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PMC10767306 | core_pubmed_pmc | Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma | Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma Abstract Abstract Purpose: Effective treatment of locally advanced or metastatic urothelial carcinoma (mUC) remains an unmet need. Antibody–drug conjugates (ADC) providing targeted dru... |
PMC10892084 | core_pubmed_pmc | Quantitative Analysis of Cenobamate and Concomitant Anti-Seizure Medications in Human Plasma via Ultra-High Performance Liquid Chromatography–Tandem Mass Spectrometry | Quantitative Analysis of Cenobamate and Concomitant Anti-Seizure Medications in Human Plasma via Ultra-High Performance Liquid Chromatography–Tandem Mass Spectrometry Abstract Abstract Cenobamate (CNB) is a new anti-seizure medication (ASM) recently introduced in clinical practice after approval by the FDA and EMA for ... |
PMC3118685 | core_pubmed_pmc | Study of pharmacokinetics and tissue distribution of liposomal brucine for dermal administration | Study of pharmacokinetics and tissue distribution of liposomal brucine for dermal administration Abstract Objective: To evaluate the pharmacokinetics and tissue distribution of liposomal brucine (LB) for dermal application. Methods: Pharmacokinetics and tissue distribution were studied by in vivo animal testing. High p... |
PMC12707326 | core_pubmed_pmc | Overcoming Antimicrobial Resistance in Bacterial Keratitis With an Antibiotic-Eluting Contact Lens | Overcoming Antimicrobial Resistance in Bacterial Keratitis With an Antibiotic-Eluting Contact Lens Abstract Abstract Purpose Bacterial keratitis (BK) is a leading cause of corneal blindness globally, with an alarming rise in resistant infections. Current standard-of-care antibiotic eye drops or ointments suffer from lo... |
PMC7415440 | core_pubmed_pmc | First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of a Neuroprotective Poly (ADP‐ribose) Polymerase‐1 Inhibitor, JPI-289, in Healthy Volunteers | First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of a Neuroprotective Poly (ADP‐ribose) Polymerase‐1 Inhibitor, JPI-289, in Healthy Volunteers Abstract Background Poly (ADP-ribose) polymerase-1 (PARP-1) inhibitor has therapeutic potential for acute ischemic stroke by suppressing microglial ac... |
PMC12909361 | core_pubmed_pmc | A physics-informed neural network approach for estimating population-level pharmacokinetic parameters from aggregated concentration data | A physics-informed neural network approach for estimating population-level pharmacokinetic parameters from aggregated concentration data Abstract The pharmacokinetic literature is rich in aggregated concentration data that contain valuable information, yet tools to extract this information remain limited. This work int... |
PMC11695783 | core_pubmed_pmc | The novel pleuromutilin derivative 22–((4-((4-nitrophenyl)acetamido)phenyl)thio)deoxy pleuromutilin possesses robust anti-mycoplasma activity both in vitro and in vivo | The novel pleuromutilin derivative 22–((4-((4-nitrophenyl)acetamido)phenyl)thio)deoxy pleuromutilin possesses robust anti-mycoplasma activity both in vitro and in vivo Abstract Objective Mycoplasmas are structurally simple pathogenic microorganisms that can cause a wide range of diseases in humans and animals and conve... |
PMC7383777 | core_pubmed_pmc | The association between anti‐insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast‐acting insulin aspart in children and adolescents with type 1 diabetes | The association between anti‐insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast‐acting insulin aspart in children and adolescents with type 1 diabetes Abstract Abstract Background Fast‐acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) ensuri... |
PMC5955748 | core_pubmed_pmc | Investigation of the synergistic effects of haloperidol combined with Calculus Bovis Sativus in treating MK-801-induced schizophrenia in rats | Investigation of the synergistic effects of haloperidol combined with Calculus Bovis Sativus in treating MK-801-induced schizophrenia in rats Abstract Abstract Clinical studies that focused on treating schizophrenia showed that Calculus Bovis Sativus (CBS), a substitute of Calculus Bovis , when used in combination with... |
PMC3425428 | core_pubmed_pmc | Why Do SGLT2 Inhibitors Inhibit Only 30–50% of Renal Glucose Reabsorption in Humans? | Why Do SGLT2 Inhibitors Inhibit Only 30–50% of Renal Glucose Reabsorption in Humans? Abstract Abstract Sodium glucose cotransporter 2 (SGLT2) inhibition is a novel and promising treatment for diabetes under late-stage clinical development. It generally is accepted that SGLT2 mediates 90% of renal glucose reabsorption. ... |
PMC3861587 | core_pubmed_pmc | Icotinib combined with rapamycin in a renal transplant recipient with epidermal growth factor receptor-mutated non-small cell lung cancer: A case report | Icotinib combined with rapamycin in a renal transplant recipient with epidermal growth factor receptor-mutated non-small cell lung cancer: A case report Abstract As kidney transplant recipients are at increased risk of developing cancer, regular monitoring should be undertaken to monitor the balance between immunosuppr... |
PMC11570312 | core_pubmed_pmc | Development, optimization, and characterization of polymeric micelles to improve dasatinib oral bioavailability: Hep G2 cell cytotoxicity and in vivo pharmacokinetics for targeted liver cancer therapy | Development, optimization, and characterization of polymeric micelles to improve dasatinib oral bioavailability: Hep G2 cell cytotoxicity and in vivo pharmacokinetics for targeted liver cancer therapy Abstract The efficacy of dasatinib (DAS) in treating hepatocellular carcinoma (HCC) is hindered by its poor bioavailabi... |
