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PMC8843667
core_pubmed_pmc
Alpelisib-Induced Diabetes Mellitus: Case Report, Pharmacodynamics and Management Considerations
Alpelisib-Induced Diabetes Mellitus: Case Report, Pharmacodynamics and Management Considerations Abstract Introduction Alpelisib is an orally selective PI3K alpha inhibitor recently available for the treatment of advanced breast cancer. PI3K pathway is an intracellular signaling pathway that plays an important role in ...
PMC11125931
core_pubmed_pmc
Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV
Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV Abstract Abstract Monoclonal antibodies are commonly engineered with an introduction of Met428Leu and Asn434Ser, known as the LS mutation, in the ...
PMC5437664
core_pubmed_pmc
Inhibition of O-GlcNAcase leads to elevation of O-GlcNAc tau and reduction of tauopathy and cerebrospinal fluid tau in rTg4510 mice
Inhibition of O-GlcNAcase leads to elevation of O-GlcNAc tau and reduction of tauopathy and cerebrospinal fluid tau in rTg4510 mice Abstract Abstract Background Hyperphosphorylation of microtubule-associated protein tau is a distinct feature of neurofibrillary tangles (NFTs) that are the hallmark of neurodegenerative t...
PMC11163076
core_pubmed_pmc
Establishing adherence–concentration–efficacy thresholds of TDF–FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF–FTC Benchmark Study
Establishing adherence–concentration–efficacy thresholds of TDF–FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF–FTC Benchmark Study Abstract Background Oral pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a...
PMC11418394
core_pubmed_pmc
Chemotherapy for the treatment of alveolar echinococcosis: Where are we?
Chemotherapy for the treatment of alveolar echinococcosis: Where are we? Abstract Abstract Alveolar echinococcosis (AE) is a severe liver disease due to infection with the Echinococcus multilocularis larval stage, called the metacestode. Management of AE is based on benzimidazole chemotherapy (albendazole or mebendazol...
PMC5971609
core_pubmed_pmc
Pharmacokinetics and Pharmacodynamics of Fosfomycin and Its Activity against Extended-Spectrum-β-Lactamase-, Plasmid-Mediated AmpC-, and Carbapenemase-Producing Escherichia coli in a Murine Urinary Tract Infection Model
Pharmacokinetics and Pharmacodynamics of Fosfomycin and Its Activity against Extended-Spectrum-β-Lactamase-, Plasmid-Mediated AmpC-, and Carbapenemase-Producing Escherichia coli in a Murine Urinary Tract Infection Model Abstract ABSTRACT Fosfomycin has become an attractive treatment alternative for urinary tract infect...
PMC10659066
core_pubmed_pmc
Pharmacokinetic and pharmacodynamic considerations for antifungal therapy optimisation in the treatment of intra-abdominal candidiasis
Pharmacokinetic and pharmacodynamic considerations for antifungal therapy optimisation in the treatment of intra-abdominal candidiasis Abstract Abstract Intra-abdominal candidiasis (IAC) is one of the most common of invasive candidiasis observed in critically ill patients. It is associated with high mortality, with up ...
PMC9367699
core_pubmed_pmc
PET imaging to assess fibroblast activation protein inhibitor biodistribution: A training program adapted to pharmacology education
PET imaging to assess fibroblast activation protein inhibitor biodistribution: A training program adapted to pharmacology education Abstract Abstract In the process of pharmacology education, practical teaching is an important complement to theoretical teaching. These activities include the use of experimental animals ...
PMC12081902
core_pubmed_pmc
First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors
First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors Abstract Background EMB-02 is a symmetric bispecific antibody targeting programmed cell death protein-1 and lymphocyte-activation gene 3 simultaneously. Here, we present the first-in-human study...
PMC6899639
core_pubmed_pmc
Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti‐ CD 20 monoclonal antibody for the desensitization of candidates for renal transplant
Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti‐ CD 20 monoclonal antibody for the desensitization of candidates for renal transplant Abstract The limited effectiveness of rituximab plus intravenous immunoglobulin ( IVIG ) in desensitization may be due to incomplete B cell depletio...
PMC4301837
core_pubmed_pmc
Aldosterone synthase inhibition: cardiorenal protection in animal disease models and translation of hormonal effects to human subjects
Aldosterone synthase inhibition: cardiorenal protection in animal disease models and translation of hormonal effects to human subjects Abstract Background Aldosterone synthase inhibition provides the potential to attenuate both the mineralocorticoid receptor-dependent and independent actions of aldosterone. In vitro st...
PMC6989246
core_pubmed_pmc
PKconverter: R package to convert the pharmacokinetic parameters
PKconverter: R package to convert the pharmacokinetic parameters Abstract Abstract Population pharmacokinetic analysis and modeling procedures typically require estimates of both population and individual pharmacokinetic parameters. However, only some of these parameters are contained in models and only parameters in t...
PMC7721091
core_pubmed_pmc
HM30181A, a potent P-glycoprotein inhibitor, potentiates the absorption and in vivo antitumor efficacy of paclitaxel in an orthotopic brain tumor model
HM30181A, a potent P-glycoprotein inhibitor, potentiates the absorption and in vivo antitumor efficacy of paclitaxel in an orthotopic brain tumor model Abstract Abstract Objective: Delivery of chemotherapeutic drugs to the brain has remained a major obstacle in the treatment of glioma, owing to the presence of the bloo...
