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PMC11888580
core_pubmed_pmc
Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials
Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials Abstract Abstract While patient-reported outcome measures are regularly incorporated into phase 3 clinical trials, they have been infrequently used in early phase trials. However, the patient’s perspective is vital to f...
PMC8742635
core_pubmed_pmc
Evaluation of atezolizumab immunogenicity: Clinical pharmacology (part 1)
Evaluation of atezolizumab immunogenicity: Clinical pharmacology (part 1) Abstract Abstract Baseline patient characteristics and prognostic factors are important considerations in oncology when evaluating the impact of immunogenicity on pharmacokinetics (PK) and efficacy. Here, we assessed the impact of anti‐drug antib...
PMC11117394
core_pubmed_pmc
A Novel Approach to Integrate Human Biomonitoring Data with Model Predicted Dietary Exposures: A Crop Protection Chemical Case Study Using Lambda-Cyhalothrin
A Novel Approach to Integrate Human Biomonitoring Data with Model Predicted Dietary Exposures: A Crop Protection Chemical Case Study Using Lambda-Cyhalothrin Abstract Abstract The appropriate use of human biomonitoring data to model population chemical exposures is challenging, especially for rapidly metabolized chemic...
PMC7183132
core_pubmed_pmc
Volume kinetic analysis of fluid retention after induction of general anesthesia
Volume kinetic analysis of fluid retention after induction of general anesthesia Abstract Abstract Background Induction of general anesthesia increases the hemodilution resulting from infusion of crystalloid fluid, which is believed to be due to slower distribution caused by arterial hypotension. When normal distributi...
PMC12042691
core_pubmed_pmc
Exploring neuropharmacokinetics: mechanisms, models, and clinical implications
Exploring neuropharmacokinetics: mechanisms, models, and clinical implications Abstract Neuropharmacokinetics is an emerging field dedicated to understanding the pharmacokinetics of drugs within the central nervous system (CNS), with a particular emphasis on overcoming the challenges posed by the blood-brain barrier. T...
PMC4993270
core_pubmed_pmc
Pharmacokinetic profile of defibrotide in patients with renal impairment
Pharmacokinetic profile of defibrotide in patients with renal impairment Abstract Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication of hematopoietic stem cell transplant conditioning. Severe VOD/SOS, generally associated...
PMC12451837
core_pubmed_pmc
The Efficiency of Plant Extracts in the Prevention of Gastric Cancer: A Systematic Review
The Efficiency of Plant Extracts in the Prevention of Gastric Cancer: A Systematic Review Abstract ABSTRACT Background and Aims Gastric cancer is a global health concern with high morbidity and mortality. This systematic review evaluates the potential of plant extracts in the prevention of gastric cancer by analyzing t...
PMC12579074
core_pubmed_pmc
Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials
Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials Abstract Abstract Introduction Thyroid eye disease (TED) is a rare, autoimmune, orbital inflammatory disorder that is disfiguring, debilitating, and potentially sight-threatening. There is an...
PMC11252221
core_pubmed_pmc
Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes
Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes Abstract Abstract Obstructive hypertrophic cardiomyopathy (oHCM) is a subtype of HCM characterized by left ventricular outflow tract obstruction resulting from cardiac muscle hypertrophy and anatomic alterations ...
PMC9777743
core_pubmed_pmc
Dalbavancin in clinical practice in Spain: a 2 year retrospective study
Dalbavancin in clinical practice in Spain: a 2 year retrospective study Abstract Abstract Objectives Dalbavancin is approved for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) in adults. Its unique pharmacokinetic properties allow daily dosing to be avoided. The objective was to describe ...
PMC12467535
core_pubmed_pmc
In Vivo Characterization of ONL1204, a Small Peptide Inhibitor of the Fas Receptor, as a Potential Neuroprotective Therapy for Geographic Atrophy and Dry Age-Related Macular Degeneration
In Vivo Characterization of ONL1204, a Small Peptide Inhibitor of the Fas Receptor, as a Potential Neuroprotective Therapy for Geographic Atrophy and Dry Age-Related Macular Degeneration Abstract Background : Age-related macular degeneration (AMD) is a major cause of irreversible vision loss in the developed world, and...
PMC11944829
core_pubmed_pmc
A Narrative Review on Higenamine: Pharmacological Properties and Clinical Applications
A Narrative Review on Higenamine: Pharmacological Properties and Clinical Applications Abstract Background: Higenamine, a bioactive alkaloid derived from plants such as Aconitum and Annona squamosa , has been traditionally used in Chinese medicine for treating heart diseases like bradycardia, arrhythmia, and heart fail...
PMC11613628
core_pubmed_pmc
Covalent Targeting of Histidine Residues with Aryl Fluorosulfates: Application to Mcl-1 BH3 Mimetics
Covalent Targeting of Histidine Residues with Aryl Fluorosulfates: Application to Mcl-1 BH3 Mimetics Abstract Covalent drugs provide pharmacodynamic and pharmacokinetic advantages over reversible agents. However, covalent strategies have been developed mostly to target cysteine (Cys) residues, which are rarely found in...
PMC9325750
core_pubmed_pmc
A curated binary pattern multitarget dataset of focused ATP-binding cassette transporter inhibitors
A curated binary pattern multitarget dataset of focused ATP-binding cassette transporter inhibitors Abstract Multitarget datasets that correlate bioactivity landscapes of small-molecules toward different related or unrelated pharmacological targets are crucial for novel drug design and discovery. ATP-binding cassette (...
