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PMC11831190
core_pubmed_pmc
Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer
Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer Abstract Abstract Oraxol, a novel oral paclitaxel chemotherapy agent, has emerged as a potential alternative for treating metastatic breast cancer (MBC...
PMC10144804
core_pubmed_pmc
Behavioral, Neurochemical and Developmental Effects of Chronic Oral Methylphenidate: A Review
Behavioral, Neurochemical and Developmental Effects of Chronic Oral Methylphenidate: A Review Abstract The majority of animal studies on methylphenidate (MP) use intraperitoneal (IP) injections, subcutaneous (SC) injections, or the oral gavage route of administration. While all these methods allow for delivery of MP, i...
PMC8905690
core_pubmed_pmc
Eculizumab precision-dosing algorithm for thrombotic microangiopathy in children and young adults undergoing HSCT
Eculizumab precision-dosing algorithm for thrombotic microangiopathy in children and young adults undergoing HSCT Abstract Key Points This large study examined eculizumab PK/PD in bleeding and nonbleeding patients with TA-TMA. PK/PD model-based eculizumab dosing is needed for bleeding in TA-TMA, whereas fixed-dose regi...
PMC12691189
core_pubmed_pmc
Machine Learning-Based Algorithm for Tacrolimus Dose Optimization in Hospitalized Kidney Transplant Patients
Machine Learning-Based Algorithm for Tacrolimus Dose Optimization in Hospitalized Kidney Transplant Patients Abstract Abstract Background : Tacrolimus is a cornerstone immunosuppressant in kidney transplantation, but its narrow therapeutic index and marked inter-patient variability complicate dose optimization. Convent...
PMC7487995
core_pubmed_pmc
Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator
Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator Abstract Abstract Background Navafenterol (AZD8871) is a dual-pharmacology muscarinic antagonist β 2− agoni...
PMC7990449
core_pubmed_pmc
Effects of Helicobacter pylori on Levodopa Pharmacokinetics
Effects of Helicobacter pylori on Levodopa Pharmacokinetics Abstract Background: Infection with Helicobacter pylori seems overrepresented in Parkinson’s disease. Clinical observations suggest a suboptimal treatment effect of levodopa in Helicobacter positive patients. Objective: Describe and explain the connection betw...
PMC9692130
core_pubmed_pmc
Analysis of in vitro and in vivo metabolism of zidovudine and gemfibrozil in trans‐chromosomic mouse line expressing human UGT2 enzymes
Analysis of in vitro and in vivo metabolism of zidovudine and gemfibrozil in trans‐chromosomic mouse line expressing human UGT2 enzymes Abstract Abstract UDP‐glucuronosyltransferases (UGTs) catalyze the conjugation of various substrates with sugars. Since the UGT2 family forms a large cluster spanning 1.5 Mb, transgeni...
PMC6120116
core_pubmed_pmc
Nanoparticle-Mediated Delivery of Neuroprotective Substances for the Treatment of Diabetic Retinopathy
Nanoparticle-Mediated Delivery of Neuroprotective Substances for the Treatment of Diabetic Retinopathy Abstract Background: Diabetic retinopathy (DR) is a major complication of diabetes, characterized by extensive vascular pathology leading to vision loss. Neuronal suffering and death are also present in the diabetic r...
PMC10689590
core_pubmed_pmc
Single time point quantitation of cerebral glucose metabolism by FDG-PET without arterial sampling
Single time point quantitation of cerebral glucose metabolism by FDG-PET without arterial sampling Abstract Abstract Background Until recently, quantitation of the net influx of 2-[ 18 F]fluorodeoxyglucose (FDG) to brain ( K i ) and the cerebrometabolic rate for glucose (CMR glc ) required serial arterial blood samplin...
PMC4086096
core_pubmed_pmc
DDI-CPI , a server that predicts drug–drug interactions through implementing the chemical–protein interactome
DDI-CPI , a server that predicts drug–drug interactions through implementing the chemical–protein interactome Abstract Abstract Drug–drug interactions (DDIs) may cause serious side-effects that draw great attention from both academia and industry. Since some DDIs are mediated by unexpected drug–human protein interactio...
PMC6584248
core_pubmed_pmc
Clinical Pharmacokinetics and Pharmacodynamics of Immune Checkpoint Inhibitors
Clinical Pharmacokinetics and Pharmacodynamics of Immune Checkpoint Inhibitors Abstract Abstract Immune checkpoint inhibitors (ICIs) have demonstrated significant clinical impact in improving overall survival of several malignancies associated with poor outcomes; however, only 20–40% of patients will show long-lasting ...
PMC9938521
core_pubmed_pmc
Clinical significance of the rivaroxaban–dronedarone interaction: insights from physiologically based pharmacokinetic modelling
Clinical significance of the rivaroxaban–dronedarone interaction: insights from physiologically based pharmacokinetic modelling Abstract Abstract Patients with atrial fibrillation may require rhythm control therapy in addition to anticoagulation therapy for the prevention of stroke. Since 2012, the European Society of ...
PMC5317268
core_pubmed_pmc
An in vivo mechanism for the reduced peripheral neurotoxicity of NK105: a paclitaxel-incorporating polymeric micellar nanoparticle formulation
An in vivo mechanism for the reduced peripheral neurotoxicity of NK105: a paclitaxel-incorporating polymeric micellar nanoparticle formulation Abstract In our previous rodent studies, the paclitaxel (PTX)-incorporating polymeric micellar nanoparticle formulation NK105 had showed significantly stronger antitumor effects...