PMC4569680
core_pubmed_pmc
Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus
Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus Abstract Introduction Canagliflozin is a sodium glucose co-transporter 2 inhibitor approved worldwide for the treatment of patients with type 2 diabetes mellitus (T2DM). The present study evaluated pharmac...
PMC5681758
core_pubmed_pmc
Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se)
Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se) Abstract Abstract Background Severe sepsis and septic shock remain a major challenge, even in modern intensive ca...
PMC9314306
core_pubmed_pmc
Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients
Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients Abstract Abstract Purpose The current study aimed to illustrate how a non-linear mixed effect (NLME) model-based analysis may improve confiden...
PMC12571850
core_pubmed_pmc
BYS10, a novel selective RET inhibitor, exhibits potent antitumor activity in preclinical models
BYS10, a novel selective RET inhibitor, exhibits potent antitumor activity in preclinical models Abstract Abstract Background Aberrant alterations in the RET gene serve as oncogenic drivers in multiple cancers, making RET kinase inhibition a promising therapeutic strategy. However, acquired resistance limits the clinic...
PMC8674005
core_pubmed_pmc
Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer
Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer Abstract Abstract Liposomal irinotecan is a liposomal formulation of irinotecan, which prolongs circulation of irinotecan and its active metabolite SN‐38. A population p...
PMC9992749
core_pubmed_pmc
Development of thermosensitive hydrogel of Amphotericin-B and Lactoferrin combination-loaded PLGA-PEG-PEI nanoparticles for potential eradication of ocular fungal infections: In-vitro , ex-vivo and in-vivo studies
Development of thermosensitive hydrogel of Amphotericin-B and Lactoferrin combination-loaded PLGA-PEG-PEI nanoparticles for potential eradication of ocular fungal infections: In-vitro , ex-vivo and in-vivo studies Abstract Abstract The most prevalent conditions among ocular surgery and COVID−19 patients are fungal eye ...
PMC3139194
core_pubmed_pmc
Molecular Imaging and Pharmacokinetic Analysis of Carbon-11 Labeled Antisense Oligonucleotide LY2181308 in Cancer Patients
Molecular Imaging and Pharmacokinetic Analysis of Carbon-11 Labeled Antisense Oligonucleotide LY2181308 in Cancer Patients Abstract Antisense oligonucleotides (ASOs) have potential as anti-cancer agents by specifically modulating genes involved in tumorigenesis. However, little is known about ASO biodistribution and ti...
PMC12035594
core_pubmed_pmc
Killing several birds with one stone: A multi‐indication population pharmacokinetic model and Bayesian estimator for enteric‐coated mycophenolate sodium
Killing several birds with one stone: A multi‐indication population pharmacokinetic model and Bayesian estimator for enteric‐coated mycophenolate sodium Abstract Abstract Aims Mycophenolic acid (MPA), the active component of enteric‐coated mycophenolate sodium (EC‐MPS), exhibits highly variable pharmacokinetics. Only a...
PMC12065018
core_pubmed_pmc
ABCB1, SLC22A1, COMT, and OPRM1 genotypes: Study of their influence on plasma methadone levels and clinical response to methadone maintenance treatment in opioid use disorder
ABCB1, SLC22A1, COMT, and OPRM1 genotypes: Study of their influence on plasma methadone levels and clinical response to methadone maintenance treatment in opioid use disorder Abstract Abstract Background Opioid use disorder (OUD) is an emerging and global public health concern, and its management remains inadequate, no...
PMC2869454
core_pubmed_pmc
Factors affecting the long-term response to tacrolimus in renal transplant patients: Pharmacokinetic and pharmacogenetic approach
Factors affecting the long-term response to tacrolimus in renal transplant patients: Pharmacokinetic and pharmacogenetic approach Abstract Background: The aim of our study was to determine the impact of CYP3A5*1 and CYP3A5*3 on the kinetics of tacrolimus in renal transplant recipients. Material and methods: Forty kidne...
PMC11282505
core_pubmed_pmc
Treatment of a resistant case of schizoaffective disorder with lumateperone: A case report
Treatment of a resistant case of schizoaffective disorder with lumateperone: A case report Abstract To this day, there exists skepticism about the reliability and clinical utility of the diagnostic criteria and classification of schizoaffective disorder. In addition, the treatment of schizoaffective disorder, especiall...
PMC11725105
core_pubmed_pmc
Microneedles as transdermal drug delivery system for enhancing skin disease treatment
Microneedles as transdermal drug delivery system for enhancing skin disease treatment Abstract Abstract Microneedles (MNs) serve as a revolutionary paradigm in transdermal drug delivery, heralding a viable resolution to the formidable barriers presented by the cutaneous interface. This review examines MNs as an advance...
PMC5064724
core_pubmed_pmc
Evaluation of a Scenario in Which Estimates of Bioequivalence Are Biased and a Proposed Solution: t last (Common)
Evaluation of a Scenario in Which Estimates of Bioequivalence Are Biased and a Proposed Solution: t last (Common) Abstract Abstract In bioequivalence (BE) testing, it is the convention to identify t last separately for each concentration‐vs‐time profile. Within‐subject differences in t last between treatments can arise...
