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PMC12536525
core_pubmed_pmc
Clinical pharmacist-led medication review in patients with sepsis and septic shock in the intensive care unit: a non-randomized controlled study
Clinical pharmacist-led medication review in patients with sepsis and septic shock in the intensive care unit: a non-randomized controlled study Abstract Background Polypharmacy, resulting from the medications used in the management of sepsis, along with the pharmacokinetic changes induced by sepsis, can place this pat...
PMC7749407
core_pubmed_pmc
Vanucizumab mode of action: Serial biomarkers in plasma, tumor, and skin-wound-healing biopsies
Vanucizumab mode of action: Serial biomarkers in plasma, tumor, and skin-wound-healing biopsies Abstract Highlights • Angiogenesis is critical to the development and survival of solid tumors. • Vanucizumab inhibits both vascular endothelial growth factor and angiopoietin-2. • Vanucizumab exhibits anti-tumor, anti-angio...
PMC10294342
core_pubmed_pmc
SipNose-topiramate: a potential novel approach to binge eating management
SipNose-topiramate: a potential novel approach to binge eating management Abstract Background Binge-eating disorder) BED) is the most common eating disorder in the United-States. Daily, orally administered topiramate has shown BED treatment efficacy, with two major limitations: frequent and severe side effects and slow...
PMC10233426
core_pubmed_pmc
Austalide derivative from marine-derived Aspergillus sp. and evaluation of its cytotoxic and ADME/TOPKAT properties †
Austalide derivative from marine-derived Aspergillus sp. and evaluation of its cytotoxic and ADME/TOPKAT properties † Abstract In-depth chemical investigation of an ethyl acetate extract of Aspergillus sp. isolated from the soft coral Sinularia species resulted in the isolation of one new meroterpenoid, austalide Z (1)...
PMC11682980
core_pubmed_pmc
What are clinically significant anti-drug antibodies and why is it important to identify them
What are clinically significant anti-drug antibodies and why is it important to identify them Abstract Abstract The FDA has released new draft guidance to standardize how immunogenicity of protein therapeutics is described in product labels. A key aspect to this new guidance is that companies should describe anti-drug ...
PMC7470105
core_pubmed_pmc
Bioavailability of oxycodone by mouth in coronary artery bypass surgery patients – a randomized trial
Bioavailability of oxycodone by mouth in coronary artery bypass surgery patients – a randomized trial Abstract Abstract Objective Pain after coronary artery by-pass (CAB) surgery is severe. Analgesic administration by mouth is unreliable until after gastrointestinal function has recovered. We evaluated the bioavailabil...
PMC6263663
core_pubmed_pmc
Population Pharmacokinetics and Exploratory Exposure‐Response Relationships of Diazepam in Children Treated for Status Epilepticus
Population Pharmacokinetics and Exploratory Exposure‐Response Relationships of Diazepam in Children Treated for Status Epilepticus Abstract Abstract Diazepam is labeled for status epilepticus (SE) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pha...
PMC12945714
core_pubmed_pmc
Population PK/PD Modeling for Evaluation of Intertwining Effects of Drug and Disease on Thrombocytopenia in Acute Leukemias
Population PK/PD Modeling for Evaluation of Intertwining Effects of Drug and Disease on Thrombocytopenia in Acute Leukemias Abstract ABSTRACT In hematological malignancies, thrombocytopenia is a frequent feature of the disease. Anti‐leukemic therapies are known to impact thrombocytopenia, which is commonly selected as ...
PMC6614128
core_pubmed_pmc
Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies
Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies Abstract Abstract In this work, a previously developed pegfilgrastim (PG) population pharmacokinetic-pharmacodynamic (PKPD) model was used to evaluate potential factors of importance in the assessmen...
PMC7586977
core_pubmed_pmc
The Effect of Food on the Single‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine
The Effect of Food on the Single‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine Abstract Abstract Duloxetine is a combined serotonin and norepinephrine reuptake inhibitor indicated in adults for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, and g...
PMC10997509
core_pubmed_pmc
Increase in peg-asparaginase clearance as a predictor for inactivation in patients with acute lymphoblastic leukemia
Increase in peg-asparaginase clearance as a predictor for inactivation in patients with acute lymphoblastic leukemia Abstract Asparaginase is an essential component of acute lymphoblastic leukemia (ALL) therapy, yet its associated toxicities often lead to treatment discontinuation, increasing the risk of relapse. Hyper...
PMC12171725
core_pubmed_pmc
Phenyltriazole-based sulfonamides: novel dual-target agents against MRSA biofilms and resistant pathogens †
Phenyltriazole-based sulfonamides: novel dual-target agents against MRSA biofilms and resistant pathogens † Abstract Abstract The advent of multidrug-resistant bacteria requires the continuous development of new antimicrobial agents. A series of phenyltriazole–sulfonamide hybrid compounds (16–27) have been synthesized ...
PMC12723143
core_pubmed_pmc
Impact of different doses of rivaroxaban on clinical outcomes in elderly patients with non-valvular atrial fibrillation: a real-world study
Impact of different doses of rivaroxaban on clinical outcomes in elderly patients with non-valvular atrial fibrillation: a real-world study Abstract Abstract Introduction This study to assess the associations between different rivaroxaban doses and clinical outcomes in elderly NVAF patients in a real-world setting, and...
PMC6484215
core_pubmed_pmc
The effect of chronic kidney disease on CYP2B expression and activity in male Wistar rats
The effect of chronic kidney disease on CYP2B expression and activity in male Wistar rats Abstract Abstract Chronic kidney disease (CKD) is characterized by progressive reduction in kidney function over time. CKD affects greater than 10% of the population and its incidence is on the rise due to the growing prevalence o...