PMC12202194 | core_pubmed_pmc | Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time‐To‐Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A | Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time‐To‐Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A Abstract Abstract Efanesoctocog alfa is a first‐in‐class high‐sustained factor VIII (HSF) replacement therapy for treatment of hemophilia A. This article presents po... |
PMC10647616 | core_pubmed_pmc | Side-Chain Modified [ 99m Tc]Tc-DT1 Mimics: A Comparative Study in NTS 1 R-Positive Models | Side-Chain Modified [ 99m Tc]Tc-DT1 Mimics: A Comparative Study in NTS 1 R-Positive Models Abstract Radiolabeled neurotensin analogs have been developed as candidates for theranostic use against neurotensin subtype 1 receptor (NTS 1 R)-expressing cancer. However, their fast degradation by two major peptidases, neprilys... |
PMC5989019 | core_pubmed_pmc | Effects of leucovorin (folinic acid) in the methotrexate-treated rat brain | Effects of leucovorin (folinic acid) in the methotrexate-treated rat brain Abstract Folinic acid (FA) is generally administered to patients with CNS tumors in order to treat severe neurological disorders caused by methotrexate (MTX); therefore, we herein examined the effects of the co-administration of FA on MTX concen... |
PMC10044979 | core_pubmed_pmc | Immunosuppressive Therapy of Biopsy-Proven, Virus-Negative, Autoimmune/Immune-Mediated Myocarditis—Focus on Azathioprine: A Review of Existing Evidence and Future Perspectives | Immunosuppressive Therapy of Biopsy-Proven, Virus-Negative, Autoimmune/Immune-Mediated Myocarditis—Focus on Azathioprine: A Review of Existing Evidence and Future Perspectives Abstract Abstract Simple Summary Myocarditis is one of the leading causes of acute and chronic heart failure, adverse ventricular remodelling, a... |
PMC8960278 | core_pubmed_pmc | Characterizing Pharmacokinetics in Children With Obesity—Physiological, Drug, Patient, and Methodological Considerations | Characterizing Pharmacokinetics in Children With Obesity—Physiological, Drug, Patient, and Methodological Considerations Abstract Childhood obesity is an alarming public health problem. The pediatric obesity rate has quadrupled in the past 30 years, and currently nearly 20% of United States children and 9% of children ... |
PMC7555481 | core_pubmed_pmc | Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats | Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats Abstract Ivermectin is a widely used antiparasitic drug with known efficacy against several single-strain RNA viruses. Recent data shows significant reduction of SARS-CoV-2 replication in vitro by ivermectin... |
PMC4992876 | core_pubmed_pmc | Monitoring Tumor Hypoxia Using 18 F-FMISO PET and Pharmacokinetics Modeling after Photodynamic Therapy | Monitoring Tumor Hypoxia Using 18 F-FMISO PET and Pharmacokinetics Modeling after Photodynamic Therapy Abstract Photodynamic therapy (PDT) is an efficacious treatment for some types of cancers. However, PDT-induced tumor hypoxia as a result of oxygen consumption and vascular damage can reduce the efficacy of this thera... |
PMC4130380 | core_pubmed_pmc | The pyrazinamide susceptibility breakpoint above which combination therapy fails | The pyrazinamide susceptibility breakpoint above which combination therapy fails Abstract Objectives To identify the pyrazinamide MIC above which standard combination therapy fails. Methods MICs of pyrazinamide were determined for Mycobacterium tuberculosis isolates, cultured from 58 patients in a previous randomized c... |
PMC6590207 | core_pubmed_pmc | Influence of Renal Function on Evolocumab Exposure, Pharmacodynamics, and Safety | Influence of Renal Function on Evolocumab Exposure, Pharmacodynamics, and Safety Abstract Abstract We evaluated the pharmacokinetics, pharmacodynamics, and safety of evolocumab, a fully human monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), in an open‐label, parallel‐design study in pa... |
PMC12415810 | core_pubmed_pmc | Pharmacokinetics of Amoxicillin in the Cat | Pharmacokinetics of Amoxicillin in the Cat Abstract ABSTRACT The pharmacokinetics and plasma protein binding of amoxicillin in cats has not been thoroughly investigated. In a single‐group sequential designed experimental study, amoxicillin was administered to six healthy cats intravenously, orally, and subcutaneously. ... |
PMC12568254 | core_pubmed_pmc | Absorption and Tissue Distribution of Environmental Pollutant HFPO-DA, and Its Effect on Hepatic Lipid Metabolism Reprogramming in Mice | Absorption and Tissue Distribution of Environmental Pollutant HFPO-DA, and Its Effect on Hepatic Lipid Metabolism Reprogramming in Mice Abstract Objective: Hexafluoropropylene oxide dimer acid (HFPO-DA), also known as GenX, is widely used globally, raising concerns about its safety and public health implications. Howev... |
PMC12952630 | core_pubmed_pmc | Cheminformatics-driven discovery of natural isoquinoline alkaloid inhibitors of Beta-secretase I for Alzheimer’s management | Cheminformatics-driven discovery of natural isoquinoline alkaloid inhibitors of Beta-secretase I for Alzheimer’s management Abstract Abstract Alzheimer’s disease (AD) is characterized by the gradual deterioration of cognitive functions, speech impairment, and memory loss. It can potentially be treated by targeting the ... |
PMC5106233 | core_pubmed_pmc | Treatment-resistant schizophrenia: current insights on the pharmacogenomics of antipsychotics | Treatment-resistant schizophrenia: current insights on the pharmacogenomics of antipsychotics Abstract Abstract Up to 30% of people with schizophrenia do not respond to two (or more) trials of dopaminergic antipsychotics. They are said to have treatment-resistant schizophrenia (TRS). Clozapine is still the only effecti... |