PMC12047412
core_pubmed_pmc
Plasma Trough Concentrations of Beta‐Lactam Antibiotics in the Early Phase of Septic Shock
Plasma Trough Concentrations of Beta‐Lactam Antibiotics in the Early Phase of Septic Shock Abstract ABSTRACT Introduction Septic shock necessitates timely antibiotic therapy, often with broad‐spectrum beta‐lactam antibiotics (ß‐LA). To our knowledge, no previous study has examined antibiotic concentrations repeatedly d...
PMC6541623
core_pubmed_pmc
Berberine alleviates hyperglycemia by targeting hepatic glucokinase in diabetic db/db mice
Berberine alleviates hyperglycemia by targeting hepatic glucokinase in diabetic db/db mice Abstract Abstract Berberine (BBR) is a widely used anti-diabetic agent, and liver glucokinase (GK) has been reported to be involved. However, the mechanisms of BBR in regulating GK are still unknown. Here, we found that BBR upreg...
PMC4467258
core_pubmed_pmc
The Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GSK1322322 in Healthy Volunteers
The Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GSK1322322 in Healthy Volunteers Abstract GSK1322322 is the first in a new class of antibiotics that inhibit peptide deformylase, necessary for bacterial protein maturation. Previously, low absolute bioavailability was observed for ...
PMC9952708
core_pubmed_pmc
Evaluation of Piperacillin/Sulbactam, Piperacillin/Tazobactam and Cefoperazone/Sulbactam Dosages in Gram-Negative Bacterial Bloodstream Infections by Monte Carlo Simulation
Evaluation of Piperacillin/Sulbactam, Piperacillin/Tazobactam and Cefoperazone/Sulbactam Dosages in Gram-Negative Bacterial Bloodstream Infections by Monte Carlo Simulation Abstract The optimal regimens of piperacillin/sulbactam (PIS 2:1), piperacillin/tazobactam (PTZ 8:1), and cefoperazone/sulbactam (CSL 2:1) are not ...
PMC12830235
core_pubmed_pmc
First‐in‐Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1617, a Cathepsin‐S Inhibitor, in Healthy Adult Subjects
First‐in‐Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1617, a Cathepsin‐S Inhibitor, in Healthy Adult Subjects Abstract ABSTRACT ASP1617 is a novel, highly selective inhibitor of cathepsin‐S, an important protease for antigen peptide loading onto major histocompatibilit...
PMC3414087
core_pubmed_pmc
Preparation and in vivo pharmacokinetics of curcumin-loaded PCL-PEG-PCL triblock copolymeric nanoparticles
Preparation and in vivo pharmacokinetics of curcumin-loaded PCL-PEG-PCL triblock copolymeric nanoparticles Abstract Abstract Background: Curcumin (CUR) has been linked with antioxidant, anti-inflammatory, antimicrobial, anti amyloid, and antitumor effects, but its application is limited because of its low aqueous solub...
PMC12401397
core_pubmed_pmc
Optimizing ketamine dosing strategies across diverse clinical applications: a comprehensive review
Optimizing ketamine dosing strategies across diverse clinical applications: a comprehensive review Abstract Abstract Ketamine has emerged as a versatile therapeutic agent with applications spanning anesthesia, pain management, and psychiatric disorders. This review examines ketamine’s clinical utility across diverse ad...
PMC4968108
core_pubmed_pmc
Quantitation and pharmacokinetic modeling of therapeutic antibody quality attributes in human studies
Quantitation and pharmacokinetic modeling of therapeutic antibody quality attributes in human studies Abstract ABSTRACT A thorough understanding of drug metabolism and disposition can aid in the assessment of efficacy and safety. However, analytical methods used in pharmacokinetics (PK) studies of protein therapeutics ...
PMC4716719
core_pubmed_pmc
Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)
Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment) Abstract Abstract Purpose Cariprazine is a potent dopamine D 3 -preferring D 3 /D 2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of caripr...
PMC8694396
core_pubmed_pmc
Impact of Maximizing Css/MIC Ratio on Efficacy of Continuous Infusion Meropenem Against Documented Gram-Negative Infections in Critically Ill Patients and Population Pharmacokinetic/Pharmacodynamic Analysis to Support Treatment Optimization
Impact of Maximizing Css/MIC Ratio on Efficacy of Continuous Infusion Meropenem Against Documented Gram-Negative Infections in Critically Ill Patients and Population Pharmacokinetic/Pharmacodynamic Analysis to Support Treatment Optimization Abstract Abstract Introduction: optimal treatment of Gram-negative infections i...
PMC4230996
core_pubmed_pmc
Radiosynthesis and Evaluation of an 18 F-Labeled Positron Emission Tomography (PET) Radioligand for Metabotropic Glutamate Receptor Subtype 4 (mGlu 4 )
Radiosynthesis and Evaluation of an 18 F-Labeled Positron Emission Tomography (PET) Radioligand for Metabotropic Glutamate Receptor Subtype 4 (mGlu 4 ) Abstract Four 4-phthalimide derivatives of N -(3-chlorophenyl)-2-picolinamide were synthesized as potential ligands for the PET imaging of mGlu 4 in the brain. Of these...
PMC8918679
core_pubmed_pmc
First experience of a hemophilia monitoring platform: florio HAEMO
First experience of a hemophilia monitoring platform: florio HAEMO Abstract Abstract Background florio HAEMO is a new hemophilia treatment monitoring application consisting of a patient smartphone application (app) and a web‐based dashboard for healthcare professionals, providing several novel features, including activ...