PMC6249307
core_pubmed_pmc
Integrated mapping of pharmacokinetics and pharmacodynamics in a patient-derived xenograft model of glioblastoma
Integrated mapping of pharmacokinetics and pharmacodynamics in a patient-derived xenograft model of glioblastoma Abstract Abstract Therapeutic options for the treatment of glioblastoma remain inadequate despite concerted research efforts in drug development. Therapeutic failure can result from poor permeability of the ...
PMC11356605
core_pubmed_pmc
Retrospective Study of Factors Affecting the Accuracy of Predicting Vancomycin Concentrations in Patients Aged 75 Years and Above
Retrospective Study of Factors Affecting the Accuracy of Predicting Vancomycin Concentrations in Patients Aged 75 Years and Above Abstract Abstract Background and Objectives : The predicted serum concentrations of vancomycin are determined using population pharmacokinetic parameters. However, the accuracy of predicting...
PMC9755916
core_pubmed_pmc
Evaluation of machine learning methods for covariate data imputation in pharmacometrics
Evaluation of machine learning methods for covariate data imputation in pharmacometrics Abstract Abstract Missing data create challenges in clinical research because they lead to loss of statistical power and potentially to biased results. Missing covariate data must be handled with suitable approaches to prepare datas...
PMC3352075
core_pubmed_pmc
Epidemiology and antifungal resistance in invasive candidiasis
Epidemiology and antifungal resistance in invasive candidiasis Abstract The epidemiology of Candida infections has changed over the last two decades: The number of patients suffering from such infections has increased dramatically and the Candida species involved have become more numerous as Candida albicans is replace...
PMC6441232
core_pubmed_pmc
Optimization of the treatment with beta-lactam antibiotics in critically ill patients—guidelines from the French Society of Pharmacology and Therapeutics (Société Française de Pharmacologie et Thérapeutique—SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Société Française d’Anesthésie et Réanim...
Optimization of the treatment with beta-lactam antibiotics in critically ill patients—guidelines from the French Society of Pharmacology and Therapeutics (Société Française de Pharmacologie et Thérapeutique—SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Société Française d’Anesthésie et Réanim...
PMC9290939
core_pubmed_pmc
Physiologically based pharmacokinetic modelling of treprostinil after intravenous injection and extended‐release oral tablet administration in healthy volunteers: An extrapolation to other patient populations including patients with hepatic impairment
Physiologically based pharmacokinetic modelling of treprostinil after intravenous injection and extended‐release oral tablet administration in healthy volunteers: An extrapolation to other patient populations including patients with hepatic impairment Abstract Abstract Aims Pulmonary arterial hypertension (PAH) is char...
PMC10905684
core_pubmed_pmc
Unveiling the potential anti‐cancer activity of calycosin against multivarious cancers with molecular insights: A promising frontier in cancer research
Unveiling the potential anti‐cancer activity of calycosin against multivarious cancers with molecular insights: A promising frontier in cancer research Abstract Abstract Background Calycosin may be a potential candidate regarding chemotherapeutic agent, because already some studies against multivarious cancer have been...
PMC12858916
core_pubmed_pmc
Sorafenib plus selective internal radiotherapy with 90 Y resin microspheres for the treatment of uveal melanoma with liver metastasis: a phase I trial
Sorafenib plus selective internal radiotherapy with 90 Y resin microspheres for the treatment of uveal melanoma with liver metastasis: a phase I trial Abstract Abstract Introduction Selective internal radiation therapy (SIRT) and sorafenib are used for patients with liver metastases from uveal melanoma. We conducted a ...
PMC9349143
core_pubmed_pmc
Clinical Pharmacokinetics of Gentamicin in Various Patient Populations and Consequences for Optimal Dosing for Gram-Negative Infections: An Updated Review
Clinical Pharmacokinetics of Gentamicin in Various Patient Populations and Consequences for Optimal Dosing for Gram-Negative Infections: An Updated Review Abstract Gentamicin is an aminoglycoside antibiotic with a small therapeutic window that is currently used primarily as part of short-term empirical combination ther...
PMC4618628
core_pubmed_pmc
A window-of-opportunity biomarker study of etodolac in resectable breast cancer
A window-of-opportunity biomarker study of etodolac in resectable breast cancer Abstract Observational data show that nonsteroidal anti-inflammatory drug (NSAID) use is associated with a lower rate of breast cancer. We evaluated the effect of etodolac, an FDA-approved NSAID reported to inhibit cyclooxygenase (COX) enzy...
PMC3575177
core_pubmed_pmc
Preparation and in vitro and in vivo characterization of cyclosporin A-loaded, PEGylated chitosan-modified, lipid-based nanoparticles
Preparation and in vitro and in vivo characterization of cyclosporin A-loaded, PEGylated chitosan-modified, lipid-based nanoparticles Abstract Abstract Background and methods: A new cyclosporin A-loaded, PEGylated chitosan-modified lipid-based nanoparticle was developed to improve upon the formulation of cyclosporin A....
PMC9790963
core_pubmed_pmc
First-in-human study to assess the safety, tolerability, pharmacokinetics and immunogenicity of DS002, an anti-nerve growth factor monoclonal antibody
First-in-human study to assess the safety, tolerability, pharmacokinetics and immunogenicity of DS002, an anti-nerve growth factor monoclonal antibody Abstract Abstract Purpose: To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of DS002 injection, an anti-nerve growth factor (anti-NGF) monoclona...