PMC12631680
core_pubmed_pmc
Pharmacokinetic Characterization of Single-Stranded DNA in Murine Models Using High-Specific-Activity 68 Ga Radiolabeling Coupled with Dynamic Positron Emission Tomography
Pharmacokinetic Characterization of Single-Stranded DNA in Murine Models Using High-Specific-Activity 68 Ga Radiolabeling Coupled with Dynamic Positron Emission Tomography Abstract Abstract This study aimed to develop an efficient concentration methodology to enhance the specific activity of 68 Ga. By systematically op...
PMC12756206
core_pubmed_pmc
Safety, Tolerability and Pharmacokinetics of a High-Dose, Rapid-Infusion Monoclonal Antibody: Phase I Results for Intravenous Sotrovimab 3000 mg
Safety, Tolerability and Pharmacokinetics of a High-Dose, Rapid-Infusion Monoclonal Antibody: Phase I Results for Intravenous Sotrovimab 3000 mg Abstract Background and Objectives The emergence of severe acute respiratory syndrome coronavirus 2 variants against which sotrovimab has lower in vitro neutralisation activit...
PMC4387274
core_pubmed_pmc
A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors
A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors Abstract Summary Purpose BI 831266 is a potent, selective, low-molecular-weight inhibitor of Aurora kinase B. This trial aimed to determine the maximum tolerated dose (MTD) of BI 831266 in patients with...
PMC5002098
core_pubmed_pmc
Evaluation of high-dose rifampin in patients with new, smear-positive tuberculosis (HIRIF): study protocol for a randomized controlled trial
Evaluation of high-dose rifampin in patients with new, smear-positive tuberculosis (HIRIF): study protocol for a randomized controlled trial Abstract Background Evidence has existed for decades that higher doses of rifampin may be more effective, but potentially more toxic, than standard doses used in tuberculosis trea...
PMC7187331
core_pubmed_pmc
Pharmacokinetics of Patisiran, the First Approved RNA Interference Therapy in Patients With Hereditary Transthyretin‐Mediated Amyloidosis
Pharmacokinetics of Patisiran, the First Approved RNA Interference Therapy in Patients With Hereditary Transthyretin‐Mediated Amyloidosis Abstract Abstract Hereditary transthyretin‐mediated (hATTR) amyloidosis is a rare, inherited, progressively debilitating, and often fatal disease caused by deposition of mutated tran...
PMC4706279
core_pubmed_pmc
Pharmacokinetic Interactions for Drugs with a Long Half-Life—Evidence for the Need of Model-Based Analysis
Pharmacokinetic Interactions for Drugs with a Long Half-Life—Evidence for the Need of Model-Based Analysis Abstract Pharmacokinetic drug-drug interactions (DDIs) can lead to undesired drug exposure, resulting in insufficient efficacy or aggravated toxicity. Accurate quantification of DDIs is therefore crucial but may b...
PMC6541859
core_pubmed_pmc
Pharmacokinetics of intravenous and intramuscular danofloxacin in red-eared slider turtles ( Trachemys scripta elegans )
Pharmacokinetics of intravenous and intramuscular danofloxacin in red-eared slider turtles ( Trachemys scripta elegans ) Abstract This study aimed to investigate the pharmacokinetics of danofloxacin in red-eared slider turtle ( Trachemys scripta elegans ) following a single intravenous (IV) and intramuscular (IM) admin...
PMC6373389
core_pubmed_pmc
The Role of Fluoroquinolones in the Treatment of Tuberculosis in 2019
The Role of Fluoroquinolones in the Treatment of Tuberculosis in 2019 Abstract The inability to use powerful antituberculosis drugs in an increasing number of patients seems to be the biggest threat towards global tuberculosis (TB) elimination. Simplified, shorter and preferably less toxic drug regimens are being inves...
PMC12299613
core_pubmed_pmc
Discrepancies in Recommendations on Pharmacokinetic Drug Interactions for Anticancer Medications and Direct Oral Anticoagulants (DOAC): A Comparative Analysis of Different Clinical Decision Support Systems and Sources
Discrepancies in Recommendations on Pharmacokinetic Drug Interactions for Anticancer Medications and Direct Oral Anticoagulants (DOAC): A Comparative Analysis of Different Clinical Decision Support Systems and Sources Abstract Background/objectives: In some cases of concomitant use of direct oral anticoagulants (DOAC) ...
PMC8586700
core_pubmed_pmc
Comparing the Effect of Piperine and Ilepcimide on the Pharmacokinetics of Curcumin in SD Rats
Comparing the Effect of Piperine and Ilepcimide on the Pharmacokinetics of Curcumin in SD Rats Abstract The poor bioavailability and rapid metabolism of curcumin (CUR) restrict its clinical application. Piperine (PIP), which was extracted from natural compounds, can increase the plasma concentration of curcumin in huma...
PMC12875155
core_pubmed_pmc
Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open‐Label, Parallel‐Group Study
Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open‐Label, Parallel‐Group Study Abstract Abstract ABP 654, a biosimilar to ustekinumab reference product, is available in a prefilled syringe (P...
PMC4984914
core_pubmed_pmc
Mipsagargin, a novel thapsigargin-based PSMA-activated prodrug: results of a first-in-man phase I clinical trial in patients with refractory, advanced or metastatic solid tumours
Mipsagargin, a novel thapsigargin-based PSMA-activated prodrug: results of a first-in-man phase I clinical trial in patients with refractory, advanced or metastatic solid tumours Abstract Abstract Background: Mipsagargin (G-202; (8- O -(12-aminododecanoyl)-8- O -debutanoyl thapsigargin)-Asp- γ -Glu- γ -Glu- γ -GluGluOH...