PMC6058520
core_pubmed_pmc
Modification of translationally controlled tumor protein-derived protein transduction domain for improved intranasal delivery of insulin
Modification of translationally controlled tumor protein-derived protein transduction domain for improved intranasal delivery of insulin Abstract Abstract Carrier peptides, termed protein transduction domains (PTDs), serve as provide promising vehicles for intranasal delivery of macromolecular drugs. A mutant PTD deriv...
PMC12699562
core_pubmed_pmc
Systemic STING agonist therapy drives expression of interferon stimulated genes and downstream production of cytokines in dogs with solid tumors
Systemic STING agonist therapy drives expression of interferon stimulated genes and downstream production of cytokines in dogs with solid tumors Abstract Abstract Background Stimulator of interferon genes (STING) agonist drugs can induce expression of interferon stimulated genes (ISGs) and proinflammatory cytokine prod...
PMC7322758
core_pubmed_pmc
Ultra-sensitive bioanalysis of the therapeutic peptide exenatide for accurate pharmacokinetic analyses at effective plasma concentrations utilizing UPLC-MS/MS
Ultra-sensitive bioanalysis of the therapeutic peptide exenatide for accurate pharmacokinetic analyses at effective plasma concentrations utilizing UPLC-MS/MS Abstract Exenatide is the first approved glucagon-like peptide 1 receptor agonist subcutaneously or intramuscularly injected for the treatment of type 2 diabetes...
PMC6722387
core_pubmed_pmc
Generation of Human iPSC–Derived Intestinal Epithelial Cell Monolayers by CDX2 Transduction
Generation of Human iPSC–Derived Intestinal Epithelial Cell Monolayers by CDX2 Transduction Abstract Abstract Background & aims To develop an effective and safe orally administered drug, it is important to predict its intestinal absorption rate, intestinal first-pass effect, and drug-drug interactions of orally adminis...
PMC9966583
core_pubmed_pmc
The Role of “Physiologically Based Pharmacokinetic Model (PBPK)” New Approach Methodology (NAM) in Pharmaceuticals and Environmental Chemical Risk Assessment
The Role of “Physiologically Based Pharmacokinetic Model (PBPK)” New Approach Methodology (NAM) in Pharmaceuticals and Environmental Chemical Risk Assessment Abstract Physiologically Based Pharmacokinetic (PBPK) models are mechanistic tools generally employed in the pharmaceutical industry and environmental health risk...
PMC4529213
core_pubmed_pmc
Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active α-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase
Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active α-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase Abstract Abstract Migalastat HCl (AT1001, 1-Deoxygalactonojirimycin) is an investigational pharmacological chaperone for the treatment of α-galactosidase A ...
PMC6657005
core_pubmed_pmc
A Comprehensive Framework for Physiologically‐Based Pharmacokinetic Modeling in Matlab
A Comprehensive Framework for Physiologically‐Based Pharmacokinetic Modeling in Matlab Abstract Physiologically‐based pharmacokinetic (PBPK) models are useful tools to predict clinical scenarios for special populations for whom there are high hurdles to conduct clinical trials such as children or the elderly. However, ...
PMC4712753
core_pubmed_pmc
Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis
Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis Abstract Objective: To assess usability, bioavailability, and safety of subcutaneous self-administration of 0.3 mL of methotrexate 50 mg/m...
PMC5944578
core_pubmed_pmc
Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF‐CC) in Subjects With Severe Hemophilia A
Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF‐CC) in Subjects With Severe Hemophilia A Abstract Abstract An open‐label, single‐dose, randomized, two‐period, crossover study comparing the pharmacokinetics of factor VIII activity in plasma (FVIII:C) after administration of an albumin‐f...
PMC10539503
core_pubmed_pmc
Reproducibility in pharmacometrics applied in a phase III trial of BCG-vaccination for COVID-19
Reproducibility in pharmacometrics applied in a phase III trial of BCG-vaccination for COVID-19 Abstract Large clinical trials often generate complex and large datasets which need to be presented frequently throughout the trial for interim analysis or to inform a data safety monitory board (DSMB). In addition, reliable...
PMC6114027
core_pubmed_pmc
A Controlled Release System for Long-Acting Intravitreal Delivery of Small Molecules
A Controlled Release System for Long-Acting Intravitreal Delivery of Small Molecules Abstract Purpose The short half lives of small molecules in the vitreous requires frequent repeated intravitreal injections that are impractical for treatment of chronic eye diseases. We sought to develop a method for increasing the in...
PMC12061369
core_pubmed_pmc
Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Voriconazole for Predicting the Clinical Outcomes of Adult Patients With Invasive Aspergillosis
Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Voriconazole for Predicting the Clinical Outcomes of Adult Patients With Invasive Aspergillosis Abstract Supplemental Digital Content is Available in the Text. Background: Voriconazole is the first-line therapy for invasive aspergillosis (IA). To determine the mi...
PMC2945360
core_pubmed_pmc
Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects
Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects Abstract Background Efforts to ease administration and enhance acceptability of the oral anti-malarial artemether-lumefantrine (A-L) crushed tablet to infants and children tri...
