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PMC5686250
core_pubmed_pmc
A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer
A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer Abstract Purpose Mesenchymal–epithelial transition factor (MET) is expressed in gastric cancer and associated with poor clinical outcomes. We assessed activity, safety, and pha...
PMC5320046
core_pubmed_pmc
Evaluation of impact of anti-idursulfase antibodies during long-term idursulfase enzyme replacement therapy in mucopolysaccharidosis II patients
Evaluation of impact of anti-idursulfase antibodies during long-term idursulfase enzyme replacement therapy in mucopolysaccharidosis II patients Abstract Abstract Objectives This 109-week, nonrandomized, observational study of mucopolysaccharidosis II (MPS II) patients already enrolled in the Hunter Outcome Survey (HOS...
PMC12423794
core_pubmed_pmc
Exploration of the Mechanism of Ginkgo biloba Leaves Targeted Angiogenesis against Gastric Cancer
Exploration of the Mechanism of Ginkgo biloba Leaves Targeted Angiogenesis against Gastric Cancer Abstract Abstract Gastric cancer (GC), the fifth most prevalent malignancy worldwide, is the fifth leading cause of cancer-related deaths. Angiogenesis, the formation of new blood vessels from preexisting vasculature, play...
PMC4295025
core_pubmed_pmc
Phase 1 combination study of Eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer
Phase 1 combination study of Eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer Abstract Summary Eribulin mesylate (Halaven®) is a novel inhibitor of microtubule dynamics that has demonstrated a survival benefit in patients with locally recurrent...
PMC3396388
core_pubmed_pmc
Folate-targeted docetaxel-lipid-based-nanosuspensions for active-targeted cancer therapy
Folate-targeted docetaxel-lipid-based-nanosuspensions for active-targeted cancer therapy Abstract The purpose of this study was to develop two novel drug delivery systems based on biodegradable docetaxel-lipid-based-nanosuspensions. The first one was poly(ethylene glycol)- modified docetaxel-lipid-based-nanosuspensions...
PMC11015041
core_pubmed_pmc
Radiopharmaceutical transport in solid tumors via a 3-dimensional image-based spatiotemporal model
Radiopharmaceutical transport in solid tumors via a 3-dimensional image-based spatiotemporal model Abstract Abstract Lutetium-177 prostate-specific membrane antigen ( 177 Lu-PSMA)-targeted radiopharmaceutical therapy is a clinically approved treatment for patients with metastatic castration-resistant prostate cancer (m...
PMC11851862
core_pubmed_pmc
Could a Reduced Dose of 8 g of Continuous Infusion Fosfomycin Be Considered as Effective as and Safer than a Standard 16 g Dose When Combined with High-Dose Daptomycin in the Treatment of Staphylococcal osteoarticular Infections?
Could a Reduced Dose of 8 g of Continuous Infusion Fosfomycin Be Considered as Effective as and Safer than a Standard 16 g Dose When Combined with High-Dose Daptomycin in the Treatment of Staphylococcal osteoarticular Infections? Abstract Background : Daptomycin plus fosfomycin combination therapy is a valuable strateg...
PMC6554177
core_pubmed_pmc
Double-Blind Randomized Clinical Trial to Examine the Pharmacokinetic and Clinical Impacts of Fixed Dose versus Weight-based Enoxaparin Prophylaxis: A Methodologic Description of the FIxed or Variable Enoxaparin (FIVE) Trial
Double-Blind Randomized Clinical Trial to Examine the Pharmacokinetic and Clinical Impacts of Fixed Dose versus Weight-based Enoxaparin Prophylaxis: A Methodologic Description of the FIxed or Variable Enoxaparin (FIVE) Trial Abstract Abstract Venous thromboembolism is an important patient safety in plastic surgery, and...
PMC6009244
core_pubmed_pmc
Pharmacokinetic characteristics of antiepileptic drugs (AEDs)
Pharmacokinetic characteristics of antiepileptic drugs (AEDs) Abstract Antiepileptic drugs (AEDs) are routinely prescribed for the management of a variety of neurologic and psychiatric conditions, including epilepsy and epilepsy syndromes. Physiologic changes due to aging, pregnancy, nutritional status, drug interactio...
PMC10787199
core_pubmed_pmc
Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non‐small cell lung cancer based on bintrafusp alfa trials
Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non‐small cell lung cancer based on bintrafusp alfa trials Abstract Abstract This analysis aimed to quantify tumor dynamics in patients receiving either bintrafusp alfa (BA) or pembrolizumab, by population pharmacokinetic ...
PMC7212776
core_pubmed_pmc
Investigation of the Inhibitory Effect of Simvastatin on the Metabolism of Lidocaine Both in vitro and in vivo
Investigation of the Inhibitory Effect of Simvastatin on the Metabolism of Lidocaine Both in vitro and in vivo Abstract Background Lidocaine has cardiovascular and neurologic toxicity, which is dose-dependent. Due to CYP3A4-involved metabolism, lidocaine may be prone to drug–drug interactions. Materials and Methods Giv...
PMC8698565
core_pubmed_pmc
A Use of Tritium-Labeled Peat Fulvic Acids and Polyphenolic Derivatives for Designing Pharmacokinetic Experiments on Mice
A Use of Tritium-Labeled Peat Fulvic Acids and Polyphenolic Derivatives for Designing Pharmacokinetic Experiments on Mice Abstract Abstract Natural products (e.g., polyphenols) have been used as biologically active compounds for centuries. Still, the mechanisms of biological activity of these multicomponent systems are...
