifiestan en las políticas educativas y en el trabajo docente en particular, a partir del impacto generado por las prácticas “extractivistas” en el ...
Penas, Ema Paula, Laurente, María Jose
core  

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

British Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher, Amina Džidić‐Krivić, Emma Pinjic, Nejra Selak, Kanita Omerbasic, Alexandar Chupin, Andrej Belancic, Almir Fajkic   +7 more
wiley   +1 more source

EMA sensor placement.

, 2018
EMA sensor placement.
Samantha Gordon Danner (5608535), Sungbok Lee (5608541), Benjamin Parrell (5608538), Louis Goldstein (617215), Yoonjeong Lee (4379731), Dani Byrd (5608544)   +5 more
core   +1 more source

KEY TRENDS ANALYSIS OF RESULTS OBTAINED FROM INSPECTING THE FOREIGN MANUFACTURERS OF MEDICINAL PRODUCTS IN 2016

Разработка и регистрация лекарственных средств, 2019
The matter presents a statistical evaluation of results obtained from GMP inspections of foreign pharmaceutical manufacturers held by Russian GMP-inspectorate in the year 2016.
V. A. Orlov
doaj  

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS

Разработка и регистрация лекарственных средств, 2019
During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ...
O. S. Kobyakova, E. S. Kulikov, I. A. Deev, A. A. Dmitriev, N. A. Tabakaev, I. D. Pimenov, D. S. Tyufilin   +6 more
doaj  

EMA – Publication of the EMA’s 2024 annual report

EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU). The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures.
openaire   +2 more sources

Comparative efficacy of GLP‐1 RA, tirzepatide and SGLT‐2 inhibitors in metabolic liver disease: A network meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aim Metabolic liver disease, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, is a major cause of chronic liver dysfunction worldwide, creating an urgent need for effective treatments. This systematic literature review (SLR) and network meta‐analysis (NMA) systematically reviews and compares the efficacy and safety ...
Andrej Belančić, Christina Antza, Anastasios Poutachidis, Smaro Palaska, Elvira Meni Maria Gkrinia, Andrea Katrin Faour, Yusuf Ziya Sener, Seher Sener, Rehena Sultana   +8 more
wiley   +1 more source

Increasing the reporting of adverse drug reaction‐related hospitalizations using an ICD‐10‐based identification workflow: A multicentre study from Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Background Reporting adverse drug reactions (ADRs) is essential for drug safety. In Switzerland, healthcare professionals are legally required to report serious and unlabelled ADRs, yet under‐reporting remains widespread. We tested a novel method to increase reporting of ADR‐related hospitalizations.
Georgia Anita Weber, Sophie‐Charlotte Bartel, Michael Boch, Christoph Rosen, Michael Bodmer, Balthasar Luzius Hug, Thomas Stammschulte, Patrick E. Beeler   +7 more
wiley   +1 more source