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PMC3787222
core_pubmed_pmc
Comparison of Methods for Handling Missing Covariate Data
Comparison of Methods for Handling Missing Covariate Data Abstract Missing covariate data is a common problem in nonlinear mixed effects modelling of clinical data. The aim of this study was to implement and compare methods for handling missing covariate data in nonlinear mixed effects modelling under different missing...
PMC10630984
core_pubmed_pmc
Prepercutaneous coronary intervention Zalunfiban dose-response relationship to target vessel blood flow at initial angiogram in st-elevation myocardial infarction – A post hoc analysis of the cel-02 phase IIa study
Prepercutaneous coronary intervention Zalunfiban dose-response relationship to target vessel blood flow at initial angiogram in st-elevation myocardial infarction – A post hoc analysis of the cel-02 phase IIa study Abstract Background Zalunfiban (RUC-4) is a novel, subcutaneously administered glycoprotein IIb/IIIa inhi...
PMC9291793
core_pubmed_pmc
Population pharmacokinetic and exposure–efficacy analysis of ixekizumab in paediatric patients with moderate‐to‐severe plaque psoriasis (IXORA‐PEDS)
Population pharmacokinetic and exposure–efficacy analysis of ixekizumab in paediatric patients with moderate‐to‐severe plaque psoriasis (IXORA‐PEDS) Abstract Aims Ixekizumab is a high‐affinity monoclonal antibody that selectively targets interleukin‐17A used in the treatment of adult and paediatric patients with modera...
PMC8846559
core_pubmed_pmc
The Evaluation of Meropenem Dosing Regimens Against ESBL-Producing Escherichia coli in ICU Patients Using Monte Carlo Simulation
The Evaluation of Meropenem Dosing Regimens Against ESBL-Producing Escherichia coli in ICU Patients Using Monte Carlo Simulation Abstract Abstract Purpose To evaluate the optimal dosing regimens of meropenem against extended-spectrum beta-lactamase-producing Escherichia coli (ESBL E. coli ) in critically ill patients w...
PMC10376274
core_pubmed_pmc
N-acetylcysteine Pharmacology and Applications in Rare Diseases—Repurposing an Old Antioxidant
N-acetylcysteine Pharmacology and Applications in Rare Diseases—Repurposing an Old Antioxidant Abstract N-acetylcysteine (NAC), a precursor of cysteine and, thereby, glutathione (GSH), acts as an antioxidant through a variety of mechanisms, including oxidant scavenging, GSH replenishment, antioxidant signaling, etc. Ow...
PMC7221031
core_pubmed_pmc
Concordance of Vancomycin Population-Predicted Pharmacokinetics with Patient-Specific Pharmacokinetics in Adult Hospitalized Patients: A Case Series
Concordance of Vancomycin Population-Predicted Pharmacokinetics with Patient-Specific Pharmacokinetics in Adult Hospitalized Patients: A Case Series Abstract Background Vancomycin empiric therapy is commonly dosed using clinical algorithms adapted from population-predicted pharmacokinetic parameters. However, precise d...
PMC12199100
core_pubmed_pmc
Investigation of a broad‐spectrum micronutrient formulation as a possible precipitant of pharmacokinetic micronutrient–drug interactions
Investigation of a broad‐spectrum micronutrient formulation as a possible precipitant of pharmacokinetic micronutrient–drug interactions Abstract Abstract Aims Daily broad‐spectrum micronutrients are being used by the general public and formulations are receiving research interest in mental health settings. Despite con...
PMC4440441
core_pubmed_pmc
A Two-Step Pretargeted Nanotherapy for CD20 Crosslinking May Achieve Superior Anti-Lymphoma Efficacy to Rituximab
A Two-Step Pretargeted Nanotherapy for CD20 Crosslinking May Achieve Superior Anti-Lymphoma Efficacy to Rituximab Abstract Abstract The use of rituximab, an anti-CD20 mAb, in combination with chemotherapy is the current standard for the treatment of B-cell lymphomas. However, because of a significant number of treatmen...
PMC10022656
core_pubmed_pmc
Breastfeeding on Injectable Opioid Agonist Therapy: A Case Report
Breastfeeding on Injectable Opioid Agonist Therapy: A Case Report Abstract Background Injectable opioid agonist therapy (iOAT) is the highest-intensity treatment currently available in Canada for individuals with severe opioid use disorder. However, there is limited data on iOAT administration in the perinatal period, ...
PMC9805203
core_pubmed_pmc
Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data
Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data Abstract Abstract Aims During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that effects are observed in blind...
PMC12587597
core_pubmed_pmc
Population pharmacokinetics and Monte Carlo-based dosing optimization of trimethoprim-sulfamethoxazole
Population pharmacokinetics and Monte Carlo-based dosing optimization of trimethoprim-sulfamethoxazole Abstract ABSTRACT This study aimed to develop population pharmacokinetic (PopPK) models for intravenous sulfamethoxazole (SMX) and trimethoprim (TMP) to optimize dosing regimens for the treatment of Pneumocystis jirov...
PMC12810954
core_pubmed_pmc
Targeted computational design of an interleukin-7 superkine with enhanced folding efficiency and immunotherapeutic efficacy
Targeted computational design of an interleukin-7 superkine with enhanced folding efficiency and immunotherapeutic efficacy Abstract Interleukin-7 (IL-7) plays a central role in maintaining T cell development and immune homeostasis, and enhancing the cytokine’s immune-stimulatory functionality has broad therapeutic imp...