PMC4990596
core_pubmed_pmc
Tracking Cefoperazone/Sulbactam Resistance Development In vivo in A. baumannii Isolated from a Patient with Hospital-Acquired Pneumonia by Whole-Genome Sequencing
Tracking Cefoperazone/Sulbactam Resistance Development In vivo in A. baumannii Isolated from a Patient with Hospital-Acquired Pneumonia by Whole-Genome Sequencing Abstract Cefoperazone/sulbactam has been shown to be efficacious for the treatment of infections caused by Acinetobacter baumannii ; however, the mechanism u...
PMC6182466
core_pubmed_pmc
A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women
A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women Abstract Abstract Background Reducing the dose of efavirenz can improve safety, reduce costs, and increase access for patients with HIV infection. According to the World Health Organiz...
PMC6266947
core_pubmed_pmc
Pharmacokinetics of Sublingually Delivered Fentanyl in Head and Neck Cancer Patients Treated with Curatively Aimed Chemo or Bioradiotherapy
Pharmacokinetics of Sublingually Delivered Fentanyl in Head and Neck Cancer Patients Treated with Curatively Aimed Chemo or Bioradiotherapy Abstract Abstract Over 90% of patients treated for head and neck cancer with curatively aimed chemo or bioradiotherapy will develop painful mucositis and xerostomia. Sublingually d...
PMC7443729
core_pubmed_pmc
Optimization of flucloxacillin dosing regimens in critically ill patients using population pharmacokinetic modelling of total and unbound concentrations
Optimization of flucloxacillin dosing regimens in critically ill patients using population pharmacokinetic modelling of total and unbound concentrations Abstract Abstract Background Initial appropriate anti-infective therapy is associated with improved outcomes in patients with severe infections. In critically ill pati...
PMC8875672
core_pubmed_pmc
Development and Validation of Open-Source R Package HMCtdm for Therapeutic Drug Monitoring
Development and Validation of Open-Source R Package HMCtdm for Therapeutic Drug Monitoring Abstract Most therapeutic drug monitoring (TDM) packages are based on the maximum a posteriori (MAP) estimation. In this study, HMCtdm, a new TDM package, was developed using a Hamiltonian Monte Carlo (HMC) simulation. The estima...
PMC5768421
core_pubmed_pmc
Lactoferrin-modified rotigotine nanoparticles for enhanced nose-to-brain delivery: LESA-MS/MS-based drug biodistribution, pharmacodynamics, and neuroprotective effects
Lactoferrin-modified rotigotine nanoparticles for enhanced nose-to-brain delivery: LESA-MS/MS-based drug biodistribution, pharmacodynamics, and neuroprotective effects Abstract Abstract Introduction Efficient delivery of rotigotine into the brain is crucial for obtaining maximum therapeutic efficacy for Parkinson’s dis...
PMC5063153
core_pubmed_pmc
A thorough QTc study demonstrates that olmesartan medoxomil does not prolong the QTc interval
A thorough QTc study demonstrates that olmesartan medoxomil does not prolong the QTc interval Abstract Abstract Two studies (ROADMAP and ORIENT) evaluating the renoprotective effects of olmesartan medoxomil (OM) in patients with type 2 diabetes suggested OM is associated with increased cardiovascular mortality. We cond...
PMC10076747
core_pubmed_pmc
Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure
Drug exposure during pregnancy: Current understanding and approaches to measure maternal-fetal drug exposure Abstract Prescription drug use is prevalent during pregnancy, yet there is limited knowledge about maternal-fetal safety and efficacy of this drug use because pregnant individuals have historically been excluded...
PMC5004172
core_pubmed_pmc
Prions efficiently cross the intestinal barrier after oral administration: Study of the bioavailability, and cellular and tissue distribution in vivo
Prions efficiently cross the intestinal barrier after oral administration: Study of the bioavailability, and cellular and tissue distribution in vivo Abstract Abstract Natural forms of prion diseases frequently originate by oral (p.o.) infection. However, quantitative information on the gastro-intestinal (GI) absorptio...
PMC6270099
core_pubmed_pmc
Synthesis, Biological Evaluation, and Pharmacokinetic Study of Novel Liguzinediol Prodrugs
Synthesis, Biological Evaluation, and Pharmacokinetic Study of Novel Liguzinediol Prodrugs Abstract Abstract Liguzinediol (LZDO) ester prodrugs 3 – 5 were synthesized and evaluated in vitro and in vivo for their potential use in prolonging the half-life of the parent drug LZDO ( 1a ) in vivo . Prodrugs 3 – 5 were found...
PMC8026416
core_pubmed_pmc
Extrapolation of pharmacokinetics and pharmacodynamics of sunitinib in children with gastrointestinal stromal tumors
Extrapolation of pharmacokinetics and pharmacodynamics of sunitinib in children with gastrointestinal stromal tumors Abstract Abstract Purpose The starting dose of sunitinib in children with gastrointestinal stromal tumors (GIST) was extrapolated based on data in adults with GIST or solid tumors and children with solid...
PMC6603215
core_pubmed_pmc
Exploring the Use of Pegylated Liposomal Doxorubicin (Caelyx ® ) as Pressurized Intraperitoneal Aerosol Chemotherapy
Exploring the Use of Pegylated Liposomal Doxorubicin (Caelyx ® ) as Pressurized Intraperitoneal Aerosol Chemotherapy Abstract Abstract Background: Peritoneal carcinomatosis is a common metastatic pattern in ovarian, gastric, colorectal, and appendiceal cancer; systemic chemotherapy is the current standard of care for p...