PMC12518216
core_pubmed_pmc
Decoding the EPAR scientific assessment for clinical practice: a tutorial using tislelizumab in NSCLC
Decoding the EPAR scientific assessment for clinical practice: a tutorial using tislelizumab in NSCLC Abstract Abstract European Public Assessment Reports (EPARs) are among the most scientifically rigorous sources available for evaluating newly approved oncology therapeutics, yet their complexity often limits clinical ...
PMC12567244
core_pubmed_pmc
Innovative Amino-Functionalization of Pyrido[2,3- d ]pyrimidine Scaffolds for Broad Therapeutic Applications Supported by Computational Analyses
Innovative Amino-Functionalization of Pyrido[2,3- d ]pyrimidine Scaffolds for Broad Therapeutic Applications Supported by Computational Analyses Abstract Abstract Background: Derivatives of Pyrido[2,3- d ]pyrimidine-6-carboxylate are promising multi-target scaffolds. This study focused on synthesizing 16 amino-function...
PMC6018888
core_pubmed_pmc
Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy Japanese and non-Asian male subjects
Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy Japanese and non-Asian male subjects Abstract Purpose Verinurad (RDEA3170) is a selective uric acid reabsorption inhibitor in clinical development for treatment of gout and asymptomatic hyperurice...
PMC10830790
core_pubmed_pmc
Imperatorin interacts additively with novel antiseizure medications in the mouse maximal electroshock-induced seizure model: an isobolographic transformation
Imperatorin interacts additively with novel antiseizure medications in the mouse maximal electroshock-induced seizure model: an isobolographic transformation Abstract Abstract Background Anticonvulsant effects of imperatorin (IMP) have been experimentally confirmed earlier, but no information is available on the intera...
PMC6278385
core_pubmed_pmc
Preclinical Pharmacokinetics of C118P, a Novel Prodrug of Microtubules Inhibitor and Its Metabolite C118 in Mice, Rats, and Dogs
Preclinical Pharmacokinetics of C118P, a Novel Prodrug of Microtubules Inhibitor and Its Metabolite C118 in Mice, Rats, and Dogs Abstract Abstract C118P, a phosphate prodrug of C118, which is a novel microtubule protein inhibitor, is currently under Phase I clinical development in China for treating ovarian cancer and ...
PMC7533260
core_pubmed_pmc
Design and tests of prospective property predictions for novel antimalarial 2-aminopropylaminoquinolones
Design and tests of prospective property predictions for novel antimalarial 2-aminopropylaminoquinolones Abstract Abstract There is a pressing need to improve the efficiency of drug development, and nowhere is that need more clear than in the case of neglected diseases like malaria. The peculiarities of pyrimidine meta...
PMC12196403
core_pubmed_pmc
Thermosensitive Mucoadhesive Intranasal In Situ Gel of Risperidone for Nose-to-Brain Targeting: Physiochemical and Pharmacokinetics Study
Thermosensitive Mucoadhesive Intranasal In Situ Gel of Risperidone for Nose-to-Brain Targeting: Physiochemical and Pharmacokinetics Study Abstract Background/Objectives: Non-invasive central nervous system (CNS) therapies are limited by complex mechanisms and the blood–brain barrier, but nasal delivery offers a promisi...
PMC12217487
core_pubmed_pmc
Evaluating tigecycline dosing for hospital-acquired pneumonia patients: insights from physiologically-based pharmacokinetic modeling of lung exposure
Evaluating tigecycline dosing for hospital-acquired pneumonia patients: insights from physiologically-based pharmacokinetic modeling of lung exposure Abstract ABSTRACT Tigecycline is increasingly used off-label for hospital-acquired pneumonia (HAP), though its efficacy and optimal dosing remain uncertain. Lung exposure...
PMC12621185
core_pubmed_pmc
Design, Syntheses, and Pharmacological Evaluations of Core Ring Expanded Fentanyl Analogues as Potential Counteracting Agents Against Fentanyl Induced Respiratory Depression
Design, Syntheses, and Pharmacological Evaluations of Core Ring Expanded Fentanyl Analogues as Potential Counteracting Agents Against Fentanyl Induced Respiratory Depression Abstract Abstract The escalating synthetic opioid crisis necessitates novel treatments, especially for fentanyl overdose. This study presents 84 r...
PMC11124240
core_pubmed_pmc
In Silico Design of Potential Small-Molecule Antibiotic Adjuvants against Salmonella typhimurium Ortho Acetyl Sulphydrylase Synthase to Address Antimicrobial Resistance
In Silico Design of Potential Small-Molecule Antibiotic Adjuvants against Salmonella typhimurium Ortho Acetyl Sulphydrylase Synthase to Address Antimicrobial Resistance Abstract Abstract The inhibition of O -acetyl sulphydrylase synthase isoforms has been reported to represent a promising approach for the development o...
PMC7039713
core_pubmed_pmc
Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods
Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods Abstract Abstract Asthma causes enormous suffering and cost for children in the US and around the world [ , , ]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more ...
PMC9103378
core_pubmed_pmc
Unraveling enhanced brain delivery of paliperidone-loaded lipid nanoconstructs: pharmacokinetic, behavioral, biochemical, and histological aspects
Unraveling enhanced brain delivery of paliperidone-loaded lipid nanoconstructs: pharmacokinetic, behavioral, biochemical, and histological aspects Abstract Abstract Antipsychotics are accompanied by extrapyramidal side effects that deter treatment adherence and patient compliance. Paliperidone (PPD), an atypical (secon...