PMC5811172
core_pubmed_pmc
Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines
Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines Abstract Background and objective Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstan...
PMC12845146
core_pubmed_pmc
UHPLC–Q–Orbitrap–HRMS-Based Multilayer Mapping of the Pharmacodynamic Substance Basis and Mechanistic Landscape of Maizibizi Wan in Chronic Nonbacterial Prostatitis Therapy
UHPLC–Q–Orbitrap–HRMS-Based Multilayer Mapping of the Pharmacodynamic Substance Basis and Mechanistic Landscape of Maizibizi Wan in Chronic Nonbacterial Prostatitis Therapy Abstract Background: Chronic nonbacterial prostatitis (CNP), the major subset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), impose...
PMC12779495
core_pubmed_pmc
Therapeutic Effects of Nizubaglustat in a Mouse Model of GM2 Gangliosidosis
Therapeutic Effects of Nizubaglustat in a Mouse Model of GM2 Gangliosidosis Abstract ABSTRACT Nizubaglustat is a novel selective inhibitor of glucosylceramide synthase (GCS) and the non‐lysosomal glucocerebrosidase (NLGase, GbA2) with brain penetrant properties. It is currently in clinical development as an oral treatm...
PMC8804710
core_pubmed_pmc
A very long-acting IL-15: implications for the immunotherapy of cancer
A very long-acting IL-15: implications for the immunotherapy of cancer Abstract Background Interleukin-15 (IL-15) is an important cytokine necessary for proliferation and maintenance of natural killer (NK) and CD8 + T cells, and with great promise as an immuno-oncology therapeutic. However, IL-15 has a very short half-...
PMC12471250
core_pubmed_pmc
The VincerEmo Pilot Study: Prospective Analysis of Controlled Physical Activity in People with severe Hemophilia
The VincerEmo Pilot Study: Prospective Analysis of Controlled Physical Activity in People with severe Hemophilia Abstract Background/Objectives : The approach to physical activity in people with hemophilia (PwH) is still conditioned by many difficulties. Thus, a prospective observational pilot study has been carried ou...
PMC3418266
core_pubmed_pmc
Early Sorafenib-Induced Toxicity Is Associated with Drug Exposure and UGTIA9 Genetic Polymorphism in Patients with Solid Tumors: A Preliminary Study
Early Sorafenib-Induced Toxicity Is Associated with Drug Exposure and UGTIA9 Genetic Polymorphism in Patients with Solid Tumors: A Preliminary Study Abstract Background Identifying predictive biomarkers of drug response is of key importance to improve therapy management and drug selection in cancer therapy. To date, th...
PMC11235002
core_pubmed_pmc
First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours
First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours Abstract Objective The arginase inhibitor INCB001158 was evaluated for safety (primary endpoint) in locally advanced or metastatic solid tumours; pharmacokinetics,...
PMC4101250
core_pubmed_pmc
Phase I and pharmacokinetic study of trabectedin, a DNA minor groove binder, administered as a 24-h continuous infusion in Japanese patients with soft tissue sarcoma
Phase I and pharmacokinetic study of trabectedin, a DNA minor groove binder, administered as a 24-h continuous infusion in Japanese patients with soft tissue sarcoma Abstract Summary Background Trabectedin is a novel anticancer agent used to treat soft tissue sarcoma (STS). This phase I study of trabectedin was perform...
PMC6571994
core_pubmed_pmc
Determining the pharmacokinetics of nicotinic drugs in the endoplasmic reticulum using biosensors
Determining the pharmacokinetics of nicotinic drugs in the endoplasmic reticulum using biosensors Abstract Nicotine permeates into the endoplasmic reticulum (ER) where it begins an “inside-out” pathway that leads to addiction. Shivange et al. develop genetically encoded nicotine biosensors and show that nicotine and va...
PMC9740544
core_pubmed_pmc
Quantitative Analysis of Isoniazid and Its Four Primary Metabolites in Plasma of Tuberculosis Patients Using LC-MS/MS
Quantitative Analysis of Isoniazid and Its Four Primary Metabolites in Plasma of Tuberculosis Patients Using LC-MS/MS Abstract Isoniazid and its metabolites are potentially associated with hepatotoxicity and treatment outcomes in patients who receive antituberculosis (TB) therapy. To further understand the pharmacokine...
PMC5971337
core_pubmed_pmc
Development of an Ultra-High Performance Liquid Chromatography Method for Simultaneous Determination of Six Active Compounds in Fructus aurantii and Rat Plasma and Its Application to a Comparative Pharmacokinetic Study in Rats Administered with Different Doses
Development of an Ultra-High Performance Liquid Chromatography Method for Simultaneous Determination of Six Active Compounds in Fructus aurantii and Rat Plasma and Its Application to a Comparative Pharmacokinetic Study in Rats Administered with Different Doses Abstract Abstract A rapid, accurate, and sensitive ultra-hi...
PMC4895533
core_pubmed_pmc
Bioequivalence of Orally Administered Generic, Compounded, and Innovator‐Formulated Itraconazole in Healthy Dogs
Bioequivalence of Orally Administered Generic, Compounded, and Innovator‐Formulated Itraconazole in Healthy Dogs Abstract Background Itraconazole is commonly used to treat systemic fungal infections in dogs, but problems exist with absorption and cost. Objective To determine oral bioequivalence of generic and compounde...
