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Pharmacodynamic evaluation of zoliflodacin treatment of Neisseria gonorrhoeae strains with amino acid substitutions in the zoliflodacin target GyrB using a dynamic Hollow Fiber Infection Model

ABSTRACT: Pharmacodynamic evaluation of zoliflodacin in Neisseria gonorrhoeae using Hollow Fibre

PROVIDER: PRJEB50904 | ENA |

REPOSITORIES: ENA

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			Action	DRS
	ERR8961040_1.fastq.gz	Fastqsanger.gz
	ERR8961040_2.fastq.gz	Fastqsanger.gz
	ERR8961042_1.fastq.gz	Fastqsanger.gz
	ERR8961042_2.fastq.gz	Fastqsanger.gz

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Evaluation of zoliflodacin against Neisseria gonorrhoeae using Hollow Fibre Infection Model

Project description:Pharmacodynamic evaluation of dosing, bacterial kill and resistance suppression for zoliflodacin against Neisseria gonorrhoeae in a dynamic Hollow Fibre Infection Model (HFIM)

| PRJEB44416 | ENA

Pharmacodynamic evaluation of lefamulin in the treatment of gonorrhea using a Hollow Fiber Infection Model simulating Neisseria gonorrhoeae infections

Project description:Pharmacodynamic evaluation of lefamulin in the treatment of gonorrhea

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Hollow-Fiber Methodology for Pharmacokinetic/Pharmacodynamic Studies of Antimalarial Compounds.

Project description:Knowledge of pharmacokinetic/pharmacodynamic (PK/PD) relationships can enhance the speed and economy of drug development by enabling informed and rational decisions at every step, from lead selection to clinical dosing. For anti-infective agents in particular, dynamic in vitro hollow-fiber cartridge experiments permit exquisite control of kinetic parameters and the study of their consequent impact on pharmacodynamic efficacy. Such information is of great interest for the cost-restricted but much-needed development of new antimalarial drugs, especially since the major human pathogen Plasmodium falciparum can be cultivated in vitro but is not readily available in animal models. This protocol describes the materials and procedures for determining the PK/PD relationships of antimalarial compounds.

| S-EPMC4811375 | biostudies-literature

Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow fiber infection model

Project description:Pharmacodynamics of zoliflodacin and doxycycline in gonorrhea treatment

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Exploring the Pharmacokinetic/Pharmacodynamic Relationship of Relebactam (MK-7655) in Combination with Imipenem in a Hollow-Fiber Infection Model.

Project description:Resistance to antibiotics among bacterial pathogens is rapidly spreading, and therapeutic options against multidrug-resistant bacteria are limited. There is an urgent need for new drugs, especially those that can circumvent the broad array of resistance pathways that bacteria have evolved. In this study, we assessed the pharmacokinetic/pharmacodynamic relationship of the novel ?-lactamase inhibitor relebactam (REL; MK-7655) in a hollow-fiber infection model. REL is intended for use with the carbapenem ?-lactam antibiotic imipenem for the treatment of Gram-negative bacterial infections. In this study, we used an in vitro hollow-fiber infection model to confirm the efficacy of human exposures associated with the phase 2 doses (imipenem at 500 mg plus REL at 125 or 250 mg administered intravenously every 6 h as a 30-min infusion) against imipenem-resistant strains of Pseudomonas aeruginosa and Klebsiella pneumoniae Dose fractionation experiments confirmed that the pharmacokinetic parameter that best correlated with REL activity is the area under the concentration-time curve, consistent with findings in a murine pharmacokinetic/pharmacodynamic model. Determination of the pharmacokinetic/pharmacodynamic relationship between ?-lactam antibiotics and ?-lactamase inhibitors is complex, as there is an interdependence between their respective exposure-response relationships. Here, we show that this interdependence could be captured by treating the MIC of imipenem as dynamic: it changes with time, and this change is directly related to REL levels. For the strains tested, the percentage of the dosing interval time that the concentration remains above the dynamic MIC for imipenem was maintained at the carbapenem target of 30 to 40%, required for maximum efficacy, for imipenem at 500 mg plus REL at 250 mg.

