Results 101 to 110 of about 20,311 (259)

Navigating adverse immunostimulation: A practical guide for clinical researchers

British Journal of Clinical Pharmacology, EarlyView.
Problem Setting As drug development moves towards more complex products, early clinical development programmes are increasingly hampered by unwanted and/or unexpected activation of the immune system (adverse immune stimulation, AIS). Solution At the Centre for Human Drug Research, we have introduced standardized procedures to make AIS manageable, while
Juliette A. van den Noort, Anouk C. Meijs, Naomi B. Klarenbeek, Matthijs Moerland   +3 more
wiley   +1 more source

Umelá inteligencia a správne uváženie

Acta Universitatis Carolinae Iuridica
Artificial intelligence is becoming a part of everyday life. The more it applies, the more it finds itself in the activities of the state. The state seeks to exploit the potential of artificial intelligence and with its help to simplify, streamline, and ...
Radomír Jakab
doaj   +1 more source

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

A dose‐finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti‐gremlin‐1 monoclonal antibody, in patients with solid tumours

British Journal of Clinical Pharmacology, EarlyView.
Aims Ginisortamab, a first‐in‐class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin‐1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin‐1 binding, using model‐based simulations ...
Yin Cheong Wong, Luisa Rojas Chavarro, Paul Jones, David Egging, Wanchana Ungphakorn, Marta Valle, Ivan Matthews   +6 more
wiley   +1 more source

¿«Avasalla» la Sala 3.ª del Tribunal Supremo al Consejo General del Poder Judicial? (De nuevo sobre el control judicial de la discrecionalidad)

Revista Vasca de Administración Pública, 2016
This article focuses on analyzing an individual opinion to a Supreme Court¿s ruling that annulled a discretional appointment to the General Council of the Judiciary.
Juan Igartua Salaverría
doaj   +1 more source

Infusion rate adjustment in enzyme replacement therapy with pabinafusp alfa for mucopolysaccharidosis II

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Enzyme replacement therapy (ERT) for mucopolysaccharidosis II (MPS II) requires long‐term, weekly intravenous infusions often lasting over 3 h each time, which can burden paediatric patients and caregivers and negatively affect their quality of life and treatment compliance.
Kimitoshi Nakamura, Norio Sakai, Hideaki Hirai, Naoko Takasao, Ryo Ibaraki, Tatsuyoshi Yamamoto, Yuji Sato   +6 more
wiley   +1 more source

Unintended consequences of fighting corruption: judicial decisions for the award of public contracts in three Italian cities

Italian Political Science, 2019
By building on Spiller (2008) and Moszoro and Spiller (2012), this paper analyses the implementation of the Italian Code of Public Contracts. Contracting authorities are expected to design tendering procedures strategically, using less discretion the ...
Elisa Rebessi
doaj  

Identification of antibiotic allergies in children using prescribing patterns in the electronic medical record

British Journal of Clinical Pharmacology, EarlyView.
Background By age three, 5%–75% of children have a documented antibiotic allergy (AL). Despite this prevalence, recognition remains low because of limited clinician knowledge and time. Our study evaluates a novel approach to identifying AL using electronic medical record (EMR) prescription patterns.
Georgia Koutsaplis, Kailey Tang, Renee Dimond, Alice Lei, Amanda Wilkins, Amanda Gwee   +5 more
wiley   +1 more source

Oseltamivir drug‐disease modelling in infants with influenza virus infection

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Oseltamivir is a commonly used neuraminidase inhibitor for treatment of influenza infection, but little data exist regarding concentration‐response relationships. Methods Pharmacokinetic (PK) and viral dynamic data from an earlier NIAID Collaborative Antiviral Study Group trial in paediatric patients with influenza from 0–23 months of age
Kun Wang, David W. Kimberlin, Richard J. Whitley, Edward P. Acosta, For the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group   +4 more
wiley   +1 more source

S. aureus colonization and clinical symptoms remain stable upon topical XZ.700 treatment: Results of a double‐blind randomized clinical trial in patients with mild to moderate atopic dermatitis

British Journal of Clinical Pharmacology, EarlyView.
Aim Recovering dysbiosis may improve atopic dermatitis (AD) symptoms. XZ.700 is a recombinant chimeric endolysin that specifically targets Staphylococcus aureus and could be a new treatment option for patients with AD. The aim of this first‐in‐human study was to evaluate the safety, tolerability and efficacy of topical XZ.700 and explore the ...
Laura W. J. van der Meulen, Menthe E. Bergmans, Salma Assil, Naomi Klarenbeek, Marieke L. de Kam, Alexa J. Tibboel, Thorsten Brach, Bjorn L. Herpers, Johan Frieling, Vincent de Jong, Benthe Freyee, Martijn B. A. van Doorn, Robert Rissmann, Tessa Niemeyer–van der Kolk   +13 more
wiley   +1 more source