PMC6771228
core_pubmed_pmc
Pharmacokinetic Aspects of Nanoparticle-in-Matrix Drug Delivery Systems for Oral/Buccal Delivery
Pharmacokinetic Aspects of Nanoparticle-in-Matrix Drug Delivery Systems for Oral/Buccal Delivery Abstract Abstract Oral route maintains its predominance among the ones used for drug delivery, especially when medicines are self-administered. If the dosage form is solid, therapy gains in dose precision and drug stability...
PMC3731825
core_pubmed_pmc
AMGET, an R-Based Postprocessing Tool for ADAPT 5
AMGET, an R-Based Postprocessing Tool for ADAPT 5 Abstract ADAPT 5 is a powerful modeling software for population pharmacokinetic and pharmacodynamic systems analysis, but provides limited built-in functionality for creating pre- and post-analysis diagnostic plots. ADAPT 5 Model Evaluation Graphical Toolkit (AMGET), an...
PMC11430436
core_pubmed_pmc
New BDNF and NT-3 Cyclic Mimetics Concur with Copper to Activate Trophic Signaling Pathways as Potential Molecular Entities to Protect Old Brains from Neurodegeneration
New BDNF and NT-3 Cyclic Mimetics Concur with Copper to Activate Trophic Signaling Pathways as Potential Molecular Entities to Protect Old Brains from Neurodegeneration Abstract Abstract A low level of Neurotrophins (NTs), their Tyrosine Kinase Receptors (Trks), Vascular Endothelial Growth Factors (VEGFs) and their rec...
PMC3985262
core_pubmed_pmc
Mathematical Modeling of the Release of Active Ingredients from a Contraceptive Patch: Ortho Evra ® as a Case Study
Mathematical Modeling of the Release of Active Ingredients from a Contraceptive Patch: Ortho Evra ® as a Case Study Abstract Abstract Contraceptive patches have become a frequently used contraceptive method. We present a mathematical model that describes the serum concentration profiles of Norelgestromin (NGMN) and Eth...
PMC10806523
core_pubmed_pmc
Therapeutic drug monitoring of mycophenolic acid and clinical outcomes of lupus nephritis: a systematic review and meta-analysis
Therapeutic drug monitoring of mycophenolic acid and clinical outcomes of lupus nephritis: a systematic review and meta-analysis Abstract Introduction Mycophenolic acid (MPA) is a primary immunosuppressive agent used in the treatment of lupus nephritis (LN). While therapeutic drug monitoring (TDM) of MPA is well establ...
PMC11831629
core_pubmed_pmc
Relationship between plasma polymyxin B concentrations and acute kidney injury in critically ill elderly patients: Findings from a prospective study
Relationship between plasma polymyxin B concentrations and acute kidney injury in critically ill elderly patients: Findings from a prospective study Abstract Abstract Objective The objective of this study was to determine the relationship between the plasma polymyxin B concentration and renal function in elderly patien...
PMC8400941
core_pubmed_pmc
Preclinical Toxicity and Safety of MM-129—First-in-Class BTK/PD-L1 Inhibitor as a Potential Candidate against Colon Cancer
Preclinical Toxicity and Safety of MM-129—First-in-Class BTK/PD-L1 Inhibitor as a Potential Candidate against Colon Cancer Abstract MM-129 is a novel inhibitor targeting BTK/PI3K/AKT/mTOR and PD-L1, as it possesses antitumor activity against colon cancer. To evaluate the safety profile of MM-129, we conducted a toxicit...
PMC11766869
core_pubmed_pmc
Exploring the Pharmacokinetics and Gut Microbiota Modulation of Hesperidin and Nobiletin from Mandarin Orange Peel in Experimental Dogs: A Pilot Study
Exploring the Pharmacokinetics and Gut Microbiota Modulation of Hesperidin and Nobiletin from Mandarin Orange Peel in Experimental Dogs: A Pilot Study Abstract Background/Objectives: Mandarin orange peel (MOP) is recognized for its traditional medicinal properties due to its high flavonoid content. This study aimed to ...
PMC5347022
core_pubmed_pmc
Mathematical Modelling to Guide Drug Development for Malaria Elimination
Mathematical Modelling to Guide Drug Development for Malaria Elimination Abstract Mathematical models of the dynamics of a drug within the host are now frequently used to guide drug development. These generally focus on assessing the efficacy and duration of response to guide patient therapy. Increasingly, antimalarial...
PMC9279759
core_pubmed_pmc
Docetaxel population pharmacokinetic modelling and simulation in Chinese cancer patients
Docetaxel population pharmacokinetic modelling and simulation in Chinese cancer patients Abstract Abstract Background Docetaxel is a widely prescribed cytotoxic chemotherapy drug for various cancers and the main dose-limiting toxicity is dose-dependent neutropenia. In China, the current dose regimen for docetaxel frequ...
PMC7004194
core_pubmed_pmc
Model‐Based Nanoengineered Pharmacokinetics of Iron‐Doped Copper Oxide for Nanomedical Applications
Model‐Based Nanoengineered Pharmacokinetics of Iron‐Doped Copper Oxide for Nanomedical Applications Abstract Abstract The progress in nanomedicine (NM) using nanoparticles (NPs) is mainly based on drug carriers for the delivery of classical chemotherapeutics. As low NM delivery rates limit therapeutic efficacy, an enti...