PMC10135278
core_pubmed_pmc
All Roads Lead to Rome: Enhancing the Probability of Target Attainment with Different Pharmacokinetic/Pharmacodynamic Modelling Approaches
All Roads Lead to Rome: Enhancing the Probability of Target Attainment with Different Pharmacokinetic/Pharmacodynamic Modelling Approaches Abstract In light of rising antimicrobial resistance and a decreasing number of antibiotics with novel modes of action, it is of utmost importance to accelerate development of novel...
PMC6025247
core_pubmed_pmc
Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers
Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers Abstract Therapeutic doses of tedizolid phosphate, an oxazolidinone antibiotic, lack monoamine oxidase inhibition in vivo, potentially resulting in an improved safety profile versus other oxazolidinones. This ra...
PMC7932974
core_pubmed_pmc
Sphingosine 1-phosphate Receptor Modulator Therapy for Multiple Sclerosis: Differential Downstream Receptor Signalling and Clinical Profile Effects
Sphingosine 1-phosphate Receptor Modulator Therapy for Multiple Sclerosis: Differential Downstream Receptor Signalling and Clinical Profile Effects Abstract Lysophospholipids are a class of bioactive lipid molecules that produce their effects through various G protein-coupled receptors (GPCRs). Sphingosine 1-phosphate ...
PMC11647205
core_pubmed_pmc
First-in-Human Dose-Escalation Study of the First-in-Class PDE3A–SLFN12 Complex Inducer BAY 2666605 in Patients with Advanced Solid Tumors Coexpressing SLFN12 and PDE3A
First-in-Human Dose-Escalation Study of the First-in-Class PDE3A–SLFN12 Complex Inducer BAY 2666605 in Patients with Advanced Solid Tumors Coexpressing SLFN12 and PDE3A Abstract Abstract Purpose: The study aims to evaluate the safety, tolerability, and pharmacokinetics of BAY 2666605, a velcrin that induces complex for...
PMC11357179
core_pubmed_pmc
Guidance on Selecting Optimal Steady-State Tacrolimus Concentrations for Continuous IV Perfusion: Insights from Physiologically Based Pharmacokinetic Modeling
Guidance on Selecting Optimal Steady-State Tacrolimus Concentrations for Continuous IV Perfusion: Insights from Physiologically Based Pharmacokinetic Modeling Abstract Abstract Introduction : The dose–response relationships of tacrolimus have been primarily assessed through trough concentrations during intermittent adm...
PMC10215448
core_pubmed_pmc
The Antimicrobial Effects of Colistin Encapsulated in Chelating Complex Micelles for the Treatment of Multi-Drug-Resistant Gram-Negative Bacteria: A Pharmacokinetic Study
The Antimicrobial Effects of Colistin Encapsulated in Chelating Complex Micelles for the Treatment of Multi-Drug-Resistant Gram-Negative Bacteria: A Pharmacokinetic Study Abstract Abstract Background: Infections caused by multi-drug-resistant Gram-negative bacteria (MDR-GNB) are an emerging problem globally. Colistin i...
PMC11179703
core_pubmed_pmc
Quantitative evaluation of trastuzumab deruxtecan pharmacokinetics and pharmacodynamics in mouse models of varying degrees of HER2 expression
Quantitative evaluation of trastuzumab deruxtecan pharmacokinetics and pharmacodynamics in mouse models of varying degrees of HER2 expression Abstract Abstract Trastuzumab deruxtecan (T‐DXd; DS‐8201; ENHERTU®) is a human epithelial growth factor receptor 2 (HER2)‐directed antibody drug conjugate (ADC) with demonstrated...
PMC11204537
core_pubmed_pmc
Dosing Cefazolin for Surgical Site Infection Prophylaxis in Adolescent Idiopathic Scoliosis Surgery: Intermittent Bolus or Continuous Infusion?—A Pilot Study
Dosing Cefazolin for Surgical Site Infection Prophylaxis in Adolescent Idiopathic Scoliosis Surgery: Intermittent Bolus or Continuous Infusion?—A Pilot Study Abstract Abstract Background: Cefazolin may minimize the risk of surgical site infection (SSI) following posterior spinal fusion (PSF) for adolescent idiopathic s...
PMC9513393
core_pubmed_pmc
Revealing the mechanism of raw and vinegar-processed Curcuma aromatica Salisb. [Zingiberaceae] regulates primary dysmenorrhea in rats via integrated metabolomics
Revealing the mechanism of raw and vinegar-processed Curcuma aromatica Salisb. [Zingiberaceae] regulates primary dysmenorrhea in rats via integrated metabolomics Abstract Primary dysmenorrhea (PDM) is a common disorder among women around the world. Two processed products of Curcuma aromatica Salisb. [Zingiberaceae] (CA...
PMC8830040
core_pubmed_pmc
Population pharmacokinetic analysis and dosage recommendations for digoxin in Japanese patients with atrial fibrillation and heart failure using real-world data
Population pharmacokinetic analysis and dosage recommendations for digoxin in Japanese patients with atrial fibrillation and heart failure using real-world data Abstract Background Digoxin is an important treatment option for reducing the ventricular rate in patients with atrial fibrillation (AF) and heart failure (HF)...
PMC8093178
core_pubmed_pmc
Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors
Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors Abstract Abstract Background and Objective Population pharmacokinetic analysis explored the pharmacokinetics of sunitinib and its primary active metabolite, SU0126...