PMC6532211
core_pubmed_pmc
Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration
Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration Abstract Background ONC201 is a small molecule antagonist of DRD2, a G protein-coupled receptor overexpressed in several malignancies, that has prolonged antitumor efficacy and i...
PMC12104600
core_pubmed_pmc
Unintentional amitriptyline overdose leading to coma and cardiac conduction impairment in an older adult: A case report
Unintentional amitriptyline overdose leading to coma and cardiac conduction impairment in an older adult: A case report Abstract Abstract Elderly patients are particularly vulnerable to look-alike/sound-alike medication errors due to physiological differences that alter medication pharmacokinetics and pharmacodynamics....
PMC5315734
core_pubmed_pmc
Allometric Scaling of Clearance in Paediatric Patients: When Does the Magic of 0.75 Fade?
Allometric Scaling of Clearance in Paediatric Patients: When Does the Magic of 0.75 Fade? Abstract Abstract Allometric scaling on the basis of bodyweight raised to the power of 0.75 (AS0.75) is frequently used to scale size-related changes in plasma clearance (CL p ) from adults to children. A systematic assessment of ...
PMC8292521
core_pubmed_pmc
Renal 99m Tc-DMSA pharmacokinetics in pediatric patients
Renal 99m Tc-DMSA pharmacokinetics in pediatric patients Abstract Abstract Abstract 99m Tc-DMSA is one of the most commonly used pediatric nuclear medicine imaging agents. Nevertheless, there are no pharmacokinetic (PK) models for 99m Tc-DMSA in children, and currently available pediatric dose estimates for 99m Tc-DMSA...
PMC8079036
core_pubmed_pmc
Inhalation delivery dramatically improves the efficacy of topotecan for the treatment of local and distant lung cancer
Inhalation delivery dramatically improves the efficacy of topotecan for the treatment of local and distant lung cancer Abstract Abstract Topotecan is potent anti-cancer drug approved for various malignancies but hematopoietic toxicities undermine its wider application and use of its most effective dose. This study aims...
PMC9305530
core_pubmed_pmc
Effects of dalteparin on anti‐Xa activities cannot be predicted in critically ill COVID‐19 patients
Effects of dalteparin on anti‐Xa activities cannot be predicted in critically ill COVID‐19 patients Abstract Critically ill COVID‐19 patients are at high risk of thromboembolic events despite routine‐dosed low‐molecular‐weight heparin thromboprophylaxis. However, in recent randomized trials increased‐intensity thrombop...
PMC8572577
core_pubmed_pmc
Therapeutic potential of triptolide in autoimmune diseases and strategies to reduce its toxicity
Therapeutic potential of triptolide in autoimmune diseases and strategies to reduce its toxicity Abstract Abstract With the increasing epidemiology of autoimmune disease worldwide, there is an urgent need for effective drugs with low cost in clinical treatment. Triptolide, the most potent bioactive compound from tradit...
PMC6771164
core_pubmed_pmc
Liver‐Targeted Toll‐Like Receptor 7 Agonist Combined With Entecavir Promotes a Functional Cure in the Woodchuck Model of Hepatitis B Virus
Liver‐Targeted Toll‐Like Receptor 7 Agonist Combined With Entecavir Promotes a Functional Cure in the Woodchuck Model of Hepatitis B Virus Abstract Current therapeutics for chronic infection with hepatitis B virus (HBV) rarely induce functional cure due to the immunotolerant status of patients. Small molecule agonists ...
PMC3554734
core_pubmed_pmc
Comparison of Nevirapine Plasma Concentrations between Lead-In and Steady-State Periods in Chinese HIV-Infected Patients
Comparison of Nevirapine Plasma Concentrations between Lead-In and Steady-State Periods in Chinese HIV-Infected Patients Abstract Abstract Objectives To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations. Methods This was ...
PMC9142570
core_pubmed_pmc
Population pharmacokinetics and dose optimization of intravenous levofloxacin in hospitalized adult patients
Population pharmacokinetics and dose optimization of intravenous levofloxacin in hospitalized adult patients Abstract Although levofloxacin has been used for the last 25 years, there are limited pharmacokinetic data to guide levofloxacin dosing in adult patients. This study aimed to develop a population pharmacokinetic...
PMC12887396
core_pubmed_pmc
Safety, tolerability, pharmacokinetics, and pharmacodynamics of KN060, a humanized anti-FXI/FXIa dual-domain antibody, following single ascending doses in healthy Chinese subjects
Safety, tolerability, pharmacokinetics, and pharmacodynamics of KN060, a humanized anti-FXI/FXIa dual-domain antibody, following single ascending doses in healthy Chinese subjects Abstract Background KN060 is a humanized dual-domain antibody targeting coagulation factor XI (FXI) and factor XIa (FXIa) and is currently b...
PMC8469489
core_pubmed_pmc
Effect of Lactic Acid Bacteria on the Pharmacokinetics and Metabolism of Ginsenosides in Mice
Effect of Lactic Acid Bacteria on the Pharmacokinetics and Metabolism of Ginsenosides in Mice Abstract Abstract This study aims to investigate the effect of lactic acid bacteria (LAB) on in vitro and in vivo metabolism and the pharmacokinetics of ginsenosides in mice. When the in vitro fermentation test of RGE with LAB...
PMC4577251
core_pubmed_pmc
Clinically significant drug–drug interactions involving opioid analgesics used for pain treatment in patients with cancer: a systematic review
Clinically significant drug–drug interactions involving opioid analgesics used for pain treatment in patients with cancer: a systematic review Abstract Abstract Background Opioids are the most frequently used drugs to treat pain in cancer patients. In some patients, however, opioids can cause adverse effects and drug–d...