PMC8707067
core_pubmed_pmc
Predictors of Efavirenz Plasma Exposure, Auto-Induction Profile, and Effect of Pharmacogenetic Variations among HIV-Infected Children in Ethiopia: A Prospective Cohort Study
Predictors of Efavirenz Plasma Exposure, Auto-Induction Profile, and Effect of Pharmacogenetic Variations among HIV-Infected Children in Ethiopia: A Prospective Cohort Study Abstract Abstract (1) Background: Efavirenz plasma concentration displays wide between-patient variability partly due to pharmacogenetic variation...
PMC7153006
core_pubmed_pmc
Kaji-Ichigoside F1 and Rosamultin Protect Vascular Endothelial Cells against Hypoxia-Induced Apoptosis via the PI3K/AKT or ERK1/2 Signaling Pathway
Kaji-Ichigoside F1 and Rosamultin Protect Vascular Endothelial Cells against Hypoxia-Induced Apoptosis via the PI3K/AKT or ERK1/2 Signaling Pathway Abstract Abstract As a pair of differential isomers, Kaji-ichigoside F1 and Rosamultin are both pentacyclic triterpenoids isolated from the subterranean root of Potentilla ...
PMC11749192
core_pubmed_pmc
Clinical predictors of 3-month isoniazid rifapentine (3HP)-related adverse drug reactions (ADR) during tuberculosis preventive therapy (PAnDoRA-3HP study): an observational study protocol
Clinical predictors of 3-month isoniazid rifapentine (3HP)-related adverse drug reactions (ADR) during tuberculosis preventive therapy (PAnDoRA-3HP study): an observational study protocol Abstract Abstract Abstract Introduction Tuberculosis (TB) is the leading infectious cause of death globally. Despite WHO recommendat...
PMC12641639
core_pubmed_pmc
Virtual Biomarkers and Simplified Metrics in the Modeling of Breast Cancer Neoadjuvant Therapy: A Proof-of-Concept Case Study Based on Diagnostic Imaging
Virtual Biomarkers and Simplified Metrics in the Modeling of Breast Cancer Neoadjuvant Therapy: A Proof-of-Concept Case Study Based on Diagnostic Imaging Abstract Abstract Background: Neoadjuvant chemotherapy (NAC) is a standard preoperative intervention for early-stage breast cancer (BC). Dynamic contrast-enhanced mag...
PMC9463470
core_pubmed_pmc
Enzyme-linked immunosorbent assays for quantification of MMAE-conjugated ADCs and total antibodies in cynomolgus monkey sera
Enzyme-linked immunosorbent assays for quantification of MMAE-conjugated ADCs and total antibodies in cynomolgus monkey sera Abstract Abstract Antibody-drug conjugates (ADCs) are commonly heterogeneous and require extensive assessment of exposure-efficacy and exposure-safety relationships in preclinical and clinical st...
PMC11273741
core_pubmed_pmc
Development and ELISA Characterization of Antibodies against the Colistin, Vancomycin, Daptomycin, and Meropenem: A Therapeutic Drug Monitoring Approach
Development and ELISA Characterization of Antibodies against the Colistin, Vancomycin, Daptomycin, and Meropenem: A Therapeutic Drug Monitoring Approach Abstract More than 70% of bacteria are resistant to all or nearly all known antimicrobials, creating the need for the development of new types of antimicrobials or the...
PMC7926796
core_pubmed_pmc
Utilisation of Chick Embryo Chorioallantoic Membrane as a Model Platform for Imaging-Navigated Biomedical Research
Utilisation of Chick Embryo Chorioallantoic Membrane as a Model Platform for Imaging-Navigated Biomedical Research Abstract Abstract The fertilised chick egg and particularly its chorioallantoic membrane (CAM) have drawn continuing interest in biomedicine and bioengineering fields, especially for research on vascular s...
PMC4406960
core_pubmed_pmc
Mixed Effects Modeling Using Stochastic Differential Equations: Illustrated by Pharmacokinetic Data of Nicotinic Acid in Obese Zucker Rats
Mixed Effects Modeling Using Stochastic Differential Equations: Illustrated by Pharmacokinetic Data of Nicotinic Acid in Obese Zucker Rats Abstract Abstract Inclusion of stochastic differential equations in mixed effects models provides means to quantify and distinguish three sources of variability in data. In addition...
PMC6485087
core_pubmed_pmc
Association between vancomycin pharmacokinetic/pharmacodynamic parameters, patient characteristics, and mortality in patients with bacteremia caused by vancomycin-susceptible Enterococcus faecium : a single-center retrospective study
Association between vancomycin pharmacokinetic/pharmacodynamic parameters, patient characteristics, and mortality in patients with bacteremia caused by vancomycin-susceptible Enterococcus faecium : a single-center retrospective study Abstract Abstract Background Vancomycin is commonly used to treat Enterococcus faecium...
PMC9483622
core_pubmed_pmc
Citrus aurantium ‘Changshan-huyou’—An ethnopharmacological and phytochemical review
Citrus aurantium ‘Changshan-huyou’—An ethnopharmacological and phytochemical review Abstract Abstract Citrus fruits are composed of oil cells layer, white membrane layer, pulp and seeds. The cultivar Citrus aurantium ‘Changshan-huyou’ (CACH) is a hybridization of Citrus grandis Osbeck and C. sinensis Osbeck. It is a ru...