PMC8095338
core_pubmed_pmc
Selumetinib normalizes Ras/MAPK signaling in clinically relevant neurofibromatosis type 1 minipig tissues in vivo
Selumetinib normalizes Ras/MAPK signaling in clinically relevant neurofibromatosis type 1 minipig tissues in vivo Abstract Abstract Background The MEK1/2 inhibitor selumetinib was recently approved for neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas, but outcomes could be improved and its pharmacodyna...
PMC4931847
core_pubmed_pmc
Preclinical validation of a novel compound targeting p70S6 kinase in breast cancer
Preclinical validation of a novel compound targeting p70S6 kinase in breast cancer Abstract Abstract Breast cancer is a frequent and treatable disease. However, when recurrent, breast cancer often becomes refractory to therapy and progresses into metastatic forms that are typically incurable. Thus, understanding and ta...
PMC10066107
core_pubmed_pmc
Convolution-based approach for modeling the paliperidone extended release and Long-Acting Injectable (LAI) PK of once-, and three-monthly products administration and for optimizing the development of new LAI products
Convolution-based approach for modeling the paliperidone extended release and Long-Acting Injectable (LAI) PK of once-, and three-monthly products administration and for optimizing the development of new LAI products Abstract Abstract The aim of this paper was to develop a convolution-based modeling approach for descri...
PMC7986766
core_pubmed_pmc
Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum
Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum Abstract Abstract Novel noncombustible tobacco products offer adult smokers (ASs) alternatives to combustible cigarettes lower on the continuum of risk; however, the ab...
PMC10135783
core_pubmed_pmc
Virtual and In Vitro Screening of Natural Products Identifies Indole and Benzene Derivatives as Inhibitors of SARS-CoV-2 Main Protease (M pro )
Virtual and In Vitro Screening of Natural Products Identifies Indole and Benzene Derivatives as Inhibitors of SARS-CoV-2 Main Protease (M pro ) Abstract Abstract Simple Summary The coronavirus disease 2019 (COVID-19) pandemic caused more than 6.7 million deaths worldwide. Certain groups of individuals are still at a hi...
PMC4625861
core_pubmed_pmc
Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development
Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development Abstract Abstract This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scien...
PMC6270698
core_pubmed_pmc
Enantioselective Separation of Mirtazapine and Its Metabolites by Capillary Electrophoresis with Acetonitrile Field-Amplified Sample Stacking and Its Application
Enantioselective Separation of Mirtazapine and Its Metabolites by Capillary Electrophoresis with Acetonitrile Field-Amplified Sample Stacking and Its Application Abstract Abstract A simple, rapid and sensitive chiral capillary zone electrophoresis coupled with acetonitrile-field-amplified sample stacking method was dev...
PMC6001963
core_pubmed_pmc
Hybrid stochastic framework predicts efficacy of prophylaxis against HIV: An example with different dolutegravir prophylaxis schemes
Hybrid stochastic framework predicts efficacy of prophylaxis against HIV: An example with different dolutegravir prophylaxis schemes Abstract Abstract To achieve the 90-90-90 goals set by UNAIDS, the number of new HIV infections needs to decrease to approximately 500,000 by 2020. One of the ‘five pillars’ to achieve th...
PMC5763360
core_pubmed_pmc
Absence of Effect of Intravaginal Miconazole, Clindamycin, Nonoxynol‐9, and Tampons on the Pharmacokinetics of an Anastrozole/Levonorgestrel Intravaginal Ring
Absence of Effect of Intravaginal Miconazole, Clindamycin, Nonoxynol‐9, and Tampons on the Pharmacokinetics of an Anastrozole/Levonorgestrel Intravaginal Ring Abstract Abstract A study was performed to investigate the effect of an intravaginally administered antimycotic, an antibiotic, and a spermicide plus the co‐usag...
PMC6966669
core_pubmed_pmc
Engineering Requirements of a Herpes Simplex Virus Patient Registry: Discovery Phase of a Real-World Evidence Platform to Advance Pharmacogenomics and Personalized Medicine
Engineering Requirements of a Herpes Simplex Virus Patient Registry: Discovery Phase of a Real-World Evidence Platform to Advance Pharmacogenomics and Personalized Medicine Abstract Abstract Comprehensive pharmacogenomic understanding requires both robust genomic and demographic data. Patient registries present an oppo...
PMC6125556
core_pubmed_pmc
β-Lactam Dosage Regimens in Septic Patients with Augmented Renal Clearance
β-Lactam Dosage Regimens in Septic Patients with Augmented Renal Clearance Abstract Augmented renal clearance is commonly observed in septic patients and may result in insufficient β-lactam serum concentrations. The aims of this study were to evaluate potential correlations between drug concentrations or total body cle...
PMC4916198
core_pubmed_pmc
Combining ‘Bottom-Up’ and ‘Top-Down’ Methods to Assess Ethnic Difference in Clearance: Bitopertin as an Example
Combining ‘Bottom-Up’ and ‘Top-Down’ Methods to Assess Ethnic Difference in Clearance: Bitopertin as an Example Abstract Background and Objectives We propose a strategy for studying ethnopharmacology by conducting sequential physiologically based pharmacokinetic (PBPK) prediction (a ‘bottom-up’ approach) and population...