PMC4842247
core_pubmed_pmc
LC-MS Method for Studying the Pharmacokinetics and Bioequivalence of Clonidine Hydrochloride in Healthy Male Volunteers
LC-MS Method for Studying the Pharmacokinetics and Bioequivalence of Clonidine Hydrochloride in Healthy Male Volunteers Abstract Background: A simple and sensitive high performance liquid chromatography-electrospray ionization mass spectrometry method has been evaluated for the assignment of clonidine hydrochloride in ...
PMC12823301
core_pubmed_pmc
Population Pharmacokinetics and Exposure‐Response Model‐Based Bayesian Extrapolation of FVC ‐Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib
Population Pharmacokinetics and Exposure‐Response Model‐Based Bayesian Extrapolation of FVC ‐Based Efficacy Endpoints From Adults to Pediatric Patients Receiving Nintedanib Abstract ABSTRACT Nintedanib reduces the rate of decline in forced vital capacity (FVC) in adult patients with idiopathic pulmonary fibrosis (IPF),...
PMC6235005
core_pubmed_pmc
Species difference in paclitaxel disposition correlated with poor pharmacological efficacy translation from mice to humans
Species difference in paclitaxel disposition correlated with poor pharmacological efficacy translation from mice to humans Abstract Abstract Background Paclitaxel (PTX) products currently approved by the Food and Drug Administration include Kolliphor EL-paclitaxel micelles (KoEL-paclitaxel, Taxol) and nanoparticle albu...
PMC10634426
core_pubmed_pmc
Effectiveness of dapagliflozin as an insulin adjunct in type 1 diabetes: a semi-mechanistic exposure-response model
Effectiveness of dapagliflozin as an insulin adjunct in type 1 diabetes: a semi-mechanistic exposure-response model Abstract Introduction: Dapagliflozin-induced improvement of glycemic control in patients with inadequately controlled type 1 diabetes (T1D) is complicated by the delicate balance between blood glucose and...
PMC9338675
core_pubmed_pmc
Subcutaneous administration, higher age and lower renal function are associated with erythrocyte methotrexate accumulation in Crohn’s disease: a cross-sectional study
Subcutaneous administration, higher age and lower renal function are associated with erythrocyte methotrexate accumulation in Crohn’s disease: a cross-sectional study Abstract Background Methotrexate is an immunomodulatory drug for patients with Crohn’s disease. Erythrocyte MTX-polyglutamates (MTX-PG 1-5 ) may be used ...
PMC10390421
core_pubmed_pmc
Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial
Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial Abstract Introduction Bamlanivimab and etesevimab (BAM + ETE) are monoclonal antibodies (mAbs) effective in reducing COVID-19-related hospitaliz...
PMC4433689
core_pubmed_pmc
Curcumin Pharmacokinetic and Pharmacodynamic Evidences in Streptozotocin-Diabetic Rats Support the Antidiabetic Activity to Be via Metabolite(s)
Curcumin Pharmacokinetic and Pharmacodynamic Evidences in Streptozotocin-Diabetic Rats Support the Antidiabetic Activity to Be via Metabolite(s) Abstract This study measures the curcumin concentration in rat plasma by liquid chromatography and investigates the changes in the glucose tolerance and insulin sensitivity of...
PMC9866847
core_pubmed_pmc
Recent Advances in Targeted Nanocarriers for the Management of Triple Negative Breast Cancer
Recent Advances in Targeted Nanocarriers for the Management of Triple Negative Breast Cancer Abstract Abstract Triple-negative breast cancer (TNBC) is a life-threatening form of breast cancer which has been found to account for 15% of all the subtypes of breast cancer. Currently available treatments are significantly l...
PMC5059376
core_pubmed_pmc
Rapid absorption of diclofenac and acetaminophen after their oral administration to cattle
Rapid absorption of diclofenac and acetaminophen after their oral administration to cattle Abstract The oral pharmacokinetics of diclofenac (DF) were evaluated in cattle by analyzing plasma concentration-time data after its intravenous and oral administration in order to propose the oral administration of DF as effecti...
PMC11727843
core_pubmed_pmc
Impact of DPP-4 Inhibitors in Patients with Diabetes Mellitus and Heart Failure: An In-Depth Review
Impact of DPP-4 Inhibitors in Patients with Diabetes Mellitus and Heart Failure: An In-Depth Review Abstract The increasing prevalence of both type 2 diabetes mellitus and heart failure has underscored the urgent need for optimized therapeutic strategies that address the complex interplay between these conditions. Dipe...
PMC4573071
core_pubmed_pmc
Exposure–response model for sibutramine and placebo: suggestion for application to long-term weight-control drug development
Exposure–response model for sibutramine and placebo: suggestion for application to long-term weight-control drug development Abstract No wholly successful weight-control drugs have been developed to date, despite the tremendous demand. We present an exposure–response model of sibutramine mesylate that can be applied du...
PMC12962397
core_pubmed_pmc
Physiologically Based Pharmacokinetic Virtual Twin Approach for Fludarabine Dosing in Pediatric Hematopoietic Stem Cell Transplantation
Physiologically Based Pharmacokinetic Virtual Twin Approach for Fludarabine Dosing in Pediatric Hematopoietic Stem Cell Transplantation Abstract ABSTRACT Fludarabine (Flu), administered as a prodrug Flu monophosphate, is a lymphodepleting agent used prior to hematopoietic stem cell transplantation (HSCT) which exhibits...