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Targeted mass spectrometry enables quantification of novel pharmacodynamic biomarkers of ATM kinase inhibitors

Project description:ATM is a serine/threonine protein kinase that is responsible for initiation of DNA repair of double-stranded breaks and is a therapeutic target in cancer. A lack of analytically robust and multiplexed assays has hampered mechanistic studies of action and determination of optimal, robust pharmacodynamic biomarkers for clinical development of new therapies targeting ATM. Targeted mass spectrometry-based assays have been shown to be capable of enabling quantitative phosphosignaling studies and identification of novel phosphorylation sites. To identify new pharmacodynamic markers of ATM inhibition and expand the capabilities of targeted proteomics for quantitative profiling of the DNA damage response, we developed and fully analytically characterized a 51-plex assay quantifying protein expression and post-translational modification (phosphorylation) following induction of DNA damage. The linear range was over 3 orders of magnitude, the median inter-assay variability was 11% CV, and the assay is capable of being used in conjunction with other multiple reaction monitoring-based multiplexed assay panels. Proof-of-principle studies quantify signaling following DNA damage (ionizing radiation) in immortalized cell lines and primary human cells, identifying NUMA1 pS395 as a PD marker for ATM inhibition following DNA damage. Furthermore, the study shows the utility of using a quantitative multiplexed assay for studying cellular signaling dynamics, and the potential application to pharmacodynamic and mechanism of action studies, including development of new pharmacodynamic markers for clinical application.

2021-07-29 | PXD026103 | Pride

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2008-10-20 | E-GEOD-9666 | biostudies-arrayexpress

Pharmacodynamic Biomarkers and Differential Effects of TNF- and GM-CSF-Targeting Biologics in Rheumatoid Arthritis

Project description:A major unmet need in rheumatoid arthritis (RA) is the choice of treatment options for patients with an inadequate response to anti-TNF agents (anti-TNF–IR). In order to identify pharmacodynamic biomarkers and assess differential effects of TNF- and non–TNF-targeting agents on RA patients with an inadequate response to anti-TNF–IR in comparison with biologic-naïve patients, peripheral protein markers and gene expression levels in association with clinical response posttreatment in two disease strata were assessed in disease-modifying antirheumatic drug (DMARD)-IR and anti-TNF-IR patients. Serum proteomics results indicated the existence of specific pharmacodynamic markers for golimumab and mavrilimumab, regardless of prior anti-TNF treatment. In contrast, both antibodies induced early and sustained suppression of RA disease markers, including IL-6, CRP, IL2RA, and MMP1, in DMARD-IR patients. Golimumab-induced early changes rapidly returned toward baseline concentrations in anti-TNF–IR patients, whereas mavrilimumab-induced changes were maintained through Day 169. RNA sequencing demonstrated gene expression changes at Day 169 after administration of mavrilimumab but not golimumab in anti-TNF–IR patients. Additionally, receiver operating characteristic curve and regression analysis showed the association of early IL-6 change and subsequent clinical responses to golimumab in anti-TNF-IR patients. Our results revealed golimumab- and mavrilimumab-specific pharmacodynamic biomarkers, and demonstrated differential biomarker-treatment relationships in anti-TNF–IR and DMARD-IR patients respectively. Early IL-6 change after anti-TNF antibody treatment may be a potential predictive biomarker for selection of different treatment regimens in anti-TNF-IR patients.

2019-06-13 | GSE120178 | GEO

The Effects of PEI Hollow Fiber Substrate Characteristics on PDMS/PEI Hollow Fiber Membranes for CO2/N2 Separation.

Project description:The CO2 separation from flue gas based on membrane technology has drawn great attention in the last few decades. In this work, polyetherimide (PEI) hollow fibers were fabricated by using a dry-jet-wet spinning technique. Subsequently, the composite hollow fiber membranes were prepared by dip coating of polydimethylsiloxane (PDMS) selective layer on the outer surface of PEI hollow fibers. The hollow fibers spun from various spinning conditions were fully characterized. The influence of hollow fiber substrates on the CO2/N2 separation performance of PDMS/PEI composite membranes was estimated by gas permeance and ideal selectivity. The prepared composite membrane where the hollow fiber substrate was spun from 20 wt% of dope solution, 12 mL/min of bore fluid (water) flow rate exhibited the highest ideal selectivity equal to 21.3 with CO2 permeance of 59 GPU. It was found that the dope concentration, bore fluid flow rate and bore fluid composition affect the porous structure, surface morphology and dimension of hollow fibers. The bore fluid composition significantly influenced the gas permeance and ideal selectivity of the PDMS/PEI composite membrane. The prepared PDMS/PEI composite membranes possess comparable CO2/N2 separation performance to literature ones.

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