PMC4540731
core_pubmed_pmc
Are Physiologically Based Pharmacokinetic Models Reporting the Right C max ? Central Venous Versus Peripheral Sampling Site
Are Physiologically Based Pharmacokinetic Models Reporting the Right C max ? Central Venous Versus Peripheral Sampling Site Abstract Physiologically based pharmacokinetic (PBPK) models can over-predict maximum plasma concentrations (C max ) following intravenous administration. A proposed explanation is that invariably...
PMC3113376
core_pubmed_pmc
A comparative study of the pharmacokinetics of traditional and automated dosing/blood sampling systems using gabapentin
A comparative study of the pharmacokinetics of traditional and automated dosing/blood sampling systems using gabapentin Abstract Objective: The present study was undertaken to investigate the pharmacokinetics (PKs) of gabapentin as determined by traditional manual blood sampling and by using an automated dosing/blood s...
PMC8638037
core_pubmed_pmc
Individualized treatment of breast cancer with chronic renal failure: A case report and review of literature
Individualized treatment of breast cancer with chronic renal failure: A case report and review of literature Abstract BACKGROUND Studies have shown that patients with chronic renal failure (CRF) are more likely to suffer from breast cancer and other malignant tumors. To our knowledge, CRF can reduce drug excretion, the...
PMC6559177
core_pubmed_pmc
Preclinical in vivo characterization of lemborexant (E2006), a novel dual orexin receptor antagonist for sleep/wake regulation
Preclinical in vivo characterization of lemborexant (E2006), a novel dual orexin receptor antagonist for sleep/wake regulation Abstract Abstract Study Objectives To present results from in vivo studies underlying the preclinical development of lemborexant (E2006), a novel dual orexin (hypocretin) receptor antagonist fo...
PMC5880335
core_pubmed_pmc
Pharmacokinetics-adapted Busulfan-based myeloablative conditioning before unrelated umbilical cord blood transplantation for myeloid malignancies in children
Pharmacokinetics-adapted Busulfan-based myeloablative conditioning before unrelated umbilical cord blood transplantation for myeloid malignancies in children Abstract Abstract Unrelated umbilical cord blood transplantation (UCBT) is an alternative to provide transplants in children with acute leukemia or myelodysplasti...
PMC8886296
core_pubmed_pmc
Role of Dexamethasone and Methylprednisolone Corticosteroids in Coronavirus Disease 2019 Hospitalized Patients: A Review
Role of Dexamethasone and Methylprednisolone Corticosteroids in Coronavirus Disease 2019 Hospitalized Patients: A Review Abstract The WHO announced coronavirus disease 2019 (COVID-19) as a pandemic disease globally on March 11, 2020, after it emerged in China. The emergence of COVID-19 has lasted over a year, and despi...
PMC6189138
core_pubmed_pmc
Anti-tumour activity of a first-in-class agent NUC-1031 in patients with advanced cancer: results of a phase I study
Anti-tumour activity of a first-in-class agent NUC-1031 in patients with advanced cancer: results of a phase I study Abstract Abstract Background Gemcitabine is used to treat a wide range of tumours, but its efficacy is limited by cancer cell resistance mechanisms. NUC-1031, a phosphoramidate modification of gemcitabin...
PMC12594320
core_pubmed_pmc
A systematic comparison of patient information leaflets from local and multinational pharmaceutical companies: Assessing content quality and completeness
A systematic comparison of patient information leaflets from local and multinational pharmaceutical companies: Assessing content quality and completeness Abstract Abstract Background It is necessary to provide essential information to patients regarding medication to ensure safe and effective use. Patient Information L...
PMC5762495
core_pubmed_pmc
Development of an LC–MS/MS method for the quantitation of deoxyglycychloxazol in rat plasma and its application in pharmacokinetic study ☆
Development of an LC–MS/MS method for the quantitation of deoxyglycychloxazol in rat plasma and its application in pharmacokinetic study ☆ Abstract Abstract Deoxyglycychloxazol (TY501) is a glycyrrhetinic acid derivative which exhibits high anti-inflammatory activity and reduced pseudoaldosteronism compared to glycyrrh...
PMC6412143
core_pubmed_pmc
Pharmacokinetics and pharmacodynamics of a single dose Nilotinib in individuals with Parkinson's disease
Pharmacokinetics and pharmacodynamics of a single dose Nilotinib in individuals with Parkinson's disease Abstract Abstract Nilotinib is a broad‐based tyrosine kinase inhibitor with the highest affinity to inhibit Abelson (c‐Abl) and discoidin domain receptors (DDR1/2). Preclinical evidence indicates that Nilotinib redu...
PMC9303624
core_pubmed_pmc
Bimekizumab for the treatment of moderate‐to‐severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double‐blind multicentre study *
Bimekizumab for the treatment of moderate‐to‐severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double‐blind multicentre study * Abstract Summary Background Bimekizumab is a monoclonal antibody that selectively inhibits both interleukin (IL)‐1...
PMC7021089
core_pubmed_pmc
Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study
Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study Abstract Abstract Objectives To investigate pharmacokinetics (PK) and safety (primary objectives) and efficacy (secondary objective) of the investigati...