PMC8846319
core_pubmed_pmc
Population Pharmacokinetic and Concentration-QTc Analysis of Delamanid in Pediatric Participants with Multidrug-Resistant Tuberculosis
Population Pharmacokinetic and Concentration-QTc Analysis of Delamanid in Pediatric Participants with Multidrug-Resistant Tuberculosis Abstract ABSTRACT A population pharmacokinetic analysis of delamanid and its major metabolite DM-6705 was conducted to characterize the pharmacokinetics of delamanid and DM-6705 in pedi...
PMC9788092
core_pubmed_pmc
c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper
c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper Abstract Abstract Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and...
PMC7033535
core_pubmed_pmc
Comparative pharmacokinetic and tolerability evaluation of two simvastatin 20 mg formulations in healthy Korean male volunteers
Comparative pharmacokinetic and tolerability evaluation of two simvastatin 20 mg formulations in healthy Korean male volunteers Abstract Abstract Simvastatin is used to reduce plasma cholesterol by inhibiting 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase and is primarily used to treat hypercholesterolemia. ...
PMC9230797
core_pubmed_pmc
Integration of a Physiologically Based Pharmacokinetic and Pharmacodynamic Model for Tegoprazan and Its Metabolite: Application for Predicting Food Effect and Intragastric pH Alterations
Integration of a Physiologically Based Pharmacokinetic and Pharmacodynamic Model for Tegoprazan and Its Metabolite: Application for Predicting Food Effect and Intragastric pH Alterations Abstract A physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) model for tegoprazan and its major metabolite M1 was devel...
PMC10092127
core_pubmed_pmc
Probability of Target Attainment Analyses to Inform Ceftolozane/Tazobactam Dosing Regimens for Patients With Hospital‐Acquired or Ventilator‐Associated Bacterial Pneumonia and End‐Stage Renal Disease Receiving Intermittent Hemodialysis
Probability of Target Attainment Analyses to Inform Ceftolozane/Tazobactam Dosing Regimens for Patients With Hospital‐Acquired or Ventilator‐Associated Bacterial Pneumonia and End‐Stage Renal Disease Receiving Intermittent Hemodialysis Abstract Abstract ASPECT‐NP, a phase 3 trial of ceftolozane/tazobactam in hospital‐a...
PMC9543781
core_pubmed_pmc
Lack of clinically relevant differences in safety and pharmacokinetics after second‐dose administration of intranasal diazepam within 4 h for acute treatment of seizure clusters: A population analysis
Lack of clinically relevant differences in safety and pharmacokinetics after second‐dose administration of intranasal diazepam within 4 h for acute treatment of seizure clusters: A population analysis Abstract Abstract Objective Current diazepam nasal spray labeling requires waiting 4 h before administering a second do...
PMC9929104
core_pubmed_pmc
First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors Abstract PURPOSE OBI-999 is a novel antibody-drug conjugate comprising the Globo H–targeting antibody (OBI-888) linked to the cytotoxic payload monomethyl auristatin E. OBI-999 demonstrated excellent dos...
PMC10309531
core_pubmed_pmc
Unraveling Dexamethasone-Induced Neurobehavioral and Sleep Problems in Children With ALL: Which Determinants Are Important?
Unraveling Dexamethasone-Induced Neurobehavioral and Sleep Problems in Children With ALL: Which Determinants Are Important? Abstract PURPOSE Dexamethasone, the preferred corticosteroid in most treatment protocols for pediatric acute lymphoblastic leukemia (ALL), can induce undesirable side effects. Neurobehavioral and ...
PMC7085998
core_pubmed_pmc
Radiprodil, a NR2B negative allosteric modulator, from bench to bedside in infantile spasm syndrome
Radiprodil, a NR2B negative allosteric modulator, from bench to bedside in infantile spasm syndrome Abstract Abstract Objective Infantile spasm syndrome (ISS) is an epileptic encephalopathy without established treatment after the failure to standard of care based on steroids and vigabatrin. Converging lines of evidence...
PMC9468563
core_pubmed_pmc
The pharmacokinetic, safety, and tolerability profiles of eslicarbazepine acetate are comparable between Korean and White subjects
The pharmacokinetic, safety, and tolerability profiles of eslicarbazepine acetate are comparable between Korean and White subjects Abstract Abstract Eslicarbazepine acetate (ESL) is a prodrug antiseizure medication for the treatment of focal seizures. ESL shows a well‐established pharmacokinetic (PK)‐pharmacodynamic re...
PMC5487385
core_pubmed_pmc
Pharmacokinetic/Pharmacodynamic Modeling of Tulathromycin against Pasteurella multocida in a Porcine Tissue Cage Model
Pharmacokinetic/Pharmacodynamic Modeling of Tulathromycin against Pasteurella multocida in a Porcine Tissue Cage Model Abstract Tulathromycin, a macrolide antibiotic, is used for the treatment of respiratory disease in cattle and swine. The aim of our study was to investigate the in vitro and ex vivo activities of tula...
PMC4697357
core_pubmed_pmc
INTRAVITREAL CORTICOSTEROIDS IN DIABETIC MACULAR EDEMA
INTRAVITREAL CORTICOSTEROIDS IN DIABETIC MACULAR EDEMA Abstract This article reviews the safety, efficacy, and pharmacokinetics of several approved formulations of intravitreal corticosteroids for the treatment of diabetic macular edema (including triamcinolone acetonide, dexamethasone, and fluocinolone acetonide) and ...