PMC7004103 | core_pubmed_pmc | Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection | Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection Abstract Currently, the only approved hepatitis C virus (HCV) treatment for children aged <12 years is pegylated interferon plus ribavirin. In an open‐label study, we evaluated the safety and efficacy of s... |
PMC12159082 | core_pubmed_pmc | Leveraging Model Master Files for Long-Acting Injectables | Leveraging Model Master Files for Long-Acting Injectables Abstract Abstract The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a public workshop on May 2–3, 2024, titled “Considerations and Potential Regulatory Applications for a Model Master File”. The workshop ai... |
PMC8565507 | core_pubmed_pmc | Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan | Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan Abstract Supplemental Digital Content is available in the text. OBJECTIVES: To demonstrate the efficacy, safety, and pharmacokinetics of dexmedeto... |
PMC10622740 | core_pubmed_pmc | Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab | Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab Abstract Abstract Aim The aim of this study was to add robustness and provide further evidence on the bioequivalence, safety and immunogenicity between MB02 and reference bevacizumab. No similar study has been performed... |
PMC8538675 | core_pubmed_pmc | Nutraceuticals for Peripheral Vestibular Pathology: Properties, Usefulness, Future Perspectives and Medico-Legal Aspects | Nutraceuticals for Peripheral Vestibular Pathology: Properties, Usefulness, Future Perspectives and Medico-Legal Aspects Abstract Abstract Vestibular disorders may generate complex signs and symptoms, which may alter patients’ balance and the quality of life. Dizziness and vertigo can strongly affect daily activities a... |
PMC8813803 | core_pubmed_pmc | Physiologically Based Pharmacokinetic Modelling of Inhaled Nemiralisib: Mechanistic Components for Pulmonary Absorption, Systemic Distribution, and Oral Absorption | Physiologically Based Pharmacokinetic Modelling of Inhaled Nemiralisib: Mechanistic Components for Pulmonary Absorption, Systemic Distribution, and Oral Absorption Abstract Background and Objectives Physiologically based pharmacokinetic (PBPK) modelling has evolved to accommodate different routes of drug administration... |
PMC7225193 | core_pubmed_pmc | An Integrated Dialysis Pharmacometric (IDP) Model to Evaluate the Pharmacokinetics in Patients Undergoing Renal Replacement Therapy | An Integrated Dialysis Pharmacometric (IDP) Model to Evaluate the Pharmacokinetics in Patients Undergoing Renal Replacement Therapy Abstract Purpose Clearance via renal replacement therapy (RRT) can significantly alter the pharmacokinetic profile of drugs. The aim of this study was (i) to improve the use of clinical tr... |
PMC10666227 | core_pubmed_pmc | Assessment of Novel Mesothelin-Specific Human Antibody Domain VH-Fc Fusion Proteins-Based PET Agents | Assessment of Novel Mesothelin-Specific Human Antibody Domain VH-Fc Fusion Proteins-Based PET Agents Abstract Mesothelin (MSLN) is a tumor-associated antigen found in a variety of cancers and is a target for imaging and therapeutic applications in MSLN-expressing tumors. We have developed high affinity anti-MSLN human ... |
PMC4123858 | core_pubmed_pmc | A pilot study of leukocyte expression patterns for drug metabolizing enzyme and transporter transcripts in autoimmune glomerulonephritis | A pilot study of leukocyte expression patterns for drug metabolizing enzyme and transporter transcripts in autoimmune glomerulonephritis Abstract Objective: Leukocyte mRNA expression patterns of drug metabolizing enzyme genes and transporter genes that are relevant for the disposition of cyclophosphamide and mycophenol... |
PMC12552610 | core_pubmed_pmc | Development of [ 18 F]ACI-19626 as a first-in-class brain PET tracer for imaging TDP-43 pathology | Development of [ 18 F]ACI-19626 as a first-in-class brain PET tracer for imaging TDP-43 pathology Abstract Aggregated TDP-43 is a hallmark of frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and limbic-predominant age-related TDP-43 encephalopathy (LATE), and a common co-pathology in other neurodegen... |
PMC5038276 | core_pubmed_pmc | Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients | Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients Abstract Abstract This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients... |
PMC4675922 | core_pubmed_pmc | Usefulness of serum cystatin C to determine the dose of vancomycin in neonate | Usefulness of serum cystatin C to determine the dose of vancomycin in neonate Abstract Abstract Purpose The vancomycin dosage regimen is regularly modified according to the patient's glomerular filtration rate (GFR). In the present study, we aimed to assess the usefulness of serum cystatin C (Cys-C) concentration, comp... |
PMC6262195 | core_pubmed_pmc | Pharmacokinetics of Glucocorticoid Replacement Before and After Bariatric Surgery in Patients With Adrenal Insufficiency | Pharmacokinetics of Glucocorticoid Replacement Before and After Bariatric Surgery in Patients With Adrenal Insufficiency Abstract Abstract Adequate glucocorticoid replacement in patients with primary or secondary adrenal insufficiency is essential to maintain general well-being. Little is known about the effects of bar... |
PMC5192970 | core_pubmed_pmc | Integrated Two‐Analyte Population Pharmacokinetic Model for Antibody–Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling | Integrated Two‐Analyte Population Pharmacokinetic Model for Antibody–Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling Abstract Abstract An integrated pharmacokinetics (PK) model that simultaneously describes concentrations of total antibody (Tab) and antibody‐conjugated monomethyl aurista... |