PMC11727040
core_pubmed_pmc
Monophosphate Derivatives of Luteolin and Apigenin as Efficient Precursors with Improved Oral Bioavailability in Rats
Monophosphate Derivatives of Luteolin and Apigenin as Efficient Precursors with Improved Oral Bioavailability in Rats Abstract Luteolin (Lut) and apigenin (Apn), flavones present in various edible plants, exhibit diverse antioxidant and pharmacological activities but have limited in vivo efficacy due to low water solub...
PMC3910009
core_pubmed_pmc
Use of a Population Pharmacokinetic Approach for the Clinical Development of a Fixed-Dose Subcutaneous Formulation of Trastuzumab
Use of a Population Pharmacokinetic Approach for the Clinical Development of a Fixed-Dose Subcutaneous Formulation of Trastuzumab Abstract A new subcutaneous (s.c.) trastuzumab formulation provides savings in terms of time and is preferred by patients and health care professionals relative to standard intravenous (i.v....
PMC10347189
core_pubmed_pmc
Amelioration of Cancer Employing Chitosan, Its Derivatives, and Chitosan-Based Nanoparticles: Recent Updates
Amelioration of Cancer Employing Chitosan, Its Derivatives, and Chitosan-Based Nanoparticles: Recent Updates Abstract The limitations associated with the conventional treatment of cancer have necessitated the design and development of novel drug delivery systems based mainly on nanotechnology. These novel drug delivery...
PMC4636169
core_pubmed_pmc
Nanoencapsulation of natural triterpenoid celastrol for prostate cancer treatment
Nanoencapsulation of natural triterpenoid celastrol for prostate cancer treatment Abstract Celastrol (CL), a triterpenoid extracted from the Chinese herb Tripterygium wilfordii , has recently attracted interest for its potential antitumor effects. However, unfavorable physicochemical and pharmacokinetics properties suc...
PMC11117356
core_pubmed_pmc
Meropenem Disposition in Neonatal and Pediatric Extracorporeal Membrane Oxygenation and Continuous Renal Replacement Therapy
Meropenem Disposition in Neonatal and Pediatric Extracorporeal Membrane Oxygenation and Continuous Renal Replacement Therapy Abstract Abstract This study aimed to characterize the impact of extracorporeal membrane oxygenation (ECMO) on the pharmacokinetics (PK) of meropenem in neonates and children and to provide recom...
PMC4921118
core_pubmed_pmc
Everolimus pharmacokinetics and its exposure–toxicity relationship in patients with thyroid cancer
Everolimus pharmacokinetics and its exposure–toxicity relationship in patients with thyroid cancer Abstract Background Everolimus is a mTOR inhibitor used for the treatment of different solid malignancies. Many patients treated with the registered fixed 10 mg dose once daily are in need of dose interruptions, reduction...
PMC7338825
core_pubmed_pmc
Effect of food on the pharmacokinetics of the WEE1 inhibitor adavosertib (AZD1775) in patients with advanced solid tumors
Effect of food on the pharmacokinetics of the WEE1 inhibitor adavosertib (AZD1775) in patients with advanced solid tumors Abstract Purpose To support future dosing recommendations, the effect of food on the pharmacokinetics of adavosertib, a first-in-class, small-molecule reversible inhibitor of WEE1 kinase, was assess...
PMC11269472
core_pubmed_pmc
Stimulus mediation, specificity and impact of menthol in rats trained to discriminate puffs of nicotine e-cigarette aerosol from nicotine-free aerosol
Stimulus mediation, specificity and impact of menthol in rats trained to discriminate puffs of nicotine e-cigarette aerosol from nicotine-free aerosol Abstract Abstract Rationale It is unclear if e-cigarettes have reduced abuse liability relative to traditional cigarettes, especially when considering advanced devices w...
PMC7125811
core_pubmed_pmc
Evaluation of potential herb-drug interactions between oseltamivir and commonly used anti-influenza Chinese medicinal herbs
Evaluation of potential herb-drug interactions between oseltamivir and commonly used anti-influenza Chinese medicinal herbs Abstract Ethnopharmacological relevance According to Traditional Chinese Medicine theory, influenza is categorized as a warm disease or Wen Bing. The Wen Bing formulas, such as Yin-Qiao-San and Sa...
PMC5785470
core_pubmed_pmc
Characterization of Nanodiamond-based anti-HIV drug Delivery to the Brain
Characterization of Nanodiamond-based anti-HIV drug Delivery to the Brain Abstract Human Immunodeficiency Virus Type 1 (HIV-1) remains one of the leading causes of death worldwide. Present combination antiretroviral therapy has substantially improved HIV-1 related pathology. However, delivery of therapeutic agents to t...
PMC9305536
core_pubmed_pmc
Decreased isavuconazole trough concentrations in the treatment of invasive aspergillosis in an adult patient receiving extracorporeal membrane oxygenation support
Decreased isavuconazole trough concentrations in the treatment of invasive aspergillosis in an adult patient receiving extracorporeal membrane oxygenation support Abstract Abstract Purpose We present the case of a 56-year-old man with stage IV sarcoidosis on veno-venous extracorporeal membrane oxygenation (VV-ECMO) sup...
PMC6231440
core_pubmed_pmc
In vitro and in vivo quantification of chloroprocaine release from an implantable device in a piglet postoperative pain model
In vitro and in vivo quantification of chloroprocaine release from an implantable device in a piglet postoperative pain model Abstract Abstract Background The pharmacokinetic properties and clinical advantages of the local anesthetic chloroprocaine are well known. Here, we studied the pharmacokinetic profile of a new h...