PMC8014833
core_pubmed_pmc
Systematic Review and Patient‐Level Meta‐Analysis of SARS‐CoV‐2 Viral Dynamics to Model Response to Antiviral Therapies
Systematic Review and Patient‐Level Meta‐Analysis of SARS‐CoV‐2 Viral Dynamics to Model Response to Antiviral Therapies Abstract Severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) viral loads change rapidly following symptom onset, so to assess antivirals it is important to understand the natural history and ...
PMC6647192
core_pubmed_pmc
Effect of ethnicity on vinorelbine pharmacokinetics: a population pharmacokinetics analysis
Effect of ethnicity on vinorelbine pharmacokinetics: a population pharmacokinetics analysis Abstract Background Pharmacokinetics of vinorelbine is mainly known from studies conducted in European patients. Interethnic differences in drug disposition may, however, induce interethnic variation in drug exposure. This paper...
PMC12737151
core_pubmed_pmc
Systematic Development and Characterization of Enzyme-Free, Borax-Crosslinked Microneedles for Glucose-Responsive Insulin Delivery and In Vivo Glycemic Mitigation
Systematic Development and Characterization of Enzyme-Free, Borax-Crosslinked Microneedles for Glucose-Responsive Insulin Delivery and In Vivo Glycemic Mitigation Abstract Abstract Background: Conventional insulin injections cannot mimic physiological pancreatic function and often lead to dangerous hypoglycemic events ...
PMC10909731
core_pubmed_pmc
A systematic review of astragaloside IV effects on animal models of diabetes mellitus and its complications
A systematic review of astragaloside IV effects on animal models of diabetes mellitus and its complications Abstract Context Diabetes mellitus (DM) is one of the fastest-growing diseases worldwide; however, its pathogenesis remains unclear. Complications seriously affect the quality of life of patients in the later sta...
PMC10629855
core_pubmed_pmc
Absorption and Bioavailability of Novel UltraShear Nanoemulsion of Cannabidiol in Rats
Absorption and Bioavailability of Novel UltraShear Nanoemulsion of Cannabidiol in Rats Abstract Abstract Introduction Cannabidiol (CBD) has several potential benefits and therapeutic uses, especially in pain, inflammation, and anxiety. CBD has high hydrophobicity and very low solubility in water. CBD has also shown exc...
PMC9923315
core_pubmed_pmc
Cardiovascular and kidney outcomes of uric acid-lowering therapy in patients with different kidney functions: study protocol for a systematic review, pairwise and network meta-analysis
Cardiovascular and kidney outcomes of uric acid-lowering therapy in patients with different kidney functions: study protocol for a systematic review, pairwise and network meta-analysis Abstract Abstract Introduction Hyperuricaemia has been implicated in the development of kidney function in populations with chronic kid...
PMC11007772
core_pubmed_pmc
Identification of Novel Quinolone and Quinazoline Alkaloids as Phosphodiesterase 10A Inhibitors for Parkinson’s Disease through a Computational Approach
Identification of Novel Quinolone and Quinazoline Alkaloids as Phosphodiesterase 10A Inhibitors for Parkinson’s Disease through a Computational Approach Abstract Abstract Phosphodiesterases (PDEs) are vital in signal transduction, specifically by hydrolyzing cAMP and cGMP. Within the PDE family, PDE10A is notable for i...
PMC12389296
core_pubmed_pmc
Sex-Specific Differences in Antidepressant and Antipsychotic Treatment Outcomes and Serum Levels in Children and Adolescents
Sex-Specific Differences in Antidepressant and Antipsychotic Treatment Outcomes and Serum Levels in Children and Adolescents Abstract Abstract Introduction: Sex-specific differences in psychopharmacological treatment have gained increasing attention in adults, with studies showing that women often have higher serum con...
PMC10820236
core_pubmed_pmc
First In Vivo Applicational Data of Foam-Based Intrathoracic Chemotherapy (FBiTC) in a Swine Model
First In Vivo Applicational Data of Foam-Based Intrathoracic Chemotherapy (FBiTC) in a Swine Model Abstract Background: For decades, both intraperitoneal and pleural chemotherapy (IPC) have been delivered as a liquid solution. Recent studies suggest that foam carriers outperform liquid carriers for locoregional chemoth...
PMC7658071
core_pubmed_pmc
Pipamperone Population Pharmacokinetics Related to Effectiveness and Side Effects in Children and Adolescents
Pipamperone Population Pharmacokinetics Related to Effectiveness and Side Effects in Children and Adolescents Abstract Background Pipamperone is a frequently prescribed antipsychotic in children and adolescents in the Netherlands, Belgium, and Germany. However, pediatric pharmacokinetics and the relationship with side ...
PMC9511805
core_pubmed_pmc
A nano-enhanced vaccine for metastatic melanoma immunotherapy
A nano-enhanced vaccine for metastatic melanoma immunotherapy Abstract Abstract Aim : Despite the huge advancements in cancer therapies and treatments over the past decade, most patients with metastasized melanoma still die from the disease. This poor prognosis largely results from resistance to conventional chemothera...