PMC6431368 | core_pubmed_pmc | Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia | Population Pharmacokinetics of Clozapine and Norclozapine and Switchability Assessment between Brands in Uruguayan Patients with Schizophrenia Abstract Clozapine (CZP) is an atypical antipsychotic agent commonly used in the treatment of schizophrenia. It is metabolized primarily by CYP1A2 enzyme, yielding a pharmacolog... |
PMC9828395 | core_pubmed_pmc | Physiologically‐Based Pharmacokinetic Model Development, Validation, and Application for Prediction of Eliglustat Drug–Drug Interactions | Physiologically‐Based Pharmacokinetic Model Development, Validation, and Application for Prediction of Eliglustat Drug–Drug Interactions Abstract Abstract Eliglustat is a glucosylceramide synthase inhibitor indicated as a long‐term substrate reduction therapy for adults with type 1 Gaucher disease, a lysosomal rare dis... |
PMC3651527 | core_pubmed_pmc | From evidence based medicine to mechanism based medicine. Reviewing the role of pharmacogenetics | From evidence based medicine to mechanism based medicine. Reviewing the role of pharmacogenetics Abstract Abstract Aim of the review The translation of evidence based medicine to a specific patient presents a considerable challenge. We present by means of the examples nortriptyline, tramadol, clopidogrel, coumarins, ab... |
PMC12164272 | core_pubmed_pmc | Ruthenium(II) Polypyridyl Complexes Containing COUBPY Ligands as Potent Photosensitizers for the Efficient Phototherapy of Hypoxic Tumors | Ruthenium(II) Polypyridyl Complexes Containing COUBPY Ligands as Potent Photosensitizers for the Efficient Phototherapy of Hypoxic Tumors Abstract Abstract Hypoxia, a hallmark of many solid tumors, is linked to increased cancer aggressiveness, metastasis, and resistance to conventional therapies, leading to poor patien... |
PMC7376292 | core_pubmed_pmc | Model‐Based Analysis Reveals a Sustained and Dose‐Dependent Acceleration of Wound Healing by VEGF‐A mRNA (AZD8601) | Model‐Based Analysis Reveals a Sustained and Dose‐Dependent Acceleration of Wound Healing by VEGF‐A mRNA (AZD8601) Abstract Intradermal delivery of AZD8601, an mRNA designed to produce vascular endothelial growth factor A (VEGF‐A), has previously been shown to accelerate cutaneous wound healing in a murine diabetic mod... |
PMC10446811 | core_pubmed_pmc | Gemcitabine enhances pharmacokinetic exposure of the major components of Danggui Buxue Decoction in rat via the promotion of intestinal permeability and down-regulation of CYP3A for combination treatment of non-small cell lung cancer | Gemcitabine enhances pharmacokinetic exposure of the major components of Danggui Buxue Decoction in rat via the promotion of intestinal permeability and down-regulation of CYP3A for combination treatment of non-small cell lung cancer Abstract Abstract Context Danggui Buxue Decoction (DBD), a traditional Chinese medicin... |
PMC7419005 | core_pubmed_pmc | Non-invasive monitoring of drug action: A new live in vitro assay design for Chagas’ disease drug discovery | Non-invasive monitoring of drug action: A new live in vitro assay design for Chagas’ disease drug discovery Abstract New assay designs are needed to improve the predictive value of the Trypanosoma cruzi in vitro tests used as part of the Chagas' disease drug development pipeline. Here, we employed a green fluorescent p... |
PMC4033946 | core_pubmed_pmc | Update on the Genetic Polymorphisms of Drug-Metabolizing Enzymes in Antiepileptic Drug Therapy | Update on the Genetic Polymorphisms of Drug-Metabolizing Enzymes in Antiepileptic Drug Therapy Abstract Genetic polymorphisms in the genes that encode drug-metabolizing enzymes are implicated in the inter-individual variability in the pharmacokinetics and pharmaco-dynamics of antiepileptic drugs (AEDs). However, the cl... |
PMC6157667 | core_pubmed_pmc | Population Pharmacokinetic/Pharmacodynamic Analysis of Nociceptive Pain Models Following an Oral Pregabalin Dose Administration to Healthy Subjects | Population Pharmacokinetic/Pharmacodynamic Analysis of Nociceptive Pain Models Following an Oral Pregabalin Dose Administration to Healthy Subjects Abstract Abstract A battery of pain models can be used in clinical trials to investigate the efficacy and to establish the concentration‐effect relationship of novel analge... |
PMC12521060 | core_pubmed_pmc | The Basel Modeling and Simulation Seminar: 20 Editions of Fostering Local Exchange in Pharmacometrics | The Basel Modeling and Simulation Seminar: 20 Editions of Fostering Local Exchange in Pharmacometrics Abstract ABSTRACT This year marks the 20th edition of the Basel Modeling and Simulation (M&S) Seminar, an initiative rooted in a commitment to promoting the exchange of the latest advancements in pharmacometrics and re... |
PMC12399714 | core_pubmed_pmc | Sex-related differences in the efficacy and toxicity of cancer treatments | Sex-related differences in the efficacy and toxicity of cancer treatments Abstract Differences between the biological sexes have long been observed in cancer incidence and prevalence, and in treatment outcomes including efficacy and toxicity. Ideally, there should be sufficient information to improve the individualizat... |
PMC8944491 | core_pubmed_pmc | Use of Antimicrobials for Bloodstream Infections in the Intensive Care Unit, a Clinically Oriented Review | Use of Antimicrobials for Bloodstream Infections in the Intensive Care Unit, a Clinically Oriented Review Abstract Bloodstream infections (BSIs) in critically ill patients are associated with significant mortality. For patients with septic shock, antibiotics should be administered within the hour. Probabilistic treatme... |