PMC4755689
core_pubmed_pmc
Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis
Pharmacokinetics of daclizumab high-yield process with repeated administration of the clinical subcutaneous regimen in patients with relapsing-remitting multiple sclerosis Abstract Abstract Background Daclizumab high-yield process (DAC HYP), a humanized immunoglobulin G1 monoclonal antibody specific for the α subunit (...
PMC9652212
core_pubmed_pmc
Quantification of the Time Course of CYP3A Inhibition, Activation, and Induction Using a Population Pharmacokinetic Model of Microdosed Midazolam Continuous Infusion
Quantification of the Time Course of CYP3A Inhibition, Activation, and Induction Using a Population Pharmacokinetic Model of Microdosed Midazolam Continuous Infusion Abstract Abstract Background Cytochrome P450 (CYP) 3A contributes to the metabolism of many approved drugs. CYP3A perpetrator drugs can profoundly alter t...
PMC11476771
core_pubmed_pmc
Impact of renal impairment on the pharmacokinetic profile of intravenous difelikefalin, a kappa opioid receptor agonist for the treatment of pruritus
Impact of renal impairment on the pharmacokinetic profile of intravenous difelikefalin, a kappa opioid receptor agonist for the treatment of pruritus Abstract Abstract Background Difelikefalin is a selective kappa opioid receptor agonist that is approved for the treatment of moderate-to-severe pruritus associated with ...
PMC12298458
core_pubmed_pmc
Novel Micellar Formulation of Silymarin (Milk Thistle) with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
Novel Micellar Formulation of Silymarin (Milk Thistle) with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial Abstract Background: Silymarin, a flavonoid complex, and the main bioactive component of milk thistle ( Silybum marianum ), is known for its hepatoprotective properties but suffers f...
PMC4878769
core_pubmed_pmc
In Vivo Pharmacokinetics/Pharmacodynamics of Cefquinome in an Experimental Mouse Model of Staphylococcus Aureus Mastitis following Intramammary Infusion
In Vivo Pharmacokinetics/Pharmacodynamics of Cefquinome in an Experimental Mouse Model of Staphylococcus Aureus Mastitis following Intramammary Infusion Abstract Abstract Staphylococcus aureus remains the major cause of morbidity of bovine mastitis worldwide leading to massive economic losses. Cefquinome is a fourth ge...
PMC6348630
core_pubmed_pmc
A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE)
A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE) Abstract Background Enadenotucirev is a chimeric adenovirus with demonstrated preclinical tumor-selective cytotoxicity and a short half-life. Further clinical mechanis...
PMC7334312
core_pubmed_pmc
A Two-Dose Oritavancin Regimen Using Pharmacokinetic Estimation Analysis
A Two-Dose Oritavancin Regimen Using Pharmacokinetic Estimation Analysis Abstract Abstract Background Antibiotics for the treatment of complicated, multidrug-resistant Gram-positive infections are limited, especially when prolonged treatment is necessary. Oritavancin is approved for the treatment of serious skin infect...
PMC12433887
core_pubmed_pmc
Evaluation of anti-liver cancer activity and anticancer mechanism of one novel small molecule compound (THY-10A62) targeting FAK pathway
Evaluation of anti-liver cancer activity and anticancer mechanism of one novel small molecule compound (THY-10A62) targeting FAK pathway Abstract Abstract Introduction Focal adhesion kinase (FAK) is a promising therapeutic target, and its aberrant overexpression has been implicated in the growth and metastasis of multi...
PMC3875564
core_pubmed_pmc
Quantitative Analysis of Microbicide Concentrations in Fluids, Gels and Tissues Using Confocal Raman Spectroscopy
Quantitative Analysis of Microbicide Concentrations in Fluids, Gels and Tissues Using Confocal Raman Spectroscopy Abstract Abstract Topical vaginal anti-HIV microbicides are an important focus in female-based strategies to prevent the sexual transmission of HIV. Understanding microbicide pharmacokinetics is essential t...
PMC4777251
core_pubmed_pmc
Bioequivalence of saxagliptin/dapagliflozin fixed‐dose combination tablets compared with coadministration of the individual tablets to healthy subjects
Bioequivalence of saxagliptin/dapagliflozin fixed‐dose combination tablets compared with coadministration of the individual tablets to healthy subjects Abstract Abstract Saxagliptin and dapagliflozin are individually indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes...
PMC4076806
core_pubmed_pmc
A Bayesian Perspective on Estimation of Variability and Uncertainty in Mechanism-Based Models
A Bayesian Perspective on Estimation of Variability and Uncertainty in Mechanism-Based Models Abstract Abstract Mechanism-based pharmacokinetic/pharmacodynamic models have a fundamental basis in biology and pharmacology and, thus, are useful for hypothesis generation and extrapolation beyond the conditions of the origi...
PMC12596893
core_pubmed_pmc
Pharmacogenetics in Tuberculosis-HIV Coinfected Populations: A Systematic Review of Genetic Variants Influencing Antiretroviral and Anti-Tuberculosis Drug Response
Pharmacogenetics in Tuberculosis-HIV Coinfected Populations: A Systematic Review of Genetic Variants Influencing Antiretroviral and Anti-Tuberculosis Drug Response Abstract Abstract Pharmacogenetics is a concept designed to tailor medication based on genetic profile to improve efficacy and reduce adverse effects. This ...
PMC10921286
core_pubmed_pmc
Keep in mind sex differences when prescribing psychotropic drugs
Keep in mind sex differences when prescribing psychotropic drugs Abstract Abstract Women represent the majority of patients with psychiatric diagnoses and also the largest users of psychotropic drugs. There are inevitable differences in efficacy, side effects and long-term treatment response between men and women. Psyc...