PMC9291816
core_pubmed_pmc
Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy
Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy Abstract Abstract Risdiplam (Evrysdi) improves motor neuron function in patients with spinal muscular atrophy (SMA) and has been approved for the treatment of patients ≥2 months...
PMC8726733
core_pubmed_pmc
Development of a fully canine anti-canine CTLA4 monoclonal antibody for comparative translational research in dogs with spontaneous tumors
Development of a fully canine anti-canine CTLA4 monoclonal antibody for comparative translational research in dogs with spontaneous tumors Abstract ABSTRACT The immune checkpoint inhibitor (ICI) ipilimumab has revolutionized the treatment of patients with different cancer histologies, including melanoma, renal cell car...
PMC5078031
core_pubmed_pmc
Phase I clinical study of RG7356, an anti-CD44 humanized antibody, in patients with acute myeloid leukemia
Phase I clinical study of RG7356, an anti-CD44 humanized antibody, in patients with acute myeloid leukemia Abstract Abstract RG7356, a recombinant anti-CD44 immunoglobulin G1 humanized monoclonal antibody, inhibits cell adhesion and has been associated with macrophage activation in preclinical models. We report results...
PMC10220852
core_pubmed_pmc
Exposure–Response Analysis of the Sodium–Glucose Cotransporter-2 Inhibitors Dapagliflozin and Empagliflozin on Kidney Hemodynamics in Patients with Type 2 Diabetes
Exposure–Response Analysis of the Sodium–Glucose Cotransporter-2 Inhibitors Dapagliflozin and Empagliflozin on Kidney Hemodynamics in Patients with Type 2 Diabetes Abstract Abstract Sodium–glucose cotransporter-2 (SGLT2) inhibitors improve markers for renal and cardiovascular outcomes in patients with and without type ...
PMC3064895
core_pubmed_pmc
A phase I open-label study evaluating the cardiovascular safety of sorafenib in patients with advanced cancer
A phase I open-label study evaluating the cardiovascular safety of sorafenib in patients with advanced cancer Abstract Purpose To characterize the cardiovascular profile of sorafenib, a multitargeted kinase inhibitor, in patients with advanced cancer. Methods Fifty-three patients with advanced cancer received oral sora...
PMC5649121
core_pubmed_pmc
Lack of QT Prolongation for 2′- O -Methoxyethyl-Modified Antisense Oligonucleotides Based on Retrospective Exposure/Response Analysis of Ten Phase 1 Dose-Escalation Placebo-Controlled Studies in Healthy Subjects
Lack of QT Prolongation for 2′- O -Methoxyethyl-Modified Antisense Oligonucleotides Based on Retrospective Exposure/Response Analysis of Ten Phase 1 Dose-Escalation Placebo-Controlled Studies in Healthy Subjects Abstract The potential of QT prolongation of ten 2′- O -methoxyethyl-modified (2′-MOE) antisense oligonucleo...
PMC9599532
core_pubmed_pmc
PHLPP Inhibitor NSC74429 Is Neuroprotective in Rodent Models of Cardiac Arrest and Traumatic Brain Injury
PHLPP Inhibitor NSC74429 Is Neuroprotective in Rodent Models of Cardiac Arrest and Traumatic Brain Injury Abstract Pleckstrin homology domain and leucine rich repeat protein phosphatase (PHLPP) knockout mice have improved outcomes after a stroke, traumatic brain injury (TBI), and decreased maladaptive vascular remodeli...
PMC7830329
core_pubmed_pmc
Complex Factors and Challenges that Affect the Pharmacology, Safety and Efficacy of Nanocarrier Drug Delivery Systems
Complex Factors and Challenges that Affect the Pharmacology, Safety and Efficacy of Nanocarrier Drug Delivery Systems Abstract Abstract Major developments in nanomedicines, such as nanoparticles (NPs), nanosomes, and conjugates, have revolutionized drug delivery capabilities over the past four decades. Although nanocar...
PMC5818482
core_pubmed_pmc
Experimental study of the anti-tumour activity and pharmacokinetics of arctigenin and its valine ester derivative
Experimental study of the anti-tumour activity and pharmacokinetics of arctigenin and its valine ester derivative Abstract Arctigenin (ARG) is a functional active component that has important physiological and pharmacological activities. The anti-tumour and anti-inflammatory activities of ARG show good potential for ap...
PMC4612330
core_pubmed_pmc
A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC)
A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC) Abstract Abstact Introduction Veliparib is a potent, orally bioavailable PARP inhibitor that enhances efficacy of DNA-da...
PMC8779255
core_pubmed_pmc
Determining the Anticancer Activity of Sphingosine Kinase Inhibitors Containing Heteroatoms in Their Tail Structure
Determining the Anticancer Activity of Sphingosine Kinase Inhibitors Containing Heteroatoms in Their Tail Structure Abstract Abstract Sphingosine kinase (SK) enzyme, a central player of sphingolipid rheostat, catalyzes the phosphorylation of sphingosine to the bioactive lipid mediator sphingosine 1 phosphate (S1P), whi...
PMC11255394
core_pubmed_pmc
Piperacillin/tazobactam treatment in children: evidence of subtherapeutic concentrations
Piperacillin/tazobactam treatment in children: evidence of subtherapeutic concentrations Abstract Abstract Objective Piperacillin/tazobactam (PIP/TAZ) is used for the treatment of lower respiratory tract bacterial infections in children. This study was performed to evaluate if the current dosing regimen results in ther...
PMC7693160
core_pubmed_pmc
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen Abstract Abstract Physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models can serve as a powerfu...