PMC12310844 | core_pubmed_pmc | Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors | Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors Abstract Interleukin (IL)-1 signaling has an essential role in tumor progression and immunosuppression and is linked to acquired re... |
PMC8504835 | core_pubmed_pmc | 3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration | 3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration Abstract Abstract Nonclinical testing has served as a foundation for evaluating potential risks and effectiveness of investigational new drugs in humans. However, the current two‐dimensional (2D) in vitro cell culture systems... |
PMC9580235 | core_pubmed_pmc | Microwave assisted synthesis of 2-amino-4-chloro-pyrimidine derivatives: Anticancer and computational study on potential inhibitory action against COVID-19 | Microwave assisted synthesis of 2-amino-4-chloro-pyrimidine derivatives: Anticancer and computational study on potential inhibitory action against COVID-19 Abstract We report microwave synthesis of seven unique pyrimidine anchored derivatives ( 1 – 7 ) incorporating multifunctional amino derivatives along with their in... |
PMC8247401 | core_pubmed_pmc | Evaluation of clinical and genetic factors in the population pharmacokinetics of carbamazepine | Evaluation of clinical and genetic factors in the population pharmacokinetics of carbamazepine Abstract Aims Carbamazepine can cause hypersensitivity reactions in ~10% of patients. An immunogenic effect can be produced by the electrophilic 10,11‐epoxide metabolite but not by carbamazepine. Hypothetically, certain singl... |
PMC11652821 | core_pubmed_pmc | Prediction of Cardiac ATTR Depletion by NI006 ( ALXN2220 ) Using Mechanistic PK / PD Modeling | Prediction of Cardiac ATTR Depletion by NI006 ( ALXN2220 ) Using Mechanistic PK / PD Modeling Abstract NI006 (aka ALXN2220) is a therapeutic antibody candidate in phase III clinical development for the depletion of amyloid transthyretin (ATTR) in patients with ATTR cardiomyopathy, an infiltrative cardiomyopathy leading... |
PMC8275530 | core_pubmed_pmc | Predictive performance of parent-metabolite population pharmacokinetic models of (S)-ketamine in healthy volunteers | Predictive performance of parent-metabolite population pharmacokinetic models of (S)-ketamine in healthy volunteers Abstract Purpose The recent repurposing of ketamine as treatment for pain and depression has increased the need for accurate population pharmacokinetic (PK) models to inform the design of new clinical tri... |
PMC6853265 | core_pubmed_pmc | The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects | The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects Abstract Abstract Certain patient populations are unable to achieve the recommended low‐density lipoprotein cholesterol goals with statin monotherapy alone.... |
PMC12423301 | core_pubmed_pmc | Astrocytic monoamine oxidase B (MAOB)–gamma-aminobutyric acid (GABA) axis as a molecular brake on repair following spinal cord injury | Astrocytic monoamine oxidase B (MAOB)–gamma-aminobutyric acid (GABA) axis as a molecular brake on repair following spinal cord injury Abstract Neuroregeneration and remyelination rarely occur in the adult mammalian brain and spinal cord following central nervous system (CNS) injury. The glial scar has been proposed as ... |
PMC12706400 | core_pubmed_pmc | QPRapp: A Web‐Based Platform for PK/PD Simulations and Early Feasibility Analysis | QPRapp: A Web‐Based Platform for PK/PD Simulations and Early Feasibility Analysis Abstract ABSTRACT Quantitative pharmacology research application (QPRapp) is a web‐based, interactive, and easy to use Shiny for Python interface, which facilitates evaluation of dose‐exposure relationships, pharmacokinetic/pharmacodynami... |
PMC4184705 | core_pubmed_pmc | A clinical therapeutic protein drug–drug interaction study: coadministration of denosumab and midazolam in postmenopausal women with osteoporosis | A clinical therapeutic protein drug–drug interaction study: coadministration of denosumab and midazolam in postmenopausal women with osteoporosis Abstract Drug–disease interactions involving therapeutic proteins that target cytokines and potentially impact cytochrome P450 (CYP) enzymes have been of increased interest t... |
PMC9608142 | core_pubmed_pmc | Population pharmacokinetic analysis, renal safety, and dosing optimization of polymyxin B in lung transplant recipients with pneumonia: A prospective study | Population pharmacokinetic analysis, renal safety, and dosing optimization of polymyxin B in lung transplant recipients with pneumonia: A prospective study Abstract Objectives: This study aims to characterize the population pharmacokinetics of polymyxin B in lung transplant recipients and optimize its dosage regimens. ... |
PMC3574535 | core_pubmed_pmc | Determination of 17 β-Estradiol in Rabbit Plasma by Gas Chromatography with Flame Ionization Detection | Determination of 17 β-Estradiol in Rabbit Plasma by Gas Chromatography with Flame Ionization Detection Abstract This article describes gas chromatography-flame ionization detection method for determination of 17 β-estradiol in rabbit plasma. 17 β-estradiol and internal standard progesterone were extracted from plasma u... |
PMC7656898 | core_pubmed_pmc | Pulmonary infections complicating ARDS | Pulmonary infections complicating ARDS Abstract Pulmonary infection is one of the main complications occurring in patients suffering from acute respiratory distress syndrome (ARDS). Besides traditional risk factors, dysregulation of lung immune defenses and microbiota may play an important role in ARDS patients. Prone ... |