PMC9188836
core_pubmed_pmc
The Ideal Time to Administer Pre-operative Antibiotics: Current and Future Practices
The Ideal Time to Administer Pre-operative Antibiotics: Current and Future Practices Abstract Abstract Background Preoperative antibiotic prophylaxis is a method of administering antibiotics prior to surgical procedures to decrease surgical site infections. The Center for Disease Control and Prevention (CDC) guidelines...
PMC8597757
core_pubmed_pmc
Pharmacokinetic and Safety Profile of the Novel HIV Nonnucleoside Reverse Transcriptase Inhibitor MK-8507 in Adults without HIV
Pharmacokinetic and Safety Profile of the Novel HIV Nonnucleoside Reverse Transcriptase Inhibitor MK-8507 in Adults without HIV Abstract ABSTRACT MK-8507 is a novel HIV-1 nonnucleoside reverse transcriptase inhibitor in clinical development with potential for once-weekly oral administration for the treatment of HIV-1 i...
PMC12893244
core_pubmed_pmc
Pharmacokinetics and tolerability of single‐dose Staccato® alprazolam in adolescents with epilepsy, and population pharmacokinetic analysis to support dose selection in adolescents
Pharmacokinetics and tolerability of single‐dose Staccato® alprazolam in adolescents with epilepsy, and population pharmacokinetic analysis to support dose selection in adolescents Abstract Abstract Objective Staccato® alprazolam is a hand‐held inhalation device that provides rapid systemic delivery of alprazolam throu...
PMC9994845
core_pubmed_pmc
Broadly neutralizing antibody-mediated protection against simian-HIV infection among macaques with vaginal sexually transmitted infections
Broadly neutralizing antibody-mediated protection against simian-HIV infection among macaques with vaginal sexually transmitted infections Abstract Objective: Sexually transmitted infections (STIs) increase mucosal HIV infection risk and have the potential to reduce preexposure prophylaxis efficacy. Clinical trials of ...
PMC9813109
core_pubmed_pmc
Phase I dose-escalation study of milademetan in patients with relapsed or refractory acute myeloid leukemia
Phase I dose-escalation study of milademetan in patients with relapsed or refractory acute myeloid leukemia Abstract Abstract Long-term survival in patients with acute myeloid leukemia (AML) remains low, and current treatment modalities are inadequate. Milademetan (DS-3032, RAIN-32), a small-molecule specific murine do...
PMC12299926
core_pubmed_pmc
Food–Drug Interactions: Effect of Propolis on the Pharmacokinetics of Enrofloxacin and Its Active Metabolite Ciprofloxacin in Rabbits
Food–Drug Interactions: Effect of Propolis on the Pharmacokinetics of Enrofloxacin and Its Active Metabolite Ciprofloxacin in Rabbits Abstract Propolis is a natural resinous substance produced by honeybees that has many biological activities. For thousands of years, it has been widely used as a dietary supplement and t...
PMC4971498
core_pubmed_pmc
Pre-Clinical Study of a Novel Recombinant Botulinum Neurotoxin Derivative Engineered for Improved Safety
Pre-Clinical Study of a Novel Recombinant Botulinum Neurotoxin Derivative Engineered for Improved Safety Abstract Cyto-012 is a recombinant derivative of Botulinum neurotoxin Type A (BoNT/A). It primarily differs from wild type ( wt ) BoNT/A1 in that it incorporates two amino acid substitutions in the catalytic domain ...
PMC12659765
core_pubmed_pmc
A Phase 1 Trial of Fimepinostat in Children and Adolescents With Relapsed and Refractory Solid and CNS Tumors
A Phase 1 Trial of Fimepinostat in Children and Adolescents With Relapsed and Refractory Solid and CNS Tumors Abstract ABSTRACT Background Fimepinostat, an oral dual inhibitor of histone deacetylase (HDAC) and phosphatidylinositol‐4,5‐bisphosphate 3‐kinase (PI3K), has shown activity in preclinical models of Myc‐driven ...
PMC7387953
core_pubmed_pmc
Simultaneous Determination of Multiple Active Components from Bushen Pills and Application in a Pharmacokinetic Study in Rats
Simultaneous Determination of Multiple Active Components from Bushen Pills and Application in a Pharmacokinetic Study in Rats Abstract Bushen Pills (BSPs), as a traditional Chinese medicine (TCM), is widely used in clinic to enrich Yang, nourish Yin, stem essence, and strengthen kidneys. Two chromatographic methods, li...
PMC6048868
core_pubmed_pmc
A Mobile Infliximab Dosing Calculator for Therapy Optimization in Inflammatory Bowel Disease
A Mobile Infliximab Dosing Calculator for Therapy Optimization in Inflammatory Bowel Disease Abstract Abstract Background Inadequate infliximab (IFX) drug exposure remains a clinical challenge and leads to high loss of response rates and therapy failure in inflammatory bowel disease (IBD). We aimed to determine the fea...
PMC5626502
core_pubmed_pmc
Evaluation of the pharmacokinetic-pharmacodynamic relationship of praziquantel in the Schistosoma mansoni mouse model
Evaluation of the pharmacokinetic-pharmacodynamic relationship of praziquantel in the Schistosoma mansoni mouse model Abstract After more than 40 years of use, Praziquantel (PZQ) still remains the drug of choice for the treatment of intestinal and urogenital schistosomiasis. Its anti-parasitic activity resides primaril...
