Results 151 to 160 of about 297,679 (294)

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert   +6 more
wiley   +1 more source

Repeated intradermal lipopolysaccharide challenge responses in healthy volunteers: Implications for clinical pharmacology studies

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Intradermal application of lipopolysaccharide (LPS), a Toll‐like receptor 4 agonist, induces a local inflammatory response and is used as a human challenge model to evaluate the pharmacodynamics of investigational medicinal products. While currently applied in a single, parallel‐group setting, alternative within‐subject designs involving repeated ...
Alexandra A. J. Sillé   +12 more
wiley   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan   +11 more
wiley   +1 more source

Supratherapeutic drug concentration triggers: A novel data‐driven approach to assess their value for medication safety surveillance in intensive care

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Electronic triggers (e‐triggers) are used as screening signals to detect potential adverse drug events (ADEs) and offer an effective system level approach for medication safety surveillance. Their clinical utility is typically evaluated through time‐consuming manual chart review by experts, limiting implementation.
Anne Paulien Langermans   +40 more
wiley   +1 more source

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