Results 241 to 250 of about 110,474 (301)

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh   +5 more
wiley   +1 more source

Quantitative prediction of intravenous drug interactions caused by cytochromes P450 inhibitors and inducers

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Background Aims Pharmacokinetic interaction studies typically focus on oral administration, but intravenous (IV) administration bypasses intestinal degradation and hepatic first‐pass metabolism, leading to distinct drug–drug interaction (DDI) magnitude. This study aimed to develop a predictive model for DDIs involving IV‐administered drugs.
Vianney Tuloup   +2 more
wiley   +1 more source

Label-free optical observation of disordered-to-ordered transitions in single intrinsically disordered proteins. [PDF]

open access: yesNPJ Biosens
Zargarbashi S   +12 more
europepmc   +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

Selected Proteins Involved in the Neuropathology of ASD as the Candidates for Fluid Biomarkers. [PDF]

open access: yesMolecules
Rutkowski P   +4 more
europepmc   +1 more source

First‐in‐human, phase I, randomized, safety, pharmacokinetic, food‐effect and pharmacodynamic study of a tyrosine kinase 2/Janus kinase 1 inhibitor, SDC‐1801

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), food‐effect (FE) and pharmacodynamics (PD) of an oral tyrosine kinase‐2 (TYK2)/Janus kinase‐1 (JAK1) inhibitor, SDC‐1801, in healthy adult participants. Methods This first‐in‐human study randomized 95 male and female participants.
Chris Brearley   +3 more
wiley   +1 more source

Prediction of Human Serum Concentration–Time Profiles of Golimumab and Ustekinumab Using Pharmacokinetic Data From Common Marmosets With Assessment of Anti‐Drug Antibodies

open access: yesBiopharmaceutics &Drug Disposition, EarlyView.
This study identified new optimal allometric scaling exponents for human PK prediction of monoclonal antibodies with linear PKs from marmoset PK data. In addition, immunogenicity in common marmosets was evaluated following the repeated dose of golimumab and ustekinumab, minimal anti‐drug antibodies were detected.
Ayaka Tajiri   +6 more
wiley   +1 more source

Multi‐Scale Hybrid Modeling to Predict Cell Culture Process With Metabolic Phase Transitions

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT To advance understanding of cellular metabolism and reduce batch‐to‐batch variability in cell culture processes, this study introduces a multi‐scale hybrid modeling framework designed to simulate and predict the dynamic behavior of CHO cell cultures undergoing metabolic phase transitions.
Keqi Wang, Sarah W. Harcum, Wei Xie
wiley   +1 more source

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