PMC3746734
core_pubmed_pmc
Process optimization and evaluation of novel baicalin solid nanocrystals
Process optimization and evaluation of novel baicalin solid nanocrystals Abstract Abstract The objective of this study was to prepare baicalin solid nanocrystals (BCN-SNS) to enhance oral bioavailability of baicalin. A Box–Behnken design approach was used for process optimization. The physicochemical properties and pha...
PMC9017425
core_pubmed_pmc
Integrative Analysis of Pharmacokinetic and Metabolomic Profiles for Predicting Metabolic Phenotype and Drug Exposure Caused by Sotorasib in Rats
Integrative Analysis of Pharmacokinetic and Metabolomic Profiles for Predicting Metabolic Phenotype and Drug Exposure Caused by Sotorasib in Rats Abstract Abstract Sotorasib is a novel targeted inhibitor of Kirsten rat sarcoma (KRAS) (G12C) that has shown exciting tumor-suppressing effects not only for single targeted ...
PMC8899564
core_pubmed_pmc
Self-assembly of nanomicelles with rationally designed multifunctional building blocks for synergistic chemo-photodynamic therapy
Self-assembly of nanomicelles with rationally designed multifunctional building blocks for synergistic chemo-photodynamic therapy Abstract Abstract Rationale : The combination of photosensitizers, oxygen supply agents, and adjuvant therapy drugs in a single nano-drug delivery system for photodynamic therapy (PDT) has b...
PMC5471993
core_pubmed_pmc
Integrated pharmacokinetic–Pharmacodynamic (PK/PD) model to evaluate the in vivo antimicrobial activity of Marbofloxacin against Pasteurella multocida in piglets
Integrated pharmacokinetic–Pharmacodynamic (PK/PD) model to evaluate the in vivo antimicrobial activity of Marbofloxacin against Pasteurella multocida in piglets Abstract Abstract Background Marbofloxacin is a veterinary fluoroquinolone with high activity against Pasteurella multocida. We evaluated it’s in vivo activit...
PMC4824384
core_pubmed_pmc
Safety, Tolerability, and Pharmacokinetics of SMT C1100, a 2-Arylbenzoxazole Utrophin Modulator, following Single- and Multiple-Dose Administration to Pediatric Patients with Duchenne Muscular Dystrophy
Safety, Tolerability, and Pharmacokinetics of SMT C1100, a 2-Arylbenzoxazole Utrophin Modulator, following Single- and Multiple-Dose Administration to Pediatric Patients with Duchenne Muscular Dystrophy Abstract Abstract Purpose SMT C1100 is a utrophin modulator being evaluated as a treatment for Duchenne muscular dyst...
PMC12466039
core_pubmed_pmc
PKSmart: an open-source computational model to predict intravenous pharmacokinetics of small molecules
PKSmart: an open-source computational model to predict intravenous pharmacokinetics of small molecules Abstract Abstract Drug exposure, a key determinant of drug safety and efficacy, is governed by pharmacokinetic (PK) parameters such as volume of distribution (VDss), clearance (CL), half-life (t½), fraction unbound in...
PMC4039392
core_pubmed_pmc
Population Pharmacokinetics of Azithromycin in Whole Blood, Peripheral Blood Mononuclear Cells, and Polymorphonuclear Cells in Healthy Adults
Population Pharmacokinetics of Azithromycin in Whole Blood, Peripheral Blood Mononuclear Cells, and Polymorphonuclear Cells in Healthy Adults Abstract Azithromycin's extensive distribution to proinflammatory cells, including peripheral blood mononuclear cells (PBMCs) and polymorphonuclear cells (PMNs), may be important...
PMC6626766
core_pubmed_pmc
Current trends and challenges in cancer management and therapy using designer nanomaterials
Current trends and challenges in cancer management and therapy using designer nanomaterials Abstract Nanotechnology has the potential to circumvent several drawbacks of conventional therapeutic formulations. In fact, significant strides have been made towards the application of engineered nanomaterials for the treatmen...
PMC12609813
core_pubmed_pmc
Pharmacokinetics and Pharmacodynamics of Perfluorooctane Sulfonate (PFOS) and Its Role in the Development and Progression of Prostate, Ovarian and Breast Cancers
Pharmacokinetics and Pharmacodynamics of Perfluorooctane Sulfonate (PFOS) and Its Role in the Development and Progression of Prostate, Ovarian and Breast Cancers Abstract Simple Summary Perfluorooctane sulfonate (PFOS) is a synthetic chemical found in products like firefighting foams, stain-resistant fabrics, and food ...
PMC4209236
core_pubmed_pmc
A phase I dose-escalation study of MEDI-575, a PDGFRα monoclonal antibody, in adults with advanced solid tumors
A phase I dose-escalation study of MEDI-575, a PDGFRα monoclonal antibody, in adults with advanced solid tumors Abstract Purpose The purpose of the study was to evaluate safety and determine the maximum tolerated dose (MTD) of MEDI-575, a fully human monoclonal antibody that selectively binds to platelet-derived growth...
PMC6397141
core_pubmed_pmc
Clinical Pharmacology of Ixazomib: The First Oral Proteasome Inhibitor
Clinical Pharmacology of Ixazomib: The First Oral Proteasome Inhibitor Abstract Ixazomib, the first oral proteasome inhibitor, is approved in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. Ixazomib is a selective, po...