PMC3263649
core_pubmed_pmc
Variability in the Responsiveness to Low-Dose Aspirin: Pharmacological and Disease-Related Mechanisms
Variability in the Responsiveness to Low-Dose Aspirin: Pharmacological and Disease-Related Mechanisms Abstract Abstract The main pharmacological aspects of pharmacodynamics (PD) and pharmacokinetics (PK) of aspirin as antiplatelet agent were unravelled between the late sixties and the eighties, and low-dose aspirin giv...
PMC4874602
core_pubmed_pmc
Bedaquiline and Pyrazinamide Treatment Responses Are Affected by Pulmonary Lesion Heterogeneity in Mycobacterium tuberculosis Infected C3HeB/FeJ Mice
Bedaquiline and Pyrazinamide Treatment Responses Are Affected by Pulmonary Lesion Heterogeneity in Mycobacterium tuberculosis Infected C3HeB/FeJ Mice Abstract BALB/c and Swiss mice are routinely used to validate the effectiveness of tuberculosis drug regimens, although these mouse strains fail to develop human-like pul...
PMC9119441
core_pubmed_pmc
Clofoctol inhibits SARS-CoV-2 replication and reduces lung pathology in mice
Clofoctol inhibits SARS-CoV-2 replication and reduces lung pathology in mice Abstract Abstract Drug repurposing has the advantage of shortening regulatory preclinical development steps. Here, we screened a library of drug compounds, already registered in one or several geographical areas, to identify those exhibiting a...
PMC11434791
core_pubmed_pmc
Pharmacokinetic Models of Tafenoquine: Insights for Optimal Malaria Treatment Strategies
Pharmacokinetic Models of Tafenoquine: Insights for Optimal Malaria Treatment Strategies Abstract Tafenoquine (TQ) is a new 8-aminoquinoline antimalarial drug developed by the US Army for Plasmodium vivax malaria treatment. Modeling and simulation are essential tools for drug development and improving rationality in ph...
PMC6658769
core_pubmed_pmc
First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment
First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment Abstract This first-time-in-human (FTIH) study evaluated the safety, tolerability, pharmacokinetics, and food effect of single and repeat oral doses of GSK3036656,...
PMC12735571
core_pubmed_pmc
DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet
DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet Abstract Background/Objectives : This study explores the integration of Design of Experiments (DoE) with Physiologically Based Biopharmaceutics Modeling (PBBM) to streamline the development of extended-release (XR) formulations. Using ...
PMC8996404
core_pubmed_pmc
The pharmacokinetics of buserelin after intramuscular administration in pigs and cows
The pharmacokinetics of buserelin after intramuscular administration in pigs and cows Abstract Background Buserelin is a luteinizing hormone releasing hormone (LHRH) agonist used for the treatment of hormone-dependent diseases in males and females. However, the pharmacokinetics of buserelin in pigs and cows are not ful...
PMC11208791
core_pubmed_pmc
Quantification of Rhodojaponin II and Rhodojaponin III in Rat Plasma by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry
Quantification of Rhodojaponin II and Rhodojaponin III in Rat Plasma by Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry Abstract Abstract An ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed to determine the concentrations of Rhodojaponin II and Rhodojap...
PMC12043107
core_pubmed_pmc
Preclinical pharmacokinetics, distribution, metabolism and excretion of disitamab vedotin
Preclinical pharmacokinetics, distribution, metabolism and excretion of disitamab vedotin Abstract Abstract Background and purpose Disitamab vedotin is an antibody-drug conjugate (ADC) composed of a humanized IgG1 monoclonal antibody (mAb) targeting HER2 conjugated to monomethyl auristatin E(MMAE) via a cleavable dipep...
PMC9540401
core_pubmed_pmc
What is the value of faster acting prandial insulin? Focus on ultra rapid lispro
What is the value of faster acting prandial insulin? Focus on ultra rapid lispro Abstract Abstract Rapid‐acting insulins (RAIs) have been instrumental in the management of diabetes because of their improved postprandial glucose (PPG) control compared with regular human insulin. However, their absorption rate and time a...
PMC8672039
core_pubmed_pmc
Integrated Network Pharmacology and Lipidomics to Reveal the Inhibitory Effect of Qingfei Oral Liquid on Excessive Autophagy in RSV-Induced Lung Inflammation
Integrated Network Pharmacology and Lipidomics to Reveal the Inhibitory Effect of Qingfei Oral Liquid on Excessive Autophagy in RSV-Induced Lung Inflammation Abstract Abstract Background: Respiratory syncytial virus (RSV) can cause varying degrees of lung inflammation in children. Qingfei Oral Liquid (QF) is effective ...
PMC9545268
core_pubmed_pmc
Sexually transmitted doping: The impact of urine contamination of semen
Sexually transmitted doping: The impact of urine contamination of semen Abstract Abstract The high sensitivity of antidoping detection tests creates the possibility of inadvertent doping due to an athlete's unknowing ingestion of contaminated environmental sources such as dietary supplements, food, or drinks. Recently,...
PMC3738144
core_pubmed_pmc
Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer
Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer Abstract Background: This dose-finding study evaluated lenvatinib, an oral multitargeted receptor tyrosine kinase inhibitor, in combination with carboplatin/paclitaxel in chemotherapy-naïve non-small-cell lu...
PMC11495133
core_pubmed_pmc
On placental and lactational transfer of IgG‐based therapeutic proteins – Current understanding and knowledge gaps from a clinical pharmacology perspective
On placental and lactational transfer of IgG‐based therapeutic proteins – Current understanding and knowledge gaps from a clinical pharmacology perspective Abstract Abstract Maternal medication use may expose the developing fetus through placental transfer or the infant through lactational transfer. Because pregnant an...