PMC10027930 | core_pubmed_pmc | Physiologically based pharmacokinetic-pharmacodynamic evaluation of meropenem in CKD and hemodialysis individuals | Physiologically based pharmacokinetic-pharmacodynamic evaluation of meropenem in CKD and hemodialysis individuals Abstract Abstract Objective: Chronic kidney disease (CKD) has significant effects on renal clearance of drugs. The application of antibiotics in CKD patients to achieve the desired therapeutic effect is cha... |
PMC12081532 | core_pubmed_pmc | Pharmacokinetic/Pharmacodynamic Modeling of the Acute Heart Rate Effects of Delta-9 Tetrahydrocannabinol and Its Major Metabolites After Intravenous Injection in Healthy Volunteers | Pharmacokinetic/Pharmacodynamic Modeling of the Acute Heart Rate Effects of Delta-9 Tetrahydrocannabinol and Its Major Metabolites After Intravenous Injection in Healthy Volunteers Abstract Abstract Background and Objectives Cannabis consumption is increasing in both the recreational and medical settings. Tetrahydrocan... |
PMC12845225 | core_pubmed_pmc | Ligustilide: A Phytochemical with Potential in Combating Cancer Development and Progression—A Comprehensive and Critical Review | Ligustilide: A Phytochemical with Potential in Combating Cancer Development and Progression—A Comprehensive and Critical Review Abstract Cancer remains one of the leading global health challenges, with increasing resistance to conventional therapies hindering treatment efficacy. Ligustilide, a bioactive compound derive... |
PMC9942619 | core_pubmed_pmc | Oseltamivir phosphate for suspension is bioequivalent to TAMIFLU in healthy volunteers: a randomized, open-label clinical study | Oseltamivir phosphate for suspension is bioequivalent to TAMIFLU in healthy volunteers: a randomized, open-label clinical study Abstract Purpose The study was aimed at evaluating the bioequivalence and safety of oseltamivir phosphate for suspension, provided by Shenzhen Beimei Pharmaceutical Co. Ltd. and manufactured b... |
PMC3559838 | core_pubmed_pmc | Glucuronidation by UGT1A1 Is the Dominant Pathway of the Metabolic Disposition of Belinostat in Liver Cancer Patients | Glucuronidation by UGT1A1 Is the Dominant Pathway of the Metabolic Disposition of Belinostat in Liver Cancer Patients Abstract Abstract Belinostat is a hydroxamate class HDAC inhibitor that has demonstrated activity in peripheral T-cell lymphoma and is undergoing clinical trials for non-hematologic malignancies. We stu... |
PMC11687313 | core_pubmed_pmc | Population Pharmacokinetics and Dosing Optimization of Norvancomycin for Chinese Patients with Community-Acquired Pneumonia | Population Pharmacokinetics and Dosing Optimization of Norvancomycin for Chinese Patients with Community-Acquired Pneumonia Abstract Abstract Purpose Determining the optimal dosage of norvancomycin (NVCM) for Chinese patients with community-acquired pneumonia (CAP) caused by gram-positive cocci remains uncertain. This ... |
PMC10182601 | core_pubmed_pmc | Biological evaluation of novel gemcitabine analog in patient-derived xenograft models of pancreatic cancer | Biological evaluation of novel gemcitabine analog in patient-derived xenograft models of pancreatic cancer Abstract Gemcitabine (Gem) has been a standard first-line drug for pancreatic cancer (PCa) treatment; however, Gem's rapid metabolism and systemic instability (short half-life) limit its clinical outcome. The obje... |
PMC7226283 | core_pubmed_pmc | Curcumin β‐D‐glucuronide exhibits anti–tumor effects on oxaliplatin‐resistant colon cancer with less toxicity in vivo | Curcumin β‐D‐glucuronide exhibits anti–tumor effects on oxaliplatin‐resistant colon cancer with less toxicity in vivo Abstract Abstract The NF‐kappa B (NF‐κB) pathway plays a pivotal role in tumor progression and chemoresistance, and its inhibition has been shown to suppress tumor growth in a variety of preclinical mod... |
PMC11768447 | core_pubmed_pmc | Sorafenib-Loaded Silica-Containing Redox Nanoparticle Decreases Tumorigenic Potential of Lewis Lung Carcinoma | Sorafenib-Loaded Silica-Containing Redox Nanoparticle Decreases Tumorigenic Potential of Lewis Lung Carcinoma Abstract Background: Orally administered sorafenib has shown limited improvement in overall survival for non-small-cell lung cancer patients, likely due to poor pharmacokinetics and adverse effects, including g... |
PMC8617869 | core_pubmed_pmc | Anti-Hyperglycaemic Evaluation of Buddleia indica Leaves Using In Vitro, In Vivo and In Silico Studies and Its Correlation with the Major Phytoconstituents | Anti-Hyperglycaemic Evaluation of Buddleia indica Leaves Using In Vitro, In Vivo and In Silico Studies and Its Correlation with the Major Phytoconstituents Abstract Buddleia indica Lam. is an ornamental evergreen shrub with few reports concerning its phytoconstituents and biological activities. Herein, the antihypergly... |
PMC7894888 | core_pubmed_pmc | Optimization of Busulfan Dosing Regimen in Pediatric Patients Using a Population Pharmacokinetic Model Incorporating GST Mutations | Optimization of Busulfan Dosing Regimen in Pediatric Patients Using a Population Pharmacokinetic Model Incorporating GST Mutations Abstract Purpose The aim of this study was to develop a novel busulfan dosing regimen, based on a population pharmacokinetic (PPK) model in Chinese children, and to achieve better area unde... |
PMC9787481 | core_pubmed_pmc | A Transversal Approach Combining In Silico, In Vitro and In Vivo Models to Describe the Metabolism of the Receptor Interacting Protein 1 Kinase Inhibitor Sibiriline | A Transversal Approach Combining In Silico, In Vitro and In Vivo Models to Describe the Metabolism of the Receptor Interacting Protein 1 Kinase Inhibitor Sibiriline Abstract Sibiriline is a novel drug inhibiting receptor-interacting protein 1 kinase (RIPK1) and necroptosis, a regulated form of cell death involved in se... |