PMC12941221
core_pubmed_pmc
Association of PFAS, Metals, Phthalate and Organophosphate Metabolites with Depression Among U.S. Adults
Association of PFAS, Metals, Phthalate and Organophosphate Metabolites with Depression Among U.S. Adults Abstract Highlights Public health relevance—How does this work relate to a public health issue? Depression is a major public health concern, and this study evaluates whether exposure to common environmental chemical...
PMC6220789
core_pubmed_pmc
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study Abstract Abstract Duvelisib (IPI‐145) is an oral dual inhibitor of phosphoinositide‐3‐kinase (PI3K)‐δ and ‐γ in clinical development for the treatment of hematologic malignancies, including indolent ...
PMC9606564
core_pubmed_pmc
Can Faster Aspart Be Used to Optimize Glycemic Control With Insulin Pump Therapy? From Expectations to Lessons Learned After a Year of Use in the United States
Can Faster Aspart Be Used to Optimize Glycemic Control With Insulin Pump Therapy? From Expectations to Lessons Learned After a Year of Use in the United States Abstract Fast-acting insulin aspart (faster aspart) is an ultra-rapid-acting formulation of insulin aspart developed to more closely match the prandial endogeno...
PMC9968170
core_pubmed_pmc
Interplay of Breast Cancer Resistance Protein (Bcrp/Abcg2), Sex, and Fed State in Oral Pharmacokinetic Variability of Furosemide in Rats
Interplay of Breast Cancer Resistance Protein (Bcrp/Abcg2), Sex, and Fed State in Oral Pharmacokinetic Variability of Furosemide in Rats Abstract Poor and variable oral bioavailability of furosemide (FUR) presents critical challenges in pharmacotherapy. We investigated the interplay of breast cancer resistance protein ...
PMC9878197
core_pubmed_pmc
Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID‐19 intensive care unit patients
Population pharmacokinetics of nadroparin for thromboprophylaxis in COVID‐19 intensive care unit patients Abstract Aims Nadroparin is administered to COVID‐19 intensive care unit (ICU) patients as thromboprophylaxis. Despite existing population pharmacokinetic (PK) models for nadroparin in literature, the population PK...
PMC11357215
core_pubmed_pmc
Impact of Probiotics on the Glycemic Control of Pediatric and Adolescent Individuals with Type 1 Diabetes: A Systematic Review and Meta-Analysis
Impact of Probiotics on the Glycemic Control of Pediatric and Adolescent Individuals with Type 1 Diabetes: A Systematic Review and Meta-Analysis Abstract Abstract Aims: Human recombinant insulin is currently the only therapy for children and adolescents with type 1 diabetes (T1D), although not always efficient for the ...
PMC12858804
core_pubmed_pmc
Rational design of cisplatin and carboplatin complexes for enhanced anticancer efficacy based on DFT QTAIM and docking analyses
Rational design of cisplatin and carboplatin complexes for enhanced anticancer efficacy based on DFT QTAIM and docking analyses Abstract Abstract Cisplatin (CP) and carboplatin (CBP), two key platinum‑based anticancer drugs, face clinical limitations that prompt the search for new strategies to enhance efficacy and red...
PMC8212712
core_pubmed_pmc
Early Clinical Experience With AZD4831, A Novel Myeloperoxidase Inhibitor, Developed for Patients With Heart Failure With Preserved Ejection Fraction
Early Clinical Experience With AZD4831, A Novel Myeloperoxidase Inhibitor, Developed for Patients With Heart Failure With Preserved Ejection Fraction Abstract Abstract We evaluated safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics of AZD4831, a novel oral myeloperoxidase (MPO) inhibitor, in a randomize...
PMC6017899
core_pubmed_pmc
Quantitative Analysis of Four Catechins from Green Tea Extract in Human Plasma Using Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Pharmacokinetic Studies
Quantitative Analysis of Four Catechins from Green Tea Extract in Human Plasma Using Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Pharmacokinetic Studies Abstract Green tea is consumed as a beverage worldwide and has beneficial effects, such as a lower risk of cardiovascular disease and cancer. ...
PMC3790178
core_pubmed_pmc
The interaction between prognostic and pharmacodynamic biomarkers
The interaction between prognostic and pharmacodynamic biomarkers Abstract Abstract Background: Interactions between prognostic and pharmacodynamic (PD) biomarkers have received little attention. Methods: Prognostic and PD utilities were assessed with linear mixed-effects models using published data on repeated measure...
PMC10027063
core_pubmed_pmc
PhysiPKPD: A pharmacokinetics and pharmacodynamics module for PhysiCell
PhysiPKPD: A pharmacokinetics and pharmacodynamics module for PhysiCell Abstract Abstract Pharmacokinetics and pharmacodynamics (PKPD) are key considerations in any study of molecular therapies. It is thus imperative to factor their effects into any in silico model of biological tissue involving such therapies. Further...
PMC12633374
core_pubmed_pmc
In Silico Post-screening of Anti-polymerization Agents to Treat Sickle Cell Disease
In Silico Post-screening of Anti-polymerization Agents to Treat Sickle Cell Disease Abstract Sickle cell disease (SCD) is a genetic disorder that affects approximately 100,000 individuals in the United States and millions globally. Although curative therapies, such as stem cell transplant and gene therapy, are availabl...