PMC11701965
core_pubmed_pmc
A Phase 1 Study to Evaluate the Pharmacokinetic Drug‐Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy
A Phase 1 Study to Evaluate the Pharmacokinetic Drug‐Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy Abstract Abstract Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV‐1. People living with HIV‐1 receiving meth...
PMC5131886
core_pubmed_pmc
Bridging Sunitinib Exposure to Time‐to‐Tumor Progression in Hepatocellular Carcinoma Patients With Mathematical Modeling of an Angiogenic Biomarker
Bridging Sunitinib Exposure to Time‐to‐Tumor Progression in Hepatocellular Carcinoma Patients With Mathematical Modeling of an Angiogenic Biomarker Abstract Hepatocellular carcinoma (HCC) is third in cancer‐related causes of death worldwide and its treatment is a significant unmet medical need. Sunitinib is a selective...
PMC5116175
core_pubmed_pmc
Estimation of tulathromycin depletion in plasma and milk after subcutaneous injection in lactating goats using a nonlinear mixed-effects pharmacokinetic modeling approach
Estimation of tulathromycin depletion in plasma and milk after subcutaneous injection in lactating goats using a nonlinear mixed-effects pharmacokinetic modeling approach Abstract Background Extra-label use of tulathromycin in lactating goats is common and may cause violative residues in milk. The objective of this stu...
PMC11191404
core_pubmed_pmc
Reversible Chemical Modification of Antibody Effector Function Mitigates Unwanted Systemic Immune Activation
Reversible Chemical Modification of Antibody Effector Function Mitigates Unwanted Systemic Immune Activation Abstract Abstract Antibody effector functions including antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP) are mediated through the interaction of the antibody Fc region with Fcγ receptors p...
PMC12625083
core_pubmed_pmc
Postmarketing Assessment of Antibody–Drug Conjugates: Proof‐of‐Concept Using Model‐Based Meta‐Analysis and a Clinical Utility Index Approach
Postmarketing Assessment of Antibody–Drug Conjugates: Proof‐of‐Concept Using Model‐Based Meta‐Analysis and a Clinical Utility Index Approach Abstract ABSTRACT Antibody–drug conjugates (ADCs) are a promising class of targeted cancer therapies. However, they need careful dose optimization to maximize effectiveness and mi...
PMC11898576
core_pubmed_pmc
Anticholinesterase and carbonic anhydrase inhibitory activities of natural carnosic acid derivatives: A comprehensive in vitro and in silico study
Anticholinesterase and carbonic anhydrase inhibitory activities of natural carnosic acid derivatives: A comprehensive in vitro and in silico study Abstract Abstract This study investigates the anticholinesterase (acetylcholinesterase [AChE] and butyrylcholinesterase [BChE]) and carbonic anhydrase (CAI and CAII) inhibit...
PMC4981156
core_pubmed_pmc
Quantification of simvastatin in mice plasma by near-infrared and chemometric analysis of spectral data
Quantification of simvastatin in mice plasma by near-infrared and chemometric analysis of spectral data Abstract Time and cost saving is an essential requirement in pharmacokinetics and bioequivalence studies. The aim of this study is to use a simple, fast, and nondestructive near-infrared transmission spectroscopic me...
PMC8228202
core_pubmed_pmc
Pharmacokinetics and Pharmacodynamics of Meropenem by Extended or Continuous Infusion in Low Body Weight Critically Ill Patients
Pharmacokinetics and Pharmacodynamics of Meropenem by Extended or Continuous Infusion in Low Body Weight Critically Ill Patients Abstract Abstract Background : Pathophysiological changes such as extreme body weights in critically ill patients with severe infections may alter the pharmacokinetics (PK) of antimicrobials,...
PMC8926166
core_pubmed_pmc
Pharmacometric Analysis of Intranasal and Intravenous Nalbuphine to Optimize Pain Management in Infants
Pharmacometric Analysis of Intranasal and Intravenous Nalbuphine to Optimize Pain Management in Infants Abstract Abstract Objectives The objective of this pharmacometric (PMX) study was to (i) characterize population pharmacokinetics (PPK) and exposure-pain response associations following intranasal (0.1 mg/kg) or intr...
PMC9417013
core_pubmed_pmc
Molecular docking, simulation and binding free energy analysis of small molecules as Pf HT1 inhibitors
Molecular docking, simulation and binding free energy analysis of small molecules as Pf HT1 inhibitors Abstract Abstract Antimalarial drug resistance has thrown a spanner in the works of malaria elimination. New drugs are required for ancillary support of existing malaria control efforts. Plasmodium falciparum requires...
PMC4462042
core_pubmed_pmc
GHB Pharmacology and Toxicology: Acute Intoxication, Concentrations in Blood and Urine in Forensic Cases and Treatment of the Withdrawal Syndrome
GHB Pharmacology and Toxicology: Acute Intoxication, Concentrations in Blood and Urine in Forensic Cases and Treatment of the Withdrawal Syndrome Abstract Abstract The illicit recreational drug of abuse, γ-hydroxybutyrate (GHB) is a potent central nervous system depressant and is often encountered during forensic inves...
PMC9818079
core_pubmed_pmc
Adherence to the CDK 4/6 Inhibitor Palbociclib and Omission of Dose Management Supported by Pharmacometric Modelling as Part of the OpTAT Study
Adherence to the CDK 4/6 Inhibitor Palbociclib and Omission of Dose Management Supported by Pharmacometric Modelling as Part of the OpTAT Study Abstract Simple Summary Medication adherence to CDK4/6 inhibitors such as palbociclib, prescribed as a cyclic oral anticancer therapy in women diagnosed with advanced breast ca...