PMC5754736 | core_pubmed_pmc | Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial | Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial Abstract Objective This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course... |
PMC12444786 | core_pubmed_pmc | Rapid deprotection and purification of ceftaroline free base from its phosphoramidate prodrug | Rapid deprotection and purification of ceftaroline free base from its phosphoramidate prodrug Abstract Abstract Contemporary pharmaceutical design often incorporates functional groups to improve the pharmacokinetic/pharmacodynamic profile of a desired active chemical entity. These compounds are known as prodrugs. While... |
PMC8800323 | core_pubmed_pmc | Beta-lactam dosing during continuous renal replacement therapy: a survey of practices in french intensive care units | Beta-lactam dosing during continuous renal replacement therapy: a survey of practices in french intensive care units Abstract Background Little information is available on current practice in beta-lactam dosing during continuous renal replacement therapy (CRRT). Optimized dosing is essential for improving outcomes, and... |
PMC9841300 | core_pubmed_pmc | Design and conduct considerations for studies in patients with hepatic impairment | Design and conduct considerations for studies in patients with hepatic impairment Abstract Abstract Despite the liver being the primary site for clearance of xenobiotics utilizing a myriad of mechanisms ranging from cytochrome P450 enzyme pathways, glucuronidation, and biliary excretion, there is a dearth of informatio... |
PMC9046595 | core_pubmed_pmc | Pharmacodynamic Evaluation of Zoliflodacin Treatment of Neisseria gonorrhoeae Strains With Amino Acid Substitutions in the Zoliflodacin Target GyrB Using a Dynamic Hollow Fiber Infection Model | Pharmacodynamic Evaluation of Zoliflodacin Treatment of Neisseria gonorrhoeae Strains With Amino Acid Substitutions in the Zoliflodacin Target GyrB Using a Dynamic Hollow Fiber Infection Model Abstract Abstract Novel antimicrobials for effective treatment of uncomplicated gonorrhea are essential, and the first-in-class... |
PMC4228420 | core_pubmed_pmc | DCE@urLAB: a dynamic contrast-enhanced MRI pharmacokinetic analysis tool for preclinical data | DCE@urLAB: a dynamic contrast-enhanced MRI pharmacokinetic analysis tool for preclinical data Abstract Background DCE@urLAB is a software application for analysis of dynamic contrast-enhanced magnetic resonance imaging data (DCE-MRI). The tool incorporates a friendly graphical user interface (GUI) to interactively sele... |
PMC9858383 | core_pubmed_pmc | Antiretroviral Levels in the Cerebrospinal Fluid: The Effect of Inflammation and Genetic Variants | Antiretroviral Levels in the Cerebrospinal Fluid: The Effect of Inflammation and Genetic Variants Abstract Neurocognitive impairments are common in people living with HIV. Some conditions, such as chronic inflammation, astrocyte infection and an impaired blood–brain barrier (BBBi), along with host genetic variants in t... |
PMC5080787 | core_pubmed_pmc | Decreased absorption of midazolam in the stomach due to low pH induced by co-administration of Banha-sasim-tang | Decreased absorption of midazolam in the stomach due to low pH induced by co-administration of Banha-sasim-tang Abstract Abstract Objectives Banha-sasim-tang (BST), which consists of seven different herbs, is one of the most popular herbal formulae for treating gastrointestinal disorders in Eastern Asia. The commonly u... |
PMC12567097 | core_pubmed_pmc | 1-Nitro-2-Phenylethane as a Multitarget Candidate for Cognitive and Psychiatric Disorders: Insights from In Silico and Behavioral Approaches | 1-Nitro-2-Phenylethane as a Multitarget Candidate for Cognitive and Psychiatric Disorders: Insights from In Silico and Behavioral Approaches Abstract Background/Objectives : Neurological and psychiatric disorders share overlapping mechanisms, such as oxidative stress, neuroinflammation, and neurotransmitter imbalance. ... |
PMC8602797 | core_pubmed_pmc | Natural Products for the Management of Castration-Resistant Prostate Cancer: Special Focus on Nanoparticles Based Studies | Natural Products for the Management of Castration-Resistant Prostate Cancer: Special Focus on Nanoparticles Based Studies Abstract Prostate cancer is the most common type of cancer among men and the second most frequent cause of cancer-related mortality around the world. The progression of advanced prostate cancer to c... |
PMC5732384 | core_pubmed_pmc | Cellular pharmacodynamic effects of Pycnogenol® in patients with severe osteoarthritis: a randomized controlled pilot study | Cellular pharmacodynamic effects of Pycnogenol® in patients with severe osteoarthritis: a randomized controlled pilot study Abstract Abstract Background The standardized maritime pine bark extract (Pycnogenol®) has previously shown symptom alleviating effects in patients suffering from moderate forms of knee osteoarthr... |
PMC9290854 | core_pubmed_pmc | The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis | The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis Abstract Dupilumab demonstrated efficacy with an acceptable safety profile in two randomized, double‐blind, placebo‐controlled, parallel‐group, phase III trials in adolescents (12–17 years; LIBERTY AD ADOL) and children (6–11 years; LIBERTY AD PEDS)... |