PMC11304681
core_pubmed_pmc
Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults
Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults Abstract ABSTRACT Islatravir is a deoxynucleoside analog being developed for the treatment of HIV-1 infection. Clinical studies are being conducted to evaluate islatravir, administ...
PMC8648050
core_pubmed_pmc
Synthesis and structure-activity relationship study of new biaryl amide derivatives and their inhibitory effects against hepatitis C virus
Synthesis and structure-activity relationship study of new biaryl amide derivatives and their inhibitory effects against hepatitis C virus Abstract Abstract A series of novel biaryl amide derivatives were synthesized and evaluated for anti-HCV virus activity. Some significant SARs were uncovered. The intensive structur...
PMC11311774
core_pubmed_pmc
An Injury-like Signature of the Extracellular Glioma Metabolome
An Injury-like Signature of the Extracellular Glioma Metabolome Abstract Simple Summary In this study, we performed microdialysis in patient-derived xenografts of glioma, intending to evaluate the extracellular metabolic impacts of temozolomide, a component of standard-of-care treatment. Unexpectedly, the most striking...
PMC10406176
core_pubmed_pmc
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Novel Intravenous Formulation of Meloxicam (QP001) in Healthy Chinese Subjects
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Novel Intravenous Formulation of Meloxicam (QP001) in Healthy Chinese Subjects Abstract Background Meloxicam is a selective cyclooxygenase-2 inhibitor used for pain relief, but its poor solubility limits its clinical applications. QP001 is a ...
PMC7754455
core_pubmed_pmc
An Adaptive Physiologically Based Pharmacokinetic–Driven Design to Investigate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Molibresib (GSK525762) in Healthy Female Volunteers
An Adaptive Physiologically Based Pharmacokinetic–Driven Design to Investigate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Molibresib (GSK525762) in Healthy Female Volunteers Abstract Abstract Molibresib (GSK525762), an orally bioavailable small molecule with 2 major equipotent active metabolit...
PMC5890728
core_pubmed_pmc
Improved power for TB Phase IIa trials using a model-based pharmacokinetic–pharmacodynamic approach compared with commonly used analysis methods
Improved power for TB Phase IIa trials using a model-based pharmacokinetic–pharmacodynamic approach compared with commonly used analysis methods Abstract Abstract Background: The demand for new anti-TB drugs is high, but development programmes are long and costly. Consequently there is a need for new strategies capable...
PMC9426762
core_pubmed_pmc
Tralesinidase Alfa Enzyme Replacement Therapy Prevents Disease Manifestations in a Canine Model of Mucopolysaccharidosis Type IIIB
Tralesinidase Alfa Enzyme Replacement Therapy Prevents Disease Manifestations in a Canine Model of Mucopolysaccharidosis Type IIIB Abstract Mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome B; OMIM #252920) is a lethal, pediatric, neuropathic, autosomal recessive, and lysosomal storage disease with no appr...
PMC12146532
core_pubmed_pmc
First-in-human study of FAZ053, an anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody, alone and in combination with spartalizumab, in patients with advanced malignancies
First-in-human study of FAZ053, an anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody, alone and in combination with spartalizumab, in patients with advanced malignancies Abstract Abstract Background FAZ053 triggers an antitumor response by targeting programmed death-ligand 1 (PD-L1), thereby activating ef...
PMC9563210
core_pubmed_pmc
Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study
Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study Abstract Background Trastuzumab given intravenously in combination with chemotherapy is stan...
PMC8664889
core_pubmed_pmc
Dopamine dysfunction in stimulant-use disorders: Mechanistic comparisons and implications for treatment
Dopamine dysfunction in stimulant-use disorders: Mechanistic comparisons and implications for treatment Abstract Dopamine system deficiencies and associated behavioral phenotypes may be a critical barrier to success in treating stimulant use disorders. Similarities in dopamine dysfunction between cocaine and methamphet...
PMC6194777
core_pubmed_pmc
Rhenium-188 Hydroxyethane 1,1-Diphosphonic Acid (HEDP) for Bone Pain Palliation Using BARC-HEDP Kits versus Pars-HEDP Kits: A Comparison on Preparation and Performance Aspects at Hospital Radiopharmacy
Rhenium-188 Hydroxyethane 1,1-Diphosphonic Acid (HEDP) for Bone Pain Palliation Using BARC-HEDP Kits versus Pars-HEDP Kits: A Comparison on Preparation and Performance Aspects at Hospital Radiopharmacy Abstract Purpose of the Study: Rhenium-188 hydroxyethane 1,1-diphosphonic acid (HEDP) is a clinically established radi...
PMC12888459
core_pubmed_pmc
Interpretation of the efficacy-oriented components of decoction pieces in compounds based on the spectrum-effect relationship: Huangqin Qingfei decoction as an example
Interpretation of the efficacy-oriented components of decoction pieces in compounds based on the spectrum-effect relationship: Huangqin Qingfei decoction as an example Abstract Abstract Background Acute lung injury (ALI) is a severe respiratory inflammatory disorder with high morbidity and mortality. Huangqin Qingfei D...
PMC10811527
core_pubmed_pmc
PEGylated porcine–human recombinant uricase: A novel fusion protein with improved efficacy and safety for the treatment of hyperuricemia and renal complications
PEGylated porcine–human recombinant uricase: A novel fusion protein with improved efficacy and safety for the treatment of hyperuricemia and renal complications Abstract Abstract The growing prevalence of hyperuricemia necessitates the urgent development of more potent treatments. This study aimed to develop, optimize,...