PMC12281427
core_pubmed_pmc
Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor
Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor Abstract Summary Cadherin 17 (CDH17) has emerged as a promising target for gastrointestinal (GI) cancers, which are often complicated by multidrug resistance (MDR) and recurrence. In this st...
PMC7996972
core_pubmed_pmc
TBDBT: A TB DataBase Template for collection of harmonized TB clinical research data in REDCap, facilitating data standardisation for inter-study comparison and meta-analyses
TBDBT: A TB DataBase Template for collection of harmonized TB clinical research data in REDCap, facilitating data standardisation for inter-study comparison and meta-analyses Abstract Clinical tuberculosis research, both within research groups and across research ecosystems, is often undertaken in isolation using bespo...
PMC11648756
core_pubmed_pmc
Complex immunogenicity assessment in caplacizumab-treated patients with immune-mediated thrombotic thrombocytopenic purpura who have received plasma exchange
Complex immunogenicity assessment in caplacizumab-treated patients with immune-mediated thrombotic thrombocytopenic purpura who have received plasma exchange Abstract Background International Society on Thrombosis and Haemostasis guidelines for immune-mediated thrombotic thrombocytopenic purpura (iTTP) treatment recomm...
PMC10060561
core_pubmed_pmc
Acori Tatarinowii Rhizoma: A comprehensive review of its chemical composition, pharmacology, pharmacokinetics and toxicity
Acori Tatarinowii Rhizoma: A comprehensive review of its chemical composition, pharmacology, pharmacokinetics and toxicity Abstract Acori Tatarinowii Rhizoma (ATR, Shi Chang Pu in Chinese), a natural product with multiple targets in various diseases. This review provides the comprehensive summary of the chemical compos...
PMC5861163
core_pubmed_pmc
Analysis of different innovative formulations of curcumin for improved relative oral bioavailability in human subjects
Analysis of different innovative formulations of curcumin for improved relative oral bioavailability in human subjects Abstract Abstract Purpose The optimal health benefits of curcumin are limited by its low solubility in water and corresponding poor intestinal absorption. Cyclodextrins (CD) can form inclusion complexe...
PMC11333285
core_pubmed_pmc
Inhibition of lysine acetyltransferase KAT6 in ER + HER2 − metastatic breast cancer: a phase 1 trial
Inhibition of lysine acetyltransferase KAT6 in ER + HER2 − metastatic breast cancer: a phase 1 trial Abstract Abstract Inhibition of histone lysine acetyltransferases (KATs) KAT6A and KAT6B has shown antitumor activity in estrogen receptor-positive (ER + ) breast cancer preclinical models. PF-07248144 is a selective ca...
PMC4715838
core_pubmed_pmc
Caffeine enhances the antidepressant-like activity of common antidepressant drugs in the forced swim test in mice
Caffeine enhances the antidepressant-like activity of common antidepressant drugs in the forced swim test in mice Abstract Abstract Caffeine is the most widely used behaviorally active drug in the world which exerts its activity on central nervous system through adenosine receptors. Worrying data indicate that excessiv...
PMC8948897
core_pubmed_pmc
Growth Optimization and Secondary Metabolites Evaluation of Anabaena variabilis for Acetylcholinesterase Inhibition Activity
Growth Optimization and Secondary Metabolites Evaluation of Anabaena variabilis for Acetylcholinesterase Inhibition Activity Abstract Abstract Cyanobacteria comprise a good natural resource of a potential variety of neuro-chemicals, including acetylcholinesterase inhibitors essential for Alzheimer’s disease treatment. ...
PMC9316855
core_pubmed_pmc
Synthesis and Systematic Study on the Effect of Different PEG Units on Stability of PEGylated, Integrin-αvβ6-Specific A20FMDV2 Analogues in Rat Serum and Human Plasma
Synthesis and Systematic Study on the Effect of Different PEG Units on Stability of PEGylated, Integrin-αvβ6-Specific A20FMDV2 Analogues in Rat Serum and Human Plasma Abstract A20FMDV2 is a 20-mer peptide that exhibits high selectivity and affinity for the tumour-related αvβ6 integrin that can compete with extracellula...
PMC12035591
core_pubmed_pmc
Pharmacokinetic characterization and exposure–response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria
Pharmacokinetic characterization and exposure–response relationship of crovalimab in the COMMODORE 1, 2 and 3 and COMPOSER trials of patients with paroxysmal nocturnal haemoglobinuria Abstract Abstract Aims Crovalimab is a novel C5 inhibitor administered first intravenously and then subcutaneously in patients with paro...
PMC7341313
core_pubmed_pmc
Anthelmintic Efficacy and Pharmacokinetics of Ivermectin Paste after Oral Administration in Mules Infected by Cyathostomins
Anthelmintic Efficacy and Pharmacokinetics of Ivermectin Paste after Oral Administration in Mules Infected by Cyathostomins Abstract Abstract Simple Summary Mules and donkeys are often treated as horses from a therapeutic point of view. This approach could be dangerous due to species differences in drug pharmacokinetic...