PMC8621408
core_pubmed_pmc
Absorption of N-acetylcysteine in Healthy and Mycoplasma gallisepticum -Infected Chickens
Absorption of N-acetylcysteine in Healthy and Mycoplasma gallisepticum -Infected Chickens Abstract Abstract N-acetylcysteine (NAC) is widely used as a mucolytic agent in cases with inflammation of the lungs. NAC is applied in poultry with aflatoxin B1 intoxication as an antioxidant, but its pharmacokinetics are not kno...
PMC10542238
core_pubmed_pmc
A field bioassay for assessing ivermectin bio-efficacy in wild malaria vectors
A field bioassay for assessing ivermectin bio-efficacy in wild malaria vectors Abstract Abstract Background Ivermectin (IVM) mass drug administration is a candidate complementary malaria vector control tool. Ingestion of blood from IVM treated hosts results in reduced survival in mosquitoes. Estimating bio-efficacy of ...
PMC3765993
core_pubmed_pmc
The duration of sleep promoting efficacy by dual orexin receptor antagonists is dependent upon receptor occupancy threshold
The duration of sleep promoting efficacy by dual orexin receptor antagonists is dependent upon receptor occupancy threshold Abstract Background Drugs targeting insomnia ideally promote sleep throughout the night, maintain normal sleep architecture, and are devoid of residual effects associated with morning sedation. Th...
PMC10133580
core_pubmed_pmc
Computational pharmacology and computational chemistry of 4-hydroxyisoleucine: Physicochemical, pharmacokinetic, and DFT-based approaches
Computational pharmacology and computational chemistry of 4-hydroxyisoleucine: Physicochemical, pharmacokinetic, and DFT-based approaches Abstract Abstract Computational pharmacology and chemistry of drug-like properties along with pharmacokinetic studies have made it more amenable to decide or predict a potential drug...
PMC8190023
core_pubmed_pmc
Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation
Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation Abstract Introduction Lubiprostone capsules are approved for managing three different chronic constipation conditions. A “sprinkle” formulation may facilitate use in individuals with difficulty swallo...
PMC8716378
core_pubmed_pmc
Radiolabeled Monoclonal Antibody Against Colony-Stimulating Factor 1 Receptor Specifically Distributes to the Spleen and Liver in Immunocompetent Mice
Radiolabeled Monoclonal Antibody Against Colony-Stimulating Factor 1 Receptor Specifically Distributes to the Spleen and Liver in Immunocompetent Mice Abstract Macrophages can promote tumor development. Preclinically, targeting macrophages by colony-stimulating factor 1 (CSF1)/CSF1 receptor (CSF1R) monoclonal antibodie...
PMC5963635
core_pubmed_pmc
Ocular Distribution and Pharmacokinetics of Lifitegrast in Pigmented Rabbits and Mass Balance in Beagle Dogs
Ocular Distribution and Pharmacokinetics of Lifitegrast in Pigmented Rabbits and Mass Balance in Beagle Dogs Abstract Abstract Purpose: Lifitegrast is approved in the United States for the treatment of dry eye disease (DED). We assessed lifitegrast's ocular distribution/pharmacokinetic profile in rabbits, and 14 C-lifi...
PMC10100048
core_pubmed_pmc
Acetaminophen pharmacokinetics in infants and children with congenital heart disease
Acetaminophen pharmacokinetics in infants and children with congenital heart disease Abstract Abstract Background Acetaminophen is routinely used for perioperative analgesia in children undergoing major surgical procedures. There are few estimates of acetaminophen pharmacokinetic parameters in children with congenital ...
PMC6437720
core_pubmed_pmc
Introduction of the YTE mutation into the non-immunogenic HIV bnAb PGT121 induces anti-drug antibodies in macaques
Introduction of the YTE mutation into the non-immunogenic HIV bnAb PGT121 induces anti-drug antibodies in macaques Abstract Recombinant antibodies play increasingly important roles as immunotherapeutic treatments for human cancers as well as inflammatory and infectious diseases and have revolutionized their management....
PMC11169020
core_pubmed_pmc
In vitro to in vivo extrapolation to derive a metabolism factor for estimating the aggregate exposure to salicylic acid after dermal exposure of its esters
In vitro to in vivo extrapolation to derive a metabolism factor for estimating the aggregate exposure to salicylic acid after dermal exposure of its esters Abstract As part of the safety assessment of salicylate esters in cosmetics, we developed a metabolism factor based on in vitro to in vivo extrapolation (IVIVE) to ...
PMC7497411
core_pubmed_pmc
Applications of the microphysiology systems database for experimental ADME-Tox and disease models †
Applications of the microphysiology systems database for experimental ADME-Tox and disease models † Abstract The Microphysiology Systems Database (MPS) is a critical tool for the design, management, analysis, and sharing of MPS study data. Abstract To accelerate the development and application of Microphysiological Sys...
PMC6955637
core_pubmed_pmc
Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects
Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects Abstract Purpose SB4 is an etanercept biosimilar, approved by the European Commission (EC) and the US Food and Drug Administration (FDA) following a demonstration of equivalent e...
PMC9579388
core_pubmed_pmc
Effect of CSL112 (apolipoprotein A‐I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross‐study comparison
Effect of CSL112 (apolipoprotein A‐I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross‐study comparison Abstract Abstract CSL112 (apolipoprotein A‐I [apoA‐I, human]) is a novel drug in development to reduce the risk of recurrent cardiovascular events following acute...