PMC10766679 | core_pubmed_pmc | The Effects of Bariatric Surgery on Pharmacokinetics of Drugs: a Review of Current Evidence | The Effects of Bariatric Surgery on Pharmacokinetics of Drugs: a Review of Current Evidence Abstract Purpose of Review Obesity constitutes a major public health concern and has been recognized as an epidemic. To date, bariatric surgery remains the most effective way for substantial long-lasting weight loss in severe ob... |
PMC10458652 | core_pubmed_pmc | Effect of Gut Microbiota on the Pharmacokinetics of Nifedipine in Spontaneously Hypertensive Rats | Effect of Gut Microbiota on the Pharmacokinetics of Nifedipine in Spontaneously Hypertensive Rats Abstract Abstract The pharmacokinetic variability of nifedipine widely observed in the clinic cannot be fully explained by pharmacogenomics. As a new factor affecting drug metabolism, how the gut microbiota affects the pha... |
PMC11344531 | core_pubmed_pmc | Phase I studies of davoceticept (ALPN-202), a PD-L1-dependent CD28 co-stimulator and dual PD-L1/CTLA-4 inhibitor, as monotherapy and in combination with pembrolizumab in advanced solid tumors (NEON-1 and NEON-2) | Phase I studies of davoceticept (ALPN-202), a PD-L1-dependent CD28 co-stimulator and dual PD-L1/CTLA-4 inhibitor, as monotherapy and in combination with pembrolizumab in advanced solid tumors (NEON-1 and NEON-2) Abstract Abstract Background Davoceticept (ALPN-202) is an Fc fusion of a CD80 variant immunoglobulin domain... |
PMC9877749 | core_pubmed_pmc | Physiologically‐based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID ‐19 | Physiologically‐based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID ‐19 Abstract Abstract Pregnant individuals are at high risk for severe illness from COVID‐19, and there is an urgent need to identify safe and effective therapeutics for this population. Remdesivir (RDV) is a S... |
PMC6311297 | core_pubmed_pmc | Effects of Plasma Albumin on the Pharmacokinetics of Esomeprazole in ICU Patients | Effects of Plasma Albumin on the Pharmacokinetics of Esomeprazole in ICU Patients Abstract Objectives To evaluate the effects of plasma albumin on pharmacokinetics of esomeprazole in ICU patients. Methods This study was performed in 32 consecutive intensive care unit (ICU) patients. They were divided into two groups ac... |
PMC11126055 | core_pubmed_pmc | Pharmacokinetic and Environmental Risk Assessment of Prime-2-CoV, a Non-Replicating Orf Virus-Based Vaccine against SARS-CoV-2 | Pharmacokinetic and Environmental Risk Assessment of Prime-2-CoV, a Non-Replicating Orf Virus-Based Vaccine against SARS-CoV-2 Abstract Abstract Viral vector vaccines represent a substantial advancement in immunization technology, offering numerous benefits over traditional vaccine modalities. The Orf virus (ORFV) stra... |
PMC9835135 | core_pubmed_pmc | Predicting the correct dose in children: Role of computational Pediatric Physiological‐based pharmacokinetics modeling tools | Predicting the correct dose in children: Role of computational Pediatric Physiological‐based pharmacokinetics modeling tools Abstract Abstract The pharmacokinetics (PKs) and safety of medications in particular groups can be predicted using the physiologically‐based pharmacokinetic (PBPK) model. Using the PBPK model may... |
PMC6680484 | core_pubmed_pmc | Detection of 13 Ginsenosides (Rb1, Rb2, Rc, Rd, Re, Rf, Rg1, Rg3, Rh2, F1, Compound K, 20( S )-Protopanaxadiol, and 20( S )-Protopanaxatriol) in Human Plasma and Application of the Analytical Method to Human Pharmacokinetic Studies Following Two Week-Repeated Administration of Red Ginseng Extract | Detection of 13 Ginsenosides (Rb1, Rb2, Rc, Rd, Re, Rf, Rg1, Rg3, Rh2, F1, Compound K, 20( S )-Protopanaxadiol, and 20( S )-Protopanaxatriol) in Human Plasma and Application of the Analytical Method to Human Pharmacokinetic Studies Following Two Week-Repeated Administration of Red Ginseng Extract Abstract Abstract We a... |
PMC10520167 | core_pubmed_pmc | Towards Model-Informed Precision Dosing of Voriconazole: Challenging Published Voriconazole Nonlinear Mixed-Effects Models with Real-World Clinical Data | Towards Model-Informed Precision Dosing of Voriconazole: Challenging Published Voriconazole Nonlinear Mixed-Effects Models with Real-World Clinical Data Abstract Background and Objectives Model-informed precision dosing (MIPD) frequently uses nonlinear mixed-effects (NLME) models to predict and optimize therapy outcome... |
PMC7615782 | core_pubmed_pmc | Treosulfan Exposure Predicts Thalassemia-Free Survival in Patients with Beta Thalassemia Major Undergoing Allogeneic Hematopoietic Cell Transplantation | Treosulfan Exposure Predicts Thalassemia-Free Survival in Patients with Beta Thalassemia Major Undergoing Allogeneic Hematopoietic Cell Transplantation Abstract Abstract A toxicity-reduced conditioning regimen with treosulfan, fludarabine, and thiotepa in patients with high-risk β-thalassemia major has significantly im... |
PMC12962861 | core_pubmed_pmc | Turoctocog alfa pegol versus recombinant factor VIII-Fc fusion protein: a head-to-head pharmacokinetics comparison | Turoctocog alfa pegol versus recombinant factor VIII-Fc fusion protein: a head-to-head pharmacokinetics comparison Methods Laboratory methods Coamatic FVIII reagent (Chromogenix, Werfen, Barcelona, Spain) was used in a chromogenic substrate assay (CSA) on an ACL TOP750® (Werfen). No specific calibrator was used to cons... |
PMC5794849 | core_pubmed_pmc | Absorption, Distribution, Metabolism, and Excretion of [ 14 C]-Volixibat in Healthy Men: Phase 1 Open-Label Study | Absorption, Distribution, Metabolism, and Excretion of [ 14 C]-Volixibat in Healthy Men: Phase 1 Open-Label Study Abstract Abstract Background and Objectives Volixibat is a potent inhibitor of the apical sodium-dependent bile acid transporter in development for the treatment of nonalcoholic steatohepatitis. This phase ... |
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