PMC11786465
core_pubmed_pmc
How to improve the quality of euglycemic glucose clamp tests in long-acting insulin studies
How to improve the quality of euglycemic glucose clamp tests in long-acting insulin studies Abstract Background The euglycemic clamp test stands as the best method for assessing the pharmacokinetic and pharmacodynamic properties of long-acting insulin. However, despite its widespread use, there remains a notable absenc...
PMC6076366
core_pubmed_pmc
Intranasal rifampicin for Alzheimer's disease prevention
Intranasal rifampicin for Alzheimer's disease prevention Abstract Abstract Introduction Oral rifampicin has been shown to significantly reduce amyloid β (Aβ) and tau pathologies in mice. However, it shows occasional adverse effects such as liver injury in humans, making its use difficult for a long period. Methods To e...
PMC9857140
core_pubmed_pmc
Hemodialysis as emergency treatment of a severe baclofen intoxication in a 3 kg dog
Hemodialysis as emergency treatment of a severe baclofen intoxication in a 3 kg dog Abstract Abstract Objective To describe the clinical efficacy and drug removal kinetics of hemodialysis (HD) as emergency treatment in a small size dog with severe baclofen intoxication. Case description A 2‐year‐old dog was presented i...
PMC6794948
core_pubmed_pmc
CSF1R inhibitor JNJ-40346527 attenuates microglial proliferation and neurodegeneration in P301S mice
CSF1R inhibitor JNJ-40346527 attenuates microglial proliferation and neurodegeneration in P301S mice Abstract Abstract Neuroinflammation and microglial activation are significant processes in Alzheimer’s disease pathology. Recent genome-wide association studies have highlighted multiple immune-related genes in associat...
PMC5697013
core_pubmed_pmc
Development and Qualification of Physiologically Based Pharmacokinetic Models for Drugs With Atypical Distribution Behavior: A Desipramine Case Study
Development and Qualification of Physiologically Based Pharmacokinetic Models for Drugs With Atypical Distribution Behavior: A Desipramine Case Study Abstract Abstract Desipramine is a secondary tricyclic amine, which is primarily metabolized by cytochrome 2D6. It shows a high volume of distribution (Vss) (10–50 L/kg) ...
PMC12433207
core_pubmed_pmc
Role of Radioiodine in Cancer Therapy: A Review of the Design and Challenges in Selecting Radioligands from Natural Sources
Role of Radioiodine in Cancer Therapy: A Review of the Design and Challenges in Selecting Radioligands from Natural Sources Abstract Abstract The use of radioactive isotopes in cancer treatment has marked a pivotal shift in modern medicine, where precise diagnosis and targeted therapy now blend to offer patients more e...
PMC7572575
core_pubmed_pmc
The Microbiome and the Gut‐Liver‐Brain Axis for Central Nervous System Clinical Pharmacology: Challenges in Specifying and Integrating In Vitro and In Silico Models
The Microbiome and the Gut‐Liver‐Brain Axis for Central Nervous System Clinical Pharmacology: Challenges in Specifying and Integrating In Vitro and In Silico Models Abstract The complexity of integrating microbiota into clinical pharmacology, environmental toxicology, and opioid studies arises from bidirectional and mu...
PMC4786809
core_pubmed_pmc
Determination of cyanidin 3-glucoside in rat brain, liver and kidneys by UPLC/MS-MS and its application to a short-term pharmacokinetic study
Determination of cyanidin 3-glucoside in rat brain, liver and kidneys by UPLC/MS-MS and its application to a short-term pharmacokinetic study Abstract Anthocyanins exert neuroprotection in various in vitro and in vivo experimental models. However, no details regarding their brain-related pharmacokinetics are so far ava...
PMC5124695
core_pubmed_pmc
Clinical Evaluation of Humira ® Biosimilar ONS-3010 in Healthy Volunteers: Focus on Pharmacokinetics and Pharmacodynamics
Clinical Evaluation of Humira ® Biosimilar ONS-3010 in Healthy Volunteers: Focus on Pharmacokinetics and Pharmacodynamics Abstract Abstract ONS-3010 is being developed by Oncobiologics Inc. (Cranbury, NJ, USA) as a biosimilar of Humira ® . This randomized, double blind, single-center phase I study (EudraCT registration...
PMC12072017
core_pubmed_pmc
Absorption Patterns of Fucoidan Oligosaccharides from Kjellmaniella crassifolia in the Caco-2 Monolayer Cell Model and Their Pharmacokinetics in Mice
Absorption Patterns of Fucoidan Oligosaccharides from Kjellmaniella crassifolia in the Caco-2 Monolayer Cell Model and Their Pharmacokinetics in Mice Abstract Oligosaccharides possess characteristics such as low molecular weight, good solubility, and high bioavailability, which make them better absorbed than fucoidan. ...
PMC11324966
core_pubmed_pmc
Mini review advantages and limitations of lytic phages compared with chemical antibiotics to combat bacterial infections
Mini review advantages and limitations of lytic phages compared with chemical antibiotics to combat bacterial infections Abstract The overuse of antibiotics has caused the emergence of antibiotic-resistant strains, such as multidrug-resistant, extensively drug-resistant, and pandrug-resistant bacteria. The treatment of...
PMC11475554
core_pubmed_pmc
Gender-Specific Prognostic Impact of Treosulfan Levels in High-Dose Chemotherapy for Multiple Myeloma
Gender-Specific Prognostic Impact of Treosulfan Levels in High-Dose Chemotherapy for Multiple Myeloma Abstract Simple Summary High-dose chemotherapy (HDCT) with autologous stem cell transplantation (ASCT) is a standard treatment for multiple myeloma (MM). This study examines gender-specific differences in response to t...