PMC8066515
core_pubmed_pmc
Drug-Drug Interactions Leading to Adverse Drug Reactions with Rivaroxaban: A Systematic Review of the Literature and Analysis of VigiBase
Drug-Drug Interactions Leading to Adverse Drug Reactions with Rivaroxaban: A Systematic Review of the Literature and Analysis of VigiBase Abstract Abstract Rivaroxaban has become an alternative to vitamin K antagonists, which are considered to be at higher risk of drug-drug interactions (DDI) and more difficult to use....
PMC4626400
core_pubmed_pmc
The Safety and Pharmacokinetics of Carprofen, Flunixin and Phenylbutazone in the Cape Vulture ( Gyps coprotheres ) following Oral Exposure
The Safety and Pharmacokinetics of Carprofen, Flunixin and Phenylbutazone in the Cape Vulture ( Gyps coprotheres ) following Oral Exposure Abstract The following study evaluates the overt toxic potential of carprofen (CRP), flunixin (FXN) and phenylbutazone (PBZ) in Old world vultures in relation to historic toxicity d...
PMC10494459
core_pubmed_pmc
A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects
A randomized trial comparing LY01011, biosimilar candidate, with the reference product denosumab (Xgeva®) in healthy Chinese subjects Abstract Highlights • Patients with bone metastasis from solid tumors could experience skeletal related events, which lead to impaired functional status and quality of life. • The refere...
PMC12163105
core_pubmed_pmc
Do Liposomal Vitamin C Formulations Have Improved Bioavailability? A Scoping Review Identifying Future Research Directions
Do Liposomal Vitamin C Formulations Have Improved Bioavailability? A Scoping Review Identifying Future Research Directions Abstract ABSTRACT Due to the essential requirement of vitamin C (ascorbate) by humans, formulation of the vitamin to increase its bioavailability is of relevance, particularly for those with higher...
PMC8930943
core_pubmed_pmc
The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib
The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib Abstract Background and Objective Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. To evaluate...
PMC9747129
core_pubmed_pmc
Platelet thromboxane inhibition by low‐dose aspirin in polycythemia vera: Ex vivo and in vivo measurements and in silico simulation
Platelet thromboxane inhibition by low‐dose aspirin in polycythemia vera: Ex vivo and in vivo measurements and in silico simulation Abstract Abstract Low‐dose aspirin is currently recommended for patients with polycythemia vera (PV), a myeloproliferative neoplasm with increased risk of arterial and venous thromboses. B...
PMC8491459
core_pubmed_pmc
The use of GA‐RxODE (Genetics Algorithms and Running simulations from Ordinary Differential Equations‐based model) method to optimize bioequivalence studies
The use of GA‐RxODE (Genetics Algorithms and Running simulations from Ordinary Differential Equations‐based model) method to optimize bioequivalence studies Abstract Abstract Bioequivalence (BE) studies are prerequisite in generic products approval. Normally, they are quite simple in design and expensive in execution, ...
PMC9866473
core_pubmed_pmc
Evaluation of pH-Sensitive Polymeric Micelles Using Citraconic Amide Bonds for the Co-Delivery of Paclitaxel, Etoposide, and Rapamycin
Evaluation of pH-Sensitive Polymeric Micelles Using Citraconic Amide Bonds for the Co-Delivery of Paclitaxel, Etoposide, and Rapamycin Abstract Paclitaxel (PTX), etoposide (ETP), and rapamycin (RAPA) have different mechanisms, allowing multiple pathways to be targeted simultaneously, effectively treating various cancer...
PMC10954986
core_pubmed_pmc
A Population Pharmacokinetic Analysis of l -Glutamine Exposure in Patients with Sickle Cell Disease: Evaluation of Dose and Food Effects
A Population Pharmacokinetic Analysis of l -Glutamine Exposure in Patients with Sickle Cell Disease: Evaluation of Dose and Food Effects Abstract Background and Objective l -Glutamine is a treatment for children and adults with sickle cell disease. A comprehensive evaluation of the pharmacokinetics of l -glutamine in s...
PMC8176130
core_pubmed_pmc
Pharmacokinetic and pharmacodynamic interaction of Rosuvastatin calcium with guggulipid extract in rats
Pharmacokinetic and pharmacodynamic interaction of Rosuvastatin calcium with guggulipid extract in rats Abstract Abstract Background & objectives Rosuvastatin calcium (RC) is a potent and competitive synthetic inhibitor of HMG-CoA reductase used for the treatment of dyslipidemia. Guggulipid obtained from Commiphora muk...
PMC10156102
core_pubmed_pmc
Development and application of a thin‐film molecularly imprinted polymer for the measurement of mycophenolic acid in human plasma
Development and application of a thin‐film molecularly imprinted polymer for the measurement of mycophenolic acid in human plasma Abstract Abstract Background Mycophenolic acid (MPA) is used to suppress the immune response following organ transplantation; however, complex pharmacokinetic behavior and a large interperso...
PMC12905065
core_pubmed_pmc
Recombinant von Willebrand factor for von Willebrand disease: mechanism of action and clinical application
Recombinant von Willebrand factor for von Willebrand disease: mechanism of action and clinical application Abstract Abstract Von Willebrand disease (VWD) is an inherited bleeding disorder resulting from a deficiency in von Willebrand factor (VWF), either quantitative or qualitative. Recombinant VWF (rVWF) presents a no...
PMC11988044
core_pubmed_pmc
Development and Validation of an LC–MS/MS Method for Quantifying Gabapentin in Plasma: Application to a Pharmacokinetic Study in Cats
Development and Validation of an LC–MS/MS Method for Quantifying Gabapentin in Plasma: Application to a Pharmacokinetic Study in Cats Abstract Simple Summary Gabapentin is an analogue of the neurotransmitter γ-aminobutyric acid, which is commonly used to treat neuropathic pain and epilepsy. However, studies have shown ...