PMC5494186
core_pubmed_pmc
Oral contraceptives cause evolutionarily novel increases in hormone exposure
Oral contraceptives cause evolutionarily novel increases in hormone exposure Abstract Abstract Background and objectives In the evolutionary past, women spent most of their reproductive lives either pregnant or in lactational amenorrhea, and rarely menstruated. The current pattern of frequent menses, and the associated...
PMC6875516
core_pubmed_pmc
Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab
Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab Abstract Abstract ABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cance...
PMC12807933
core_pubmed_pmc
A network meta-analysis of first-line treatment options for patients with Child-Pugh class B functional hepatocellular carcinoma: comparison of efficacy and safety
A network meta-analysis of first-line treatment options for patients with Child-Pugh class B functional hepatocellular carcinoma: comparison of efficacy and safety Abstract Introduction Management of patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh class B liver function is challenging owing to comp...
PMC5069304
core_pubmed_pmc
Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis
Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis Abstract Abstract Background and Objectives This analysis used a population pharmacokinetic approach to identify covariates that influence plasma exposure of liraglutide 3.0 mg, a glucagon-like peptide-1 (GLP-1) receptor agonist approved fo...
PMC10972361
core_pubmed_pmc
Metaphedrone (3-Methylmethcathinone): Pharmacological, Clinical, and Toxicological Profile
Metaphedrone (3-Methylmethcathinone): Pharmacological, Clinical, and Toxicological Profile Abstract Abstract Introduction: Synthetic cathinones are a group of novel psychoactive substances used as an alternative to classical recreational drugs. As a result of legal prohibitions on older generations of these compounds, ...
PMC11888825
core_pubmed_pmc
Dosing, Toxicity and Drug Concentrations for Ganciclovir/Valganciclovir in Preterm and Low Birthweight Infants Treated for Cytomegalovirus
Dosing, Toxicity and Drug Concentrations for Ganciclovir/Valganciclovir in Preterm and Low Birthweight Infants Treated for Cytomegalovirus Abstract Background: There is a lack of data regarding suitable dosage when administering intravenous ganciclovir (GCV) or oral valganciclovir (valGCV) to preterm and low birthweigh...
PMC9283351
core_pubmed_pmc
Applying pharmacokinetic/pharmacodynamic measurements for linezolid in critically ill patients: optimizing efficacy and reducing resistance occurrence
Applying pharmacokinetic/pharmacodynamic measurements for linezolid in critically ill patients: optimizing efficacy and reducing resistance occurrence Abstract Purpose Linezolid (LZD) levels are frequently insufficient in intensive care unit (ICU) patients receiving standard dose, which is predictive of a poor prognosi...
PMC6890583
core_pubmed_pmc
A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins
A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins Abstract The ability to predict subcutaneous (SC) absorption rate and tissue distribution of therapeutic proteins (TPs) using a bottom-up appr...
PMC3895279
core_pubmed_pmc
Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30–60 μm. Safety and Efficacy Study
Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30–60 μm. Safety and Efficacy Study Abstract Abstract Background This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug...
PMC6071545
core_pubmed_pmc
Optimal Regimens and Cutoff Evaluation of Tildipirosin Against Pasteurella multocida
Optimal Regimens and Cutoff Evaluation of Tildipirosin Against Pasteurella multocida Abstract Abstract Pasteurella multocida (PM) can invade the upper respiratory tract of the body and cause death and high morbidity. Tildipirosin, a new 16-membered-ring macrolide antimicrobial, has been recommended for the treatment of...
PMC9320266
core_pubmed_pmc
Systematic Comparison of Hospital-Wide Standard and Model-Based Therapeutic Drug Monitoring of Vancomycin in Adults
Systematic Comparison of Hospital-Wide Standard and Model-Based Therapeutic Drug Monitoring of Vancomycin in Adults Abstract Abstract We aimed to evaluate the predictive performance and predicted doses of a single-model approach or several multi-model approaches compared with the standard therapeutic drug monitoring (T...
PMC3171673
core_pubmed_pmc
Phase II study of sunitinib as second-line treatment for advanced gastric cancer
Phase II study of sunitinib as second-line treatment for advanced gastric cancer Abstract Summary Purpose. This phase II, open-label, multicenter study assessed the oral, multitargeted, tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received pri...
PMC11649425
core_pubmed_pmc
Global research trends in therapeutic drug monitoring of antimicrobials from 2000 to 2023: a bibliometric analysis
Global research trends in therapeutic drug monitoring of antimicrobials from 2000 to 2023: a bibliometric analysis Abstract Abstract Objective The practice of therapeutic drug monitoring (TDM) is widely used for maximizing the clinical efficacy of antimicrobials. However, a systematic bibliometric analysis providing an...
PMC11768776
core_pubmed_pmc
The Clinical Pharmacokinetics and Pharmacodynamics of Glimepiride—A Systematic Review and Meta-Analysis
The Clinical Pharmacokinetics and Pharmacodynamics of Glimepiride—A Systematic Review and Meta-Analysis Abstract Background/Objectives: Glimepiride (GLM), a commonly used sulphonylurea drug for the management of type 2 diabetes mellitus (T2DM), has been the subject of numerous studies exploring its kinetic behaviors. H...