PMC11358263
core_pubmed_pmc
Machine-learning model to predict the tacrolimus concentration and suggest optimal dose in liver transplantation recipients: a multicenter retrospective cohort study
Machine-learning model to predict the tacrolimus concentration and suggest optimal dose in liver transplantation recipients: a multicenter retrospective cohort study Abstract Abstract Titrating tacrolimus concentration in liver transplantation recipients remains a challenge in the early post-transplant period. This mul...
PMC11647204
core_pubmed_pmc
Phase Ib Study of the Immunocytokine Simlukafusp Alfa (FAP-IL2v) in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma
Phase Ib Study of the Immunocytokine Simlukafusp Alfa (FAP-IL2v) in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma Abstract Abstract Purpose: This phase Ib trial evaluated fibroblast activation protein-α–targeted IL2 variant (FAP-IL2v), a novel immunocytokine engineered to minimize CD...
PMC6268819
core_pubmed_pmc
Modeling Chemical Interaction Profiles: II. Molecular Docking, Spectral Data-Activity Relationship, and Structure-Activity Relationship Models for Potent and Weak Inhibitors of Cytochrome P450 CYP3A4 Isozyme
Modeling Chemical Interaction Profiles: II. Molecular Docking, Spectral Data-Activity Relationship, and Structure-Activity Relationship Models for Potent and Weak Inhibitors of Cytochrome P450 CYP3A4 Isozyme Abstract Abstract Polypharmacy increasingly has become a topic of public health concern, particularly as the U.S...
PMC12540372
core_pubmed_pmc
A digital twin of glimepiride for personalized and stratified diabetes treatment
A digital twin of glimepiride for personalized and stratified diabetes treatment Abstract Introduction Optimizing glimepiride therapy for type 2 diabetes (T2DM) is challenged by pronounced inter-individual variability in pharmacokinetics. Methods We developed a whole-body physiologically based pharmacokinetic (PBPK) mo...
PMC11365676
core_pubmed_pmc
Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study Abstract Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease that a...
PMC5744176
core_pubmed_pmc
Dose Selection Based on Modeling and Simulation for Rivipansel in Pediatric Patients Aged 6 to 11 Years With Sickle Cell Disease
Dose Selection Based on Modeling and Simulation for Rivipansel in Pediatric Patients Aged 6 to 11 Years With Sickle Cell Disease Abstract This modeling and simulation exercise aimed to provide dosing recommendations for rivipansel phase III studies in children aged 6–11 years with sickle cell disease (SCD). Pharmacokin...
PMC4588449
core_pubmed_pmc
A phase 1 study of a heterologous prime-boost vaccination involving a truncated HER2 sequence in patients with HER2-expressing breast cancer
A phase 1 study of a heterologous prime-boost vaccination involving a truncated HER2 sequence in patients with HER2-expressing breast cancer Abstract A phase 1 clinical trial was conducted to assess the safety, tolerability, and preliminary efficacy of a heterologous prime-boost strategy involving plasmid DNA (pHM-GM-C...
PMC9382074
core_pubmed_pmc
Quantification of pharmacokinetic profiles of a recombinant canine PD-1 fusion protein by validated sandwich ELISA method
Quantification of pharmacokinetic profiles of a recombinant canine PD-1 fusion protein by validated sandwich ELISA method Abstract Tumors are becoming a serious threat to the quality of life of human and dogs. Studies have shown that tumors have caused more than half of the deaths in older dogs. Similar to human, dogs ...
PMC6171568
core_pubmed_pmc
Real-World Experience With Higher-Than-Recommended Doses of Lamivudine in Patients With Varying Degrees of Renal Impairment
Real-World Experience With Higher-Than-Recommended Doses of Lamivudine in Patients With Varying Degrees of Renal Impairment Abstract Abstract Background Although nucleoside reverse transcriptase inhibitors have been associated with lactic acidosis, lamivudine (3TC) has not been reported to have an increased risk with e...
PMC7520420
core_pubmed_pmc
Use of translational modeling and simulation for quantitative comparison of PF-06804103, a new generation HER2 ADC, with Trastuzumab-DM1
Use of translational modeling and simulation for quantitative comparison of PF-06804103, a new generation HER2 ADC, with Trastuzumab-DM1 Abstract A modeling and simulation approach was used for quantitative comparison of a new generation HER2 antibody drug conjugate (ADC, PF-06804103) with trastuzumab-DM1 (T-DM1). To c...
PMC8541959
core_pubmed_pmc
Phase 1 dose escalation study of seribantumab (MM-121), an anti-HER3 monoclonal antibody, in patients with advanced solid tumors
Phase 1 dose escalation study of seribantumab (MM-121), an anti-HER3 monoclonal antibody, in patients with advanced solid tumors Abstract Background Overactivation of human epidermal growth factor receptor 3 (HER3) triggers multiple intracellular pathways resulting in tumor cell survival. This Phase 1 study assessed th...
PMC11783357
core_pubmed_pmc
Enhanced Oral Bioavailability and Biodistribution of Voriconazole through Zein-Pectin-Hyaluronic Acid Nanoparticles
Enhanced Oral Bioavailability and Biodistribution of Voriconazole through Zein-Pectin-Hyaluronic Acid Nanoparticles Abstract Abstract Nanotechnology-based drug delivery systems offer a solution to the pharmacokinetic limitations of voriconazole (VRC), including saturable metabolism and low oral