PMC12571643
core_pubmed_pmc
Challenges in Extrapolating Healthy Volunteer Pharmacokinetics to Oncology Populations: Advocating for a Holistic Perspective
Challenges in Extrapolating Healthy Volunteer Pharmacokinetics to Oncology Populations: Advocating for a Holistic Perspective Abstract ABSTRACT Phase I clinical pharmacology (CP) studies in healthy volunteers (HVs) are conducted to assess factors influencing drug pharmacokinetic (PK) properties and guide potential dose...
PMC7813200
core_pubmed_pmc
A brain-penetrant microtubule-targeting agent that disrupts hallmarks of glioma tumorigenesis
A brain-penetrant microtubule-targeting agent that disrupts hallmarks of glioma tumorigenesis Abstract Abstract Background Glioma is sensitive to microtubule-targeting agents (MTAs), but most MTAs do not cross the blood brain barrier (BBB). To address this limitation, we developed the new chemical entity, ST-401, a bra...
PMC7288058
core_pubmed_pmc
Modulating the Properties of Fe(III) Macrocyclic MRI Contrast Agents by Appending Sulfonate or Hydroxyl Groups
Modulating the Properties of Fe(III) Macrocyclic MRI Contrast Agents by Appending Sulfonate or Hydroxyl Groups Abstract Abstract Complexes of Fe(III) that contain a triazacyclononane (TACN) macrocycle, two pendant hydroxyl groups, and a third ancillary pendant show promise as MRI contrast agents. The ancillary group pl...
PMC10182103
core_pubmed_pmc
Mechanistic Pharmacokinetic/Pharmacodynamic Modeling in Support of a Patient-Convenient, Longer Dosing Interval for Carfilzomib, a Covalent Inhibitor of the Proteasome
Mechanistic Pharmacokinetic/Pharmacodynamic Modeling in Support of a Patient-Convenient, Longer Dosing Interval for Carfilzomib, a Covalent Inhibitor of the Proteasome Abstract Abstract Background Carfilzomib is an irreversible second-generation proteasome inhibitor that has a short elimination half-life but much longe...
PMC9426668
core_pubmed_pmc
Pharmacokinetics, Safety and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn’s Disease: Results from the Phase 2 HUBBLE Study
Pharmacokinetics, Safety and Efficacy of Intravenous Vedolizumab in Paediatric Patients with Ulcerative Colitis or Crohn’s Disease: Results from the Phase 2 HUBBLE Study Abstract Abstract Background and Aims To date, there are no systematic pharmacokinetic [PK] data on vedolizumab in paediatric inflammatory bowel disea...
PMC7046625
core_pubmed_pmc
Pharmacokinetics of Intravenous and Oral Phenobarbital Sodium in Healthy Goats
Pharmacokinetics of Intravenous and Oral Phenobarbital Sodium in Healthy Goats Abstract Abstract Phenobarbital is a common drug used to manage epilepsy in goats. However, the recommended dose and dosing frequency are based on studies in dogs and horses. Studies describing the pharmacokinetics of phenobarbital when admi...
PMC11862783
core_pubmed_pmc
External evaluation of intravenous vancomycin population pharmacokinetic models in adults receiving high‐flux intermittent haemodialysis
External evaluation of intravenous vancomycin population pharmacokinetic models in adults receiving high‐flux intermittent haemodialysis Abstract Abstract Aims Patients undergoing haemodialysis (HD) are at greater risk of methicillin‐resistant Staphylococcus aureus infections requiring intravenous vancomycin. Close van...
PMC2941486
core_pubmed_pmc
Evidence of d -phenylglycine as delivering tool for improving l -dopa absorption
Evidence of d -phenylglycine as delivering tool for improving l -dopa absorption Abstract Background l -Dopa has been used for Parkinson's disease management for a long time. However, its wide variety in the rate and the extent of absorption remained challenge in designing suitable therapeutic regime. We report here a ...
PMC3432792
core_pubmed_pmc
Eribulin mesylate in patients with refractory cancers: a Phase I study
Eribulin mesylate in patients with refractory cancers: a Phase I study Abstract Summary Eribulin mesylate (Halaven™, E7389) is a synthetic analog of the marine natural product halichondrin B that acts via a mechanism distinct from conventional tubulin-targeted agents. This Phase I study (clinicaltrials.gov identifier: ...
PMC6600332
core_pubmed_pmc
Liquid Chromatography-Tandem Mass Spectrometry of Desoxo-Narchinol a and Its Pharmacokinetics and Oral Bioavailability in Rats and Mice
Liquid Chromatography-Tandem Mass Spectrometry of Desoxo-Narchinol a and Its Pharmacokinetics and Oral Bioavailability in Rats and Mice Abstract Desoxo-narchinol A is one of the major active constituents from Nardostachys jatamansi , which has been reported to possess various pharmacological activities, including anti-...
PMC4648969
core_pubmed_pmc
Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer
Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer Abstract Summary Background Lapatinib has proven efficacy as monotherapy and in combination with capecitabine in patients with metastatic breast cancer (MBC) overexpressing HER2 and/or EGFR. Gemcitabin...
PMC10507879
core_pubmed_pmc
Knowledge, attitude and perceptions of pharmacists regarding renal dose adjustment among chronic kidney disease patients in Pakistan
Knowledge, attitude and perceptions of pharmacists regarding renal dose adjustment among chronic kidney disease patients in Pakistan Abstract Abstract Background Chronic kidney disease (CKD) poses a significant public health challenge. CKD patients have compromised renal function, which not only alters the pharmacokine...