PMC3356170
core_pubmed_pmc
Pharmacokinetics, tissue distribution, and metabolites of a polyvinylpyrrolidone-coated norcantharidin chitosan nanoparticle formulation in rats and mice, using LC-MS/MS
Pharmacokinetics, tissue distribution, and metabolites of a polyvinylpyrrolidone-coated norcantharidin chitosan nanoparticle formulation in rats and mice, using LC-MS/MS Abstract A novel formulation containing polyvinylpyrrolidone (PVP) K 30 -coated norcantharidin (NCTD) chitosan nanoparticles (PVP–NCTD–NPs) was prepar...
PMC8246815
core_pubmed_pmc
Pharmacokinetics of Deutetrabenazine and Tetrabenazine: Dose Proportionality and Food Effect
Pharmacokinetics of Deutetrabenazine and Tetrabenazine: Dose Proportionality and Food Effect Abstract Abstract Deutetrabenazine (Austedo, Teva), an approved treatment of chorea in Huntington's disease and tardive dyskinesia in adult patients, is a rationally designed deuterated form of tetrabenazine. Two studies assess...
PMC7429772
core_pubmed_pmc
Preclinical study of simultaneous pharmacokinetic and pharmacodynamic herb-drug interactions between Yin-Chen-Hao-Tang and spironolactone
Preclinical study of simultaneous pharmacokinetic and pharmacodynamic herb-drug interactions between Yin-Chen-Hao-Tang and spironolactone Abstract Background The prevalence and therapeutic effects of the use of herbal remedies for chronic liver diseases make the combined administration of herbal products with conventio...
PMC11076592
core_pubmed_pmc
Characterizing the mechanism of action for mRNA therapeutics for the treatment of propionic acidemia, methylmalonic acidemia, and phenylketonuria
Characterizing the mechanism of action for mRNA therapeutics for the treatment of propionic acidemia, methylmalonic acidemia, and phenylketonuria Abstract Messenger RNA (mRNA) therapeutics delivered via lipid nanoparticles hold the potential to treat metabolic diseases caused by protein deficiency, including propionic ...
PMC7869082
core_pubmed_pmc
Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea
Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea Abstract Abstract Objective Two phase I studies of darinaparsin including Japanese and Korean patients with relapsed/refractory peripheral T-cell lymp...
PMC6092551
core_pubmed_pmc
Splice-Modulating Oligonucleotide QR-110 Restores CEP290 mRNA and Function in Human c.2991+1655A>G LCA10 Models
Splice-Modulating Oligonucleotide QR-110 Restores CEP290 mRNA and Function in Human c.2991+1655A>G LCA10 Models Abstract Abstract Leber congenital amaurosis type 10 (LCA10) is a severe inherited retinal dystrophy associated with mutations in CEP290 . The deep intronic c.2991+1655A>G mutation in CEP290 is the most commo...
PMC6858417
core_pubmed_pmc
Pharmacokinetics of Azithromycin, Levofloxacin, and Ofloxacin in Rabbit Extraocular Tissues After Ophthalmic Administration
Pharmacokinetics of Azithromycin, Levofloxacin, and Ofloxacin in Rabbit Extraocular Tissues After Ophthalmic Administration Abstract Introduction Azithromycin demonstrates high tissue distribution and prolonged elimination half-life. In this study, we monitored the pharmacokinetics of a single ophthalmic administration...
PMC9662918
core_pubmed_pmc
Overcoming Taxane Resistance: Preclinical and Phase 1 Studies of Relacorilant, a Selective Glucocorticoid Receptor Modulator, with Nab-Paclitaxel in Solid Tumors
Overcoming Taxane Resistance: Preclinical and Phase 1 Studies of Relacorilant, a Selective Glucocorticoid Receptor Modulator, with Nab-Paclitaxel in Solid Tumors Abstract Abstract Purpose: Chemotherapy resistance remains a major problem in many solid tumors, including breast, ovarian, and pancreatic cancer. Glucocortic...
PMC11657593
core_pubmed_pmc
Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study
Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study Abstract Abstract Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa‐B ligand (RANKL) for the treatment of osteoporosis and bone l...
PMC9972017
core_pubmed_pmc
A phase I trial of metformin in combination with vincristine, irinotecan, and temozolomide in children with relapsed or refractory solid and central nervous system tumors: A report from the national pediatric cancer foundation
A phase I trial of metformin in combination with vincristine, irinotecan, and temozolomide in children with relapsed or refractory solid and central nervous system tumors: A report from the national pediatric cancer foundation Abstract Abstract Background Patients with relapsed and refractory solid and central nervous ...
PMC7055956
core_pubmed_pmc
Mathematical modeling to reveal breakthrough mechanisms in the HIV Antibody Mediated Prevention (AMP) trials
Mathematical modeling to reveal breakthrough mechanisms in the HIV Antibody Mediated Prevention (AMP) trials Abstract Abstract The ongoing Antibody Mediated Prevention (AMP) trials will uncover whether passive infusion of the broadly neutralizing antibody (bNAb) VRC01 can protect against HIV acquisition. Previous stati...
PMC8643150
core_pubmed_pmc
Is the Fixed Periodic Treatment Effective for the Tumor System without Complete Information?
Is the Fixed Periodic Treatment Effective for the Tumor System without Complete Information? Abstract Objective The treatment plans designed with the guidance of the mathematical model and adaptive strategy can trap tumor subpopulations in a periodic and controllable loop. But this process requires detailed information...