PMC7652808
core_pubmed_pmc
The influence of cardiac output on propofol and fentanyl pharmacokinetics and pharmacodynamics in patients undergoing abdominal aortic surgery
The influence of cardiac output on propofol and fentanyl pharmacokinetics and pharmacodynamics in patients undergoing abdominal aortic surgery Abstract Cardiac output (CO) is expected to affect elimination and distribution of highly extracted and perfusion rate-limited drugs. This work was undertaken to quantify the ef...
PMC6899533
core_pubmed_pmc
Pharmacokinetics of Once‐Daily Extended‐Release Tacrolimus Tablets Versus Twice‐Daily Capsules in De Novo Liver Transplant
Pharmacokinetics of Once‐Daily Extended‐Release Tacrolimus Tablets Versus Twice‐Daily Capsules in De Novo Liver Transplant Abstract Abstract The pharmacokinetics of once‐daily extended‐release tacrolimus tablets (LCPT) in de novo liver transplantation have not been previously reported. In this phase II, randomized, ope...
PMC8501344
core_pubmed_pmc
The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin
The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin Abstract The epidemiology of invasive fungal infections is changing, with new populations at risk and the emergence of resistance caused by the selective pressure from increased usage of antifungal agents in prophylaxis, empiri...
PMC11706423
core_pubmed_pmc
A model‐based approach using GSK3772847, an anti‐interleukin‐33 receptor monoclonal antibody, as a showcase to predict SC administration PK and free target dynamics based on PK and total target measurements after IV administration
A model‐based approach using GSK3772847, an anti‐interleukin‐33 receptor monoclonal antibody, as a showcase to predict SC administration PK and free target dynamics based on PK and total target measurements after IV administration Abstract Abstract Integrated modeling of the pharmacokinetic (PK) and target binding, by ...
PMC9660663
core_pubmed_pmc
INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-bas...
INSTIs for the management of HIV-associated TB (INSIGHT study): a phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of bictegravir, emtricitabine and tenofovir alafenamide fumarate for the treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a rifampicin-bas...
PMC8473721
core_pubmed_pmc
In vivo Pharmacokinetic and Anticancer Studies of HH-N25, a Selective Inhibitor of Topoisomerase I, and Hormonal Signaling for Treating Breast Cancer
In vivo Pharmacokinetic and Anticancer Studies of HH-N25, a Selective Inhibitor of Topoisomerase I, and Hormonal Signaling for Treating Breast Cancer Abstract Purpose Breast cancer is the most frequently diagnosed cancer globally, and the leading cause of cancer-associated mortality among women. The efficacy of most cl...
PMC8913178
core_pubmed_pmc
Design of a Prospective Study on Pharmacokinetic-Guided Dosing of Prophylactic Factor Replacement in Hemophilia A and B (OPTI-CLOT TARGET Study)
Design of a Prospective Study on Pharmacokinetic-Guided Dosing of Prophylactic Factor Replacement in Hemophilia A and B (OPTI-CLOT TARGET Study) Abstract Abstract In resource-rich countries, almost all severe hemophilia patients receive prophylactic replacement therapy with factor concentrates to prevent spontaneous bl...
PMC7471407
core_pubmed_pmc
Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation
Population pharmacokinetics of cyclosporine in Chinese children receiving hematopoietic stem cell transplantation Abstract Abstract Cyclosporine (CsA) is characterized by a narrow therapeutic window and high interindividual pharmacokinetic variability, particularly in juvenile patients. The aims of this study were to b...
PMC6584114
core_pubmed_pmc
Metabolism of IMM-H004 and Its Pharmacokinetic-Pharmacodynamic Analysis in Cerebral Ischemia/Reperfusion Injured Rats
Metabolism of IMM-H004 and Its Pharmacokinetic-Pharmacodynamic Analysis in Cerebral Ischemia/Reperfusion Injured Rats Abstract Abstract IMM-H004, a derivative of coumarin, is a promising candidate for the treatment of cerebral ischemia. The pharmacodynamic mechanisms of IMM-H004 are still under exploration. The present...
PMC8326894
core_pubmed_pmc
Preclinical Safety Assessment and Toxicokinetics of Apitegromab, an Antibody Targeting Proforms of Myostatin for the Treatment of Muscle-Atrophying Disease
Preclinical Safety Assessment and Toxicokinetics of Apitegromab, an Antibody Targeting Proforms of Myostatin for the Treatment of Muscle-Atrophying Disease Abstract Myostatin is a negative regulator of skeletal muscle and has become a therapeutic target for muscle atrophying disorders. Although previous inhibitors of m...
PMC2905291
core_pubmed_pmc
A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours
A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours Abstract Abstract Background: This phase I study assessed the maximum tolerated dose, dose-limiting toxicity (DLT) and pharmaco...
PMC10583243
core_pubmed_pmc
Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma
Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma Abstract Abstract Belantamab mafodotin, a monomethyl auristatin F (MMAF)–containing monoclonal antibody‐drug conjugate (ADC), demonstrated deep and durable responses in the...
PMC12114779
core_pubmed_pmc
Nanoparticles and Nanomaterials: A Review from the Standpoint of Pharmacy and Medicine
Nanoparticles and Nanomaterials: A Review from the Standpoint of Pharmacy and Medicine Abstract Abstract Nanoparticles (NPs) represent a unique class of structures in the modern world. In comparison to macro- and microparticles, NPs exhibit advantages due to their physicochemical properties. This has resulted in their ...