PMC5021044
core_pubmed_pmc
Dose‐escalation study of tabalumab with bortezomib and dexamethasone in Japanese patients with multiple myeloma
Dose‐escalation study of tabalumab with bortezomib and dexamethasone in Japanese patients with multiple myeloma Abstract B‐cell activating factor ( BAFF ) promotes the survival and adhesion of multiple myeloma ( MM ) cells. Tabalumab ( LY 2127399) is an anti‐ BAFF monoclonal antibody. This phase 1, multicenter, open‐la...
PMC11098162
core_pubmed_pmc
Pharmacokinetics and exposure–safety relationship of ciprofol for sedation in mechanically ventilated patients in the intensive care unit
Pharmacokinetics and exposure–safety relationship of ciprofol for sedation in mechanically ventilated patients in the intensive care unit Abstract Abstract Ciprofol (HSK3486) is a newly developed, highly selective γ‐aminobutyric acid‐A (GABA A ) receptor potentiator that is recently approved for a new indication of sed...
PMC10087067
core_pubmed_pmc
Characterizing complex and competing drug–drug interactions between the antiviral regimen of glecaprevir and pibrentasvir with rifampin or carbamazepine
Characterizing complex and competing drug–drug interactions between the antiviral regimen of glecaprevir and pibrentasvir with rifampin or carbamazepine Abstract Abstract The fixed‐dose combination of the direct acting antivirals glecaprevir (GLE) and pibrentasvir (PIB) is an oral, once‐daily treatment for all six majo...
PMC3758109
core_pubmed_pmc
Efficient 18 F-Labeling of Synthetic Exendin-4 Analogues for Imaging Beta Cells
Efficient 18 F-Labeling of Synthetic Exendin-4 Analogues for Imaging Beta Cells Abstract A number of exendin derivatives have been developed to target glucagon-like peptide 1 (GLP-1) receptors on beta cells in vivo. Modifications of exendin analogues have been shown to have significant effects on pharmacokinetics and, ...
PMC4577263
core_pubmed_pmc
Improvement of fluvastatin bioavailability by loading on nanostructured lipid carriers
Improvement of fluvastatin bioavailability by loading on nanostructured lipid carriers Abstract Abstract The aim of this study is to prepare fluvastatin nanostructured lipid carriers (FLV-NLCs) in order to find an innovative way to alleviate FLV-associated disadvantages. The limitations include poor solubility and exte...
PMC11938982
core_pubmed_pmc
NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design
NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design Abstract ABSTRACT This is a single arm, open label trial to assess the safety and efficacy of NALIRIFOX in Japanese participants who have not previously received therapy for metastatic adenocar...
PMC7719369
core_pubmed_pmc
hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects
hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects Abstract A low lymphocyte count puts immune‐compromised patients at risk of mortality. hIL‐7‐hyFc is a homodimeric interleukin‐7 (IL‐7), a potent T‐cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performe...
PMC10050386
core_pubmed_pmc
Population PK/PD modelling of meropenem in preterm newborns based on therapeutic drug monitoring data
Population PK/PD modelling of meropenem in preterm newborns based on therapeutic drug monitoring data Abstract Background: Preterm neonates rarely participate in clinical trials, this leads to lack of adequate information on pharmacokinetics for most drugs in this population. Meropenem is used in neonates to treat seve...
PMC11173459
core_pubmed_pmc
The Discovery of Selective Protein Arginine Methyltransferase 5 Inhibitors in the Management of β-Thalassemia through Computational Methods
The Discovery of Selective Protein Arginine Methyltransferase 5 Inhibitors in the Management of β-Thalassemia through Computational Methods Abstract Abstract β-Thalassemia is an inherited genetic disorder associated with β-globin chain synthesis, which ultimately becomes anemia. Adenosine-2,3-dialdehyde, by inhibiting ...
PMC3743329
core_pubmed_pmc
A quick review of carbamazepine pharmacokinetics in epilepsy from 1953 to 2012
A quick review of carbamazepine pharmacokinetics in epilepsy from 1953 to 2012 Abstract Background: Carbamazepine has been used as AEDs since 1965, and is most effective against partial seizures. Two basic mechanisms of action have been proposed: 1) enhancement of sodium channel inactivation by reducing high-frequency ...
PMC6175298
core_pubmed_pmc
A Randomized, First‐in‐Human, Healthy Volunteer Trial of sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway
A Randomized, First‐in‐Human, Healthy Volunteer Trial of sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway Abstract Aberrant activation of the classical complement pathway is the common underlying pathophysiology of orphan diseases such as bullous pemphigoid, antibody‐medi...
PMC3207826
core_pubmed_pmc
Phase I Evaluation of STA-1474, a Prodrug of the Novel HSP90 Inhibitor Ganetespib, in Dogs with Spontaneous Cancer
Phase I Evaluation of STA-1474, a Prodrug of the Novel HSP90 Inhibitor Ganetespib, in Dogs with Spontaneous Cancer Abstract Abstract Background The novel water soluble compound STA-1474 is metabolized to ganetespib (formerly STA-9090), a potent HSP90 inhibitor previously shown to kill canine tumor cell lines in vitro a...
PMC5512459
core_pubmed_pmc
Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S
Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S Abstract Abstract Major histocompatibility complex class II (MHCII)-restricted antigen priming of CD4 + T cells is both involved in adaptive immune responses and the pathogenesis of autoimmune diseases. Degradation of invariant chain Ii,...
PMC8172506
core_pubmed_pmc
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial Abstract Abstract This study aimed to illustrate how a new methodology to assess clinical trial outcome measures using a longitudinal item response theory–based model (IRM) could serve as an ...