Results 181 to 190 of about 2,876,536 (275)

Navigating adverse immunostimulation: A practical guide for clinical researchers

open access: yesBritish 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   +3 more
wiley   +1 more source

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

open access: yesBritish 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   +8 more
wiley   +1 more source

Population pharmacokinetics of levofloxacin in breastmilk in patients with rifampicin‐resistant tuberculosis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Levofloxacin is a widely used antibiotic included in rifampicin‐resistant tuberculosis (RR‐TB) treatment. Data describing levofloxacin concentrations in breastmilk and infant exposure are limited. We analysed data from two South African studies of breastfeeding women receiving levofloxacin (750–1000 mg daily) for RR‐TB.
Sharon Sawe   +9 more
wiley   +1 more source

Genomic analysis of Canadian children with food allergies points to the immunoglobulin heavy chain gene locus. [PDF]

open access: yesPediatr Allergy Immunol
Madore AM   +11 more
europepmc   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar   +6 more
wiley   +1 more source

Exploratory analyses of predictors and correlates of response to omalizumab therapy in patients with multiple food allergies. [PDF]

open access: yesJ Allergy Clin Immunol
Chinthrajah RS   +33 more
europepmc   +1 more source

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl   +14 more
wiley   +1 more source

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