PMC10060059
core_pubmed_pmc
Assessment of DOAC in GEriatrics ( Adage Study): Rivaroxaban/Apixaban Concentrations and Thrombin Generation Profiles in NVAF Very Elderly Patients
Assessment of DOAC in GEriatrics ( Adage Study): Rivaroxaban/Apixaban Concentrations and Thrombin Generation Profiles in NVAF Very Elderly Patients Abstract Background Although a growing number of very elderly patients with atrial fibrillation (AF), multiple conditions, and polypharmacy receive direct oral anticoagulan...
PMC10609842
core_pubmed_pmc
Computational Amendment of Parenteral In Situ Forming Particulates’ Characteristics: Design of Experiment and PBPK Physiological Modeling
Computational Amendment of Parenteral In Situ Forming Particulates’ Characteristics: Design of Experiment and PBPK Physiological Modeling Abstract Abstract Lipid and/or polymer-based drug conjugates can potentially minimize side effects by increasing drug accumulation at target sites and thus augment patient compliance...
PMC11142126
core_pubmed_pmc
Identification of Small Molecule Inhibitors of PPM1D Using a Novel Drug Discovery Platform
Identification of Small Molecule Inhibitors of PPM1D Using a Novel Drug Discovery Platform Abstract Protein phosphatase, Mg 2+ /Mn 2+ dependent 1D (PPM1D), is a serine/threonine phosphatase that is recurrently activated in cancer, regulates the DNA damage response (DDR), and suppresses the activation of p53. Consistent...
PMC7894007
core_pubmed_pmc
Prospective evaluation and refinement of an S‐1 dosage formula based on renal function for clinical application
Prospective evaluation and refinement of an S‐1 dosage formula based on renal function for clinical application Abstract Abstract In patients with impaired renal function, S‐1–related toxicities increase due to higher exposure of 5‐fluorouracil (5‐FU). Our previous pharmacokinetic study in 16 cancer patients with vario...
PMC8838925
core_pubmed_pmc
Pharmacokinetics of PEGylated Gold Nanoparticles: In Vitro—In Vivo Correlation
Pharmacokinetics of PEGylated Gold Nanoparticles: In Vitro—In Vivo Correlation Abstract Data suitable for assembling a physiologically-based pharmacokinetic (PBPK) model for nanoparticles (NPs) remain relatively scarce. Therefore, there is a trend in extrapolating the results of in vitro and in silico studies to in viv...
PMC9772744
core_pubmed_pmc
Effect of obesity on dolutegravir exposure in Black Southern African adults living with HIV
Effect of obesity on dolutegravir exposure in Black Southern African adults living with HIV Abstract Abstract Background Dolutegravir, a component of the preferred first-line antiretroviral therapy regimen, has been associated with increased weight gain. South Africa has a high prevalence of obesity, especially among w...
PMC9450039
core_pubmed_pmc
Utility of Intravenous Curcumin Nanodelivery Systems for Improving In Vivo Pharmacokinetics and Anticancer Pharmacodynamics
Utility of Intravenous Curcumin Nanodelivery Systems for Improving In Vivo Pharmacokinetics and Anticancer Pharmacodynamics Abstract Abstract Curcumin nanoformulations for intravenous injection have been developed to offset poor absorption, biotransformation, degradation, and excessive clearance associated with parente...
PMC8985255
core_pubmed_pmc
Dose-finding studies in drug development for rare genetic diseases
Dose-finding studies in drug development for rare genetic diseases Abstract Background The small patient populations inherent to rare genetic diseases present many challenges to the traditional drug development paradigm. One major challenge is generating sufficient data in early phase studies to inform dose selection f...
PMC12034916
core_pubmed_pmc
Evaluation of Cannabis Per Se Laws: A Semi‐Mechanistic Pharmacometrics Model for Quantitative Characterization of THC and Metabolites in Oral Users
Evaluation of Cannabis Per Se Laws: A Semi‐Mechanistic Pharmacometrics Model for Quantitative Characterization of THC and Metabolites in Oral Users Abstract Abstract Recreational cannabis use has increased notably in the United States in the past decade, with a recent surge in oral consumption. This trend has raised co...
PMC10383650
core_pubmed_pmc
Population Pharmacokinetics of Difloxacin in Crucian Carp ( Carassius auratus ) after a Single Oral Administration
Population Pharmacokinetics of Difloxacin in Crucian Carp ( Carassius auratus ) after a Single Oral Administration Abstract Simple Summary Crucian carp ( Carassius auratus ) is a freshwater fish that is popular due to its high nutritional value and delicious taste. It has become one of the most commonly farmed fish spe...
PMC6618124
core_pubmed_pmc
Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs
Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs Abstract Abstract Background Although reproducibility is considered essential for any method used in scientific research, it is investigated only rarely; thus, strikingly little has been published regarding the...
PMC6448330
core_pubmed_pmc
Pharmacokinetic Study of Delavinone in Mice after Intravenous and Oral Administration by UPLC-MS/MS
Pharmacokinetic Study of Delavinone in Mice after Intravenous and Oral Administration by UPLC-MS/MS Abstract Abstract Thirty-one compounds, including delavinone, were isolated from the methanol extract of F. cirrhosa by modern chromatographic techniques. The pharmacological action of Fritillaria is widely used in clini...
PMC8921073
core_pubmed_pmc
In vitro Dissolution Testing and Pharmacokinetic Studies of Silymarin Solid Dispersion After Oral Administration to Healthy Pigs
In vitro Dissolution Testing and Pharmacokinetic Studies of Silymarin Solid Dispersion After Oral Administration to Healthy Pigs Abstract We evaluated the pharmacokinetics of silymarin solid dispersion in pigs to determine whether silybin bioavailability would be increased over that of a silymarin premix. In vitro diss...
PMC10200060
core_pubmed_pmc
Inhibition of DAMP actions in the tumoral microenvironment using lactoferrin-glycyrrhizin conjugate for glioblastoma therapy
Inhibition of DAMP actions in the tumoral microenvironment using lactoferrin-glycyrrhizin conjugate for glioblastoma therapy Abstract Background High-mobility group box-1 (HMGB1) released from the tumor microenvironment plays a pivotal role in the tumor progression. HMGB1 serves as a damaged-associated molecular patter...
PMC7058098
core_pubmed_pmc
Pulmonary Administration: Strengthening the Value of Therapeutic Proximity
Pulmonary Administration: Strengthening the Value of Therapeutic Proximity Abstract In recent years inhaled systems have shown momentum as patient-personalized therapies emerge. A significant improvement in terms of therapeutic efficacy and/or reduction adverse systemic effects is anticipated from their use owing these...
PMC3942204
core_pubmed_pmc
Simple and Sensitive Analysis of Blonanserin and Blonanserin C in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry and Its Application
Simple and Sensitive Analysis of Blonanserin and Blonanserin C in Human Plasma by Liquid Chromatography Tandem Mass Spectrometry and Its Application Abstract Abstract A highly sensitive, simple, and rapid liquid chromatography tandem mass spectrometry method to simultaneously determine blonanserin and blonanserin C in ...
PMC7648590
core_pubmed_pmc
Dose escalation of osimertinib for intracranial progression in EGFR mutated non-small-cell lung cancer with brain metastases
Dose escalation of osimertinib for intracranial progression in EGFR mutated non-small-cell lung cancer with brain metastases Abstract Abstract Background Osimertinib is a selective irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with increased penetration across the blood–brain barrie...
PMC10988998
core_pubmed_pmc
A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness
A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness Abstract ABSTRACT The objective of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of VIR...
PMC3563392
core_pubmed_pmc
Effect of High-Dose or Split-Dose Artesunate on Parasite Clearance in Artemisinin-Resistant Falciparum Malaria
Effect of High-Dose or Split-Dose Artesunate on Parasite Clearance in Artemisinin-Resistant Falciparum Malaria Abstract New treatment strategies are needed for artemisinin-resistant falciparum malaria. This randomized trial shows that neither increasing nor splitting the standard once-daily artesunate dose reverses the...
PMC7163385
core_pubmed_pmc
Early antituberculosis drug exposure in hospitalized patients with human immunodeficiency virus‐associated tuberculosis
Early antituberculosis drug exposure in hospitalized patients with human immunodeficiency virus‐associated tuberculosis Abstract Abstract Aims Patients hospitalized at the time of human immunodeficiency virus‐associated tuberculosis (HIV‐TB) diagnosis have high early mortality. We hypothesized that compared to outpatie...
PMC11033591
core_pubmed_pmc
Emicizumab prophylaxis in infants with hemophilia A (HAVEN 7): primary analysis of a phase 3b open-label trial
Emicizumab prophylaxis in infants with hemophilia A (HAVEN 7): primary analysis of a phase 3b open-label trial Abstract Key Points • Subcutaneous emicizumab administered from birth has the potential to reduce the risk of ICH and joint bleeds before damage occurs. • Primary analysis of the HAVEN 7 trial indicates emiciz...
PMC8343024
core_pubmed_pmc
Mechanistic Modeling of a Novel Oncolytic Virus, V937, to Describe Viral Kinetic and Dynamic Processes Following Intratumoral and Intravenous Administration
Mechanistic Modeling of a Novel Oncolytic Virus, V937, to Describe Viral Kinetic and Dynamic Processes Following Intratumoral and Intravenous Administration Abstract Abstract V937 is an investigational novel oncolytic non-genetically modified Kuykendall strain of Coxsackievirus A21 which is in clinical development for ...
PMC10627225
core_pubmed_pmc
A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti–PD-1 mAb, in patients with advanced or metastatic solid tumors
A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti–PD-1 mAb, in patients with advanced or metastatic solid tumors Abstract Background QL1604 is a humanized immunoglobul...
PMC9328651
core_pubmed_pmc
Risperidone plasma concentrations are associated with side effects and effectiveness in children and adolescents with autism spectrum disorder
Risperidone plasma concentrations are associated with side effects and effectiveness in children and adolescents with autism spectrum disorder Abstract Aim Risperidone is the most commonly prescribed antipsychotic drug to children and adolescents worldwide, but it is associated with serious side effects, including weig...
PMC3123694
core_pubmed_pmc
Pharmacokinetic results of a phase I trial of sorafenib in combination with dacarbazine in patients with advanced solid tumors
Pharmacokinetic results of a phase I trial of sorafenib in combination with dacarbazine in patients with advanced solid tumors Abstract Abstract Purpose Sorafenib, a multikinase inhibitor of Raf and several growth factor receptors, is under investigation in combination with dacarbazine, a commonly used chemotherapeutic...
PMC11364639
core_pubmed_pmc
Antimigraine activity of Asarinin by OPRM1 pathway with multifaceted impacts through network analysis
Antimigraine activity of Asarinin by OPRM1 pathway with multifaceted impacts through network analysis Abstract Migraine is a debilitating neurological disorder impacting millions worldwide. Calcitonin Gene-Related Peptide (CGRP) has emerged as a key player in migraine pathophysiology, leading to the development of targ...
PMC12508063
core_pubmed_pmc
Chloroindazole based estrogen receptor β ligands with favorable pharmacokinetics promote functional remyelination and visual recovery
Chloroindazole based estrogen receptor β ligands with favorable pharmacokinetics promote functional remyelination and visual recovery Abstract Abstract Multiple sclerosis (MS) is a chronic autoimmune, demyelinating, and neurodegenerative disease that results in motor, visual, and cognitive deficits. While existing trea...
PMC3625417
core_pubmed_pmc
Investigation of herb-drug interactions with ginkgo biloba in women receiving hormonal treatment for early breast cancer
Investigation of herb-drug interactions with ginkgo biloba in women receiving hormonal treatment for early breast cancer Abstract Abstract Women receiving treatment for breast cancer commonly ingest herbal medicines. Little is known about the potential for herb-drug interactions in this population. The aim of this stud...
PMC12745456
core_pubmed_pmc
Optimization of hemophilia B treatment via population PK modeling of rIX-FP, including a 3-week regimen
Optimization of hemophilia B treatment via population PK modeling of rIX-FP, including a 3-week regimen Abstract Background Recombinant factor IX–albumin fusion protein (rIX-FP) enables extended-interval prophylaxis for hemophilia B. While higher trough levels with reduced dosing frequency have been shown vs. standard ...
PMC5751197
core_pubmed_pmc
Whole Body and CNS Biodistribution of rhHNS in Cynomolgus Monkeys after Intrathecal Lumbar Administration: Treatment Implications for Patients with MPS IIIA
Whole Body and CNS Biodistribution of rhHNS in Cynomolgus Monkeys after Intrathecal Lumbar Administration: Treatment Implications for Patients with MPS IIIA Abstract Mucopolysaccharidosis III type A (MPS IIIA; Sanfilippo syndrome), a genetic lysosomal disorder causing a deficiency of heparan N -sulfatase (HNS), leads t...
PMC8451784
core_pubmed_pmc
Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease
Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease Abstract Abstract Background and Aim E6011 is a humanized monoclonal antibody targeting fractalkine (FKN), a CX3C chemokine, which regulates leukocyte trafficking during inflammation. We evaluated the safety an...
PMC12706396
core_pubmed_pmc
Model‐Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation
Model‐Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation Abstract ABSTRACT A subcutaneous formulation of nivolumab was evaluated in the phase III study CheckMate 67T ( NCT04810078 ). The co‐primary pharmacokinetic exposure endpoints,...
PMC12072228
core_pubmed_pmc
SpatialCNS ‐ PBPK : An R/Shiny Web‐Based Application for Physiologically Based Pharmacokinetic Modeling of Spatial Pharmacokinetics in the Human Central Nervous System and Brain Tumors
SpatialCNS ‐ PBPK : An R/Shiny Web‐Based Application for Physiologically Based Pharmacokinetic Modeling of Spatial Pharmacokinetics in the Human Central Nervous System and Brain Tumors Abstract ABSTRACT Quantitative understanding of drug penetration and exposure in the human central nervous system (CNS) and brain tumor...
PMC10740680
core_pubmed_pmc
Impact of Beta-Lactam Target Attainment on Resistance Development in Patients with Gram-Negative Infections
Impact of Beta-Lactam Target Attainment on Resistance Development in Patients with Gram-Negative Infections Abstract Background: The objective was to identify associations between beta-lactam pharmacokinetic/pharmacodynamic (PK/PD) targets and Gram-negative bacteria resistance emergence in patients. Methods: Retrospect...
PMC11795524
core_pubmed_pmc
Melanin-Binding-Based Discovery of Topically Instilled Carbonic Anhydrase Inhibitors for Targeted Delivery and Prolonged Action in the Eye
Melanin-Binding-Based Discovery of Topically Instilled Carbonic Anhydrase Inhibitors for Targeted Delivery and Prolonged Action in the Eye Abstract Glaucoma is a vision-threatening disease that is currently treated with intraocular-pressure-reducing eyedrops that are instilled once or multiple times daily. Unfortunatel...
PMC8592512
core_pubmed_pmc
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary Modeling PBPK 360: THE STATE OF THE SCIENCE The plenary session highlighted current scientific knowledge and gaps from key stakeholders in the PBPK field. Provid...
PMC11043521
core_pubmed_pmc
Use of quantitative in vitro to in vivo extrapolation (QIVIVE) for the assessment of non-combustible next-generation product aerosols
Use of quantitative in vitro to in vivo extrapolation (QIVIVE) for the assessment of non-combustible next-generation product aerosols Abstract Abstract With the use of in vitro new approach methodologies (NAMs) for the assessment of non-combustible next-generation nicotine delivery products, new extrapolation methods w...
PMC4562161
core_pubmed_pmc
Population Pharmacokinetic Model Characterizing 24-Hour Variation in the Pharmacokinetics of Oral and Intravenous Midazolam in Healthy Volunteers
Population Pharmacokinetic Model Characterizing 24-Hour Variation in the Pharmacokinetics of Oral and Intravenous Midazolam in Healthy Volunteers Abstract Daily rhythms in physiology may affect the pharmacokinetics of a drug. The aim of this study was to evaluate 24-hour variation in the pharmacokinetics of the CYP3A s...
PMC7788723
core_pubmed_pmc
Pharmacokinetic profile of amodiaquine and its active metabolite desethylamodiaquine in Ghanaian patients with uncomplicated falciparum malaria
Pharmacokinetic profile of amodiaquine and its active metabolite desethylamodiaquine in Ghanaian patients with uncomplicated falciparum malaria Abstract Background Accurate measurement of anti-malarial drug concentrations in therapeutic efficacy studies is essential to distinguish between inadequate drug exposure and a...
PMC6070025
core_pubmed_pmc
Evaluation of the efficacy of rezafungin, a novel echinocandin, in the treatment of disseminated Candida auris infection using an immunocompromised mouse model
Evaluation of the efficacy of rezafungin, a novel echinocandin, in the treatment of disseminated Candida auris infection using an immunocompromised mouse model Abstract Abstract Background Multiple cases of Candida auris infection have been reported with high mortality rates owing to its MDR nature. Rezafungin (previou...
PMC8060346
core_pubmed_pmc
Development and evaluation of physiologically based pharmacokinetic drug-disease models for predicting captopril pharmacokinetics in chronic diseases
Development and evaluation of physiologically based pharmacokinetic drug-disease models for predicting captopril pharmacokinetics in chronic diseases Abstract The advancement in the processing speeds of computing machines has facilitated the development of complex physiologically based pharmacokinetic (PBPK) models. Th...
PMC11283281
core_pubmed_pmc
Translational pharmacokinetic/pharmacodynamic model for mRNA‐0184, an investigational therapeutic for the treatment of heart failure
Translational pharmacokinetic/pharmacodynamic model for mRNA‐0184, an investigational therapeutic for the treatment of heart failure Abstract Abstract Heart failure (HF) is a complex, progressive disorder that is associated with substantial morbidity and mortality on a global scale. Relaxin‐2 is a naturally occurring h...
PMC5680187
core_pubmed_pmc
Assessing the impact of imperfect adherence to artemether-lumefantrine on malaria treatment outcomes using within-host modelling
Assessing the impact of imperfect adherence to artemether-lumefantrine on malaria treatment outcomes using within-host modelling Abstract Artemether-lumefantrine (AL) is the most widely-recommended treatment for uncomplicated Plasmodium falciparum malaria worldwide. Its safety and efficacy have been extensively demonst...
PMC11010373
core_pubmed_pmc
The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm b...
The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm b...
PMC6298132
core_pubmed_pmc
A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects
A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects Abstract Objective: Phase I, open-label, randomized, single-dose, 3-period crossover stu...
PMC10026330
core_pubmed_pmc
Bioassay for total serum bioactivity of Atractylodes lancea
Bioassay for total serum bioactivity of Atractylodes lancea Abstract Abstract The study aimed to establish a bioassay for total bioactivity of Atractylodes lancea (AL) in human serum samples. Inhibition of bacterial growth ( Staphylococcus aureus ATCC 25923) was assessed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenylt...
PMC12087691
core_pubmed_pmc
Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo Pre‐Administration in a Randomized, Double‐Blind, Cross‐Over Phase I Trial
Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo Pre‐Administration in a Randomized, Double‐Blind, Cross‐Over Phase I Trial Abstract Abstract Psychedelics, such as psilocybin and lysergic acid diethylamide (LSD), are being investigated for the treatment of depressive and anxiety disorders, for whic...
PMC3380185
core_pubmed_pmc
UGT2B17 Genetic Polymorphisms Dramatically Affect the Pharmacokinetics of MK-7246 in Healthy Subjects in a First-in-Human Study
UGT2B17 Genetic Polymorphisms Dramatically Affect the Pharmacokinetics of MK-7246 in Healthy Subjects in a First-in-Human Study Abstract MK-7246, an antagonist of the chemoattractant receptor on T helper type 2 (Th2) cells, is being developed for the treatment of respiratory diseases. In a first-in-human study, we inve...
PMC7133737
core_pubmed_pmc
Predictive modeling of aspirin‐triggered resolvin D1 pharmacokinetics for the study of Sjögren's syndrome
Predictive modeling of aspirin‐triggered resolvin D1 pharmacokinetics for the study of Sjögren's syndrome Abstract Abstract Objectives Sjögren's syndrome (SS) is an autoimmune disease that causes chronic inflammation of the salivary glands leading to secretory dysfunction. Previous studies demonstrated that aspirin‐tri...
PMC5604555
core_pubmed_pmc
Variability of the drug response to nonsteroidal anti-inflammatory drugs according to cyclooxygenase-2 genetic polymorphism
Variability of the drug response to nonsteroidal anti-inflammatory drugs according to cyclooxygenase-2 genetic polymorphism Abstract Abstract Purpose Cyclooxygenase (COX) is the main pharmacodynamic target of nonsteroidal anti-inflammatory drugs (NSAIDs). We investigated the inhibitory effects on COX-2 after NSAIDs adm...
PMC7504801
core_pubmed_pmc
Evaluation of the Percutaneous Absorption of Drug Molecules in Zebrafish
Evaluation of the Percutaneous Absorption of Drug Molecules in Zebrafish Abstract In recent decades, zebrafish ( Danio rerio ) has become a widely used vertebrate animal model for studying development and human diseases. However, studies on skin medication using zebrafish are rare. Here, we developed a novel protocol f...
PMC12350568
core_pubmed_pmc
Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing
Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing Abstract Abstract Males and females are known to exhibit significant differences in drug pharmacokinetics and pharmacodynamics, which are still overlooked in pharmaceutical research and development. These disparities contribute to a...
PMC7969430
core_pubmed_pmc
Population Pharmacokinetic Analysis of Pexidartinib in Healthy Subjects and Patients With Tenosynovial Giant Cell Tumor or Other Solid Tumors
Population Pharmacokinetic Analysis of Pexidartinib in Healthy Subjects and Patients With Tenosynovial Giant Cell Tumor or Other Solid Tumors Abstract Abstract Pexidartinib is a kinase inhibitor that induces tumor response and improvements in symptoms and functional outcomes in adult patients with symptomatic tenosynov...
PMC10571248
core_pubmed_pmc
Dermal effects and pharmacokinetic evaluation of the lidocaine/prilocaine cream in healthy Chinese volunteers
Dermal effects and pharmacokinetic evaluation of the lidocaine/prilocaine cream in healthy Chinese volunteers Abstract Background EMLA cream is a local anesthetic. The pharmacokinetics and dermal effects of a topical anesthetic formulation has not been evaluated in healthy Chinese volunteers. Materials and methods The ...
PMC10993868
core_pubmed_pmc
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities Abstract Bioequivalence (BE) studies are considered the standard for demonstrating that the per...
PMC4576090
core_pubmed_pmc
Lumefantrine and Desbutyl-Lumefantrine Population Pharmacokinetic-Pharmacodynamic Relationships in Pregnant Women with Uncomplicated Plasmodium falciparum Malaria on the Thailand-Myanmar Border
Lumefantrine and Desbutyl-Lumefantrine Population Pharmacokinetic-Pharmacodynamic Relationships in Pregnant Women with Uncomplicated Plasmodium falciparum Malaria on the Thailand-Myanmar Border Abstract Artemether-lumefantrine is the most widely used antimalarial artemisinin-based combination treatment. Recent studies ...
PMC4011164
core_pubmed_pmc
Powers of the Likelihood Ratio Test and the Correlation Test Using Empirical Bayes Estimates for Various Shrinkages in Population Pharmacokinetics
Powers of the Likelihood Ratio Test and the Correlation Test Using Empirical Bayes Estimates for Various Shrinkages in Population Pharmacokinetics Abstract We compared the powers of the likelihood ratio test (LRT) and the Pearson correlation test (CT) from empirical Bayes estimates (EBEs) for various designs and shrink...
PMC9467902
core_pubmed_pmc
Abdominal tissue concentrations and penetration of carboplatin in a HIPEC procedure ‒ assessment in a novel porcine model
Abdominal tissue concentrations and penetration of carboplatin in a HIPEC procedure ‒ assessment in a novel porcine model Abstract Abstract Objectives Peritoneal dissemination from intraabdominal cancers is associated with poor prognosis and rapid disease progression. Hyperthermic intraperitoneal chemotherapy (HIPEC) i...
PMC8615263
core_pubmed_pmc
The Inhibitory Activity of Curcumin on P-Glycoprotein and Its Uptake by and Efflux from LS180 Cells Is Not Affected by Its Galenic Formulation
The Inhibitory Activity of Curcumin on P-Glycoprotein and Its Uptake by and Efflux from LS180 Cells Is Not Affected by Its Galenic Formulation Abstract Abstract The biological activities of curcumin in humans, including its antioxidative and anti-inflammatory functions, are limited by its naturally low bioavailability....
PMC12833316
core_pubmed_pmc
Combining exercise and nanoparticle-based therapies: a review of physiological synergies and pharmacological potential
Combining exercise and nanoparticle-based therapies: a review of physiological synergies and pharmacological potential Abstract Abstract The convergence of nanotechnology and exercise science represents a novel pharmacological approach to enhance therapeutic efficacy, physiological resilience, and performance outcomes....
PMC9509535
core_pubmed_pmc
Combined Risk Assessment of Food-derived Coumarin with in Silico Approaches
Combined Risk Assessment of Food-derived Coumarin with in Silico Approaches Abstract Abstract Hepatotoxicity associated with food-derived coumarin occurs occasionally in humans. We have, herein, assessed the data of existing clinical and nonclinical studies as well as those of in silico models for humans in order to sh...
PMC10583242
core_pubmed_pmc
Improving pharmacometrics analysis efficiency using DataCheQC : An interactive, Shiny‐based app for quality control of pharmacometrics datasets
Improving pharmacometrics analysis efficiency using DataCheQC : An interactive, Shiny‐based app for quality control of pharmacometrics datasets Abstract Abstract DataCheQC is an interactive application based on the R Shiny framework developed for the purposes of performing quality control (QC) checks on pharmacometric ...
PMC6398880
core_pubmed_pmc
Pharmacologic characterization of fluzoparib, a novel poly( ADP ‐ribose) polymerase inhibitor undergoing clinical trials
Pharmacologic characterization of fluzoparib, a novel poly( ADP ‐ribose) polymerase inhibitor undergoing clinical trials Abstract Poly( ADP ‐ribose) polymerase ( PARP ) enzymes play an important role in repairing DNA damage and maintaining genomic stability. Olaparib, the first‐in‐class PARP inhibitor, has shown remark...
PMC6853145
core_pubmed_pmc
A Physiologically‐Based Pharmacokinetic Model for Targeting Calcitriol‐Conjugated Quantum Dots to Inflammatory Breast Cancer Cells
A Physiologically‐Based Pharmacokinetic Model for Targeting Calcitriol‐Conjugated Quantum Dots to Inflammatory Breast Cancer Cells Abstract Abstract Quantum dots (QDs) conjugated with 1,25 dihydroxyvitamin D3 (calcitriol) and Mucin‐1 (MUC‐1) antibodies (SM3) have been found to target inflammatory breast cancer (IBC) tu...
PMC12913698
core_pubmed_pmc
A Randomized Phase 1 Study Comparing the PK , PD , Safety, and Immunogenicity of Proposed Biosimilar RGB ‐14‐X and Denosumab in Healthy Adult Males
A Randomized Phase 1 Study Comparing the PK , PD , Safety, and Immunogenicity of Proposed Biosimilar RGB ‐14‐X and Denosumab in Healthy Adult Males Abstract ABSTRACT Denosumab is a monoclonal antibody targeting the receptor activator of nuclear factor kappa‐b ligand widely used for the prevention of skeletal‐related ev...
PMC10215898
core_pubmed_pmc
Does Nitrofurantoin Improve the Portfolio of Vets against Resistant Bacteria in Companion Animals?
Does Nitrofurantoin Improve the Portfolio of Vets against Resistant Bacteria in Companion Animals? Abstract In clinical practice in dogs and cats, antimicrobials are frequently used, sometimes overused or misused, increasing antimicrobial resistance (AMR). In order to limit the phenomenon, laws have been enacted and gu...
PMC3900310
core_pubmed_pmc
Selective ROCK2 inhibition in focal cerebral ischemia
Selective ROCK2 inhibition in focal cerebral ischemia Abstract Objective Rho-associated kinase (ROCK) is a key regulator of numerous processes in multiple cell types relevant in stroke pathophysiology. ROCK inhibitors have improved outcome in experimental models of acute ischemic or hemorrhagic stroke. However, the rel...
PMC4346016
core_pubmed_pmc
Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers
Pharmacokinetic interaction between udenafil and dapoxetine: a randomized, open-labeled crossover study in healthy male volunteers Abstract Abstract Background “Udenafil” is a phosphodiesterase-5 inhibitor indicated for erectile dysfunction. “Dapoxetine” is a serotonin transport inhibitor indicated for premature ejacul...
PMC10017969
core_pubmed_pmc
Pharmacokinetic study of Strongylocentrotus nudus egg polysaccharide in rats and beagles using a 3 H-labeling method
Pharmacokinetic study of Strongylocentrotus nudus egg polysaccharide in rats and beagles using a 3 H-labeling method Abstract Strongylocentrotus nudus egg polysaccharide (SEP) extracted from sea urchins has potential anticancer activity. However, little is known about its pharmacokinetic properties. To investigate the ...
PMC10515590
core_pubmed_pmc
Mechanosynthesis of Stable Salt Hydrates of Allopurinol with Enhanced Dissolution, Diffusion, and Pharmacokinetics
Mechanosynthesis of Stable Salt Hydrates of Allopurinol with Enhanced Dissolution, Diffusion, and Pharmacokinetics Abstract Allopurinol (ALO) is a medication that treats gout and kidney stones by lowering uric acid synthesis in the blood. The biopharmaceutics classification system (BCS) IV drug exhibits poor aqueous so...
PMC10362793
core_pubmed_pmc
Screening and molecular dynamics simulation of compounds inhibiting MurB enzyme of drug-resistant Mycobacterium tuberculosis : An in-silico approach
Screening and molecular dynamics simulation of compounds inhibiting MurB enzyme of drug-resistant Mycobacterium tuberculosis : An in-silico approach Abstract Mycobacterium tuberculosis (MTB) is becoming more and more resistant to drugs and it is a common problem, making current antimicrobials ineffective and highlighti...
PMC9904858
core_pubmed_pmc
In silico study of novel niclosamide derivatives, SARS-CoV-2 nonstructural proteins catalytic residue-targeting small molecules drug candidates
In silico study of novel niclosamide derivatives, SARS-CoV-2 nonstructural proteins catalytic residue-targeting small molecules drug candidates Abstract The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-mediated coronavirus disease 2019 (COVID-19) infection remains a global pandemic and health emergency ...
PMC3005114
core_pubmed_pmc
Clearance (née Rowland) concepts: a downdate and an update
Clearance (née Rowland) concepts: a downdate and an update Abstract Abstract A number of experimental observations in the late 1960s, early 1970s could not be explained by the pharmacokinetic theory available at that time. For example rats receiving phenobarbital as an enzyme inducing agent exhibited increased eliminat...
PMC12653432
core_pubmed_pmc
The Three Musketeers in Cancer Therapy: Pharmacokinetics, Pharmacodynamics and Personalised Approach
The Three Musketeers in Cancer Therapy: Pharmacokinetics, Pharmacodynamics and Personalised Approach Abstract Abstract Cancer therapy is rapidly evolving from a one-size-fits-all paradigm toward highly personalized approaches. Traditional chemotherapies and radiotherapies, while broadly applied, often yield suboptimal ...
PMC6334401
core_pubmed_pmc
Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial Abstract Abstract Background Gabapentin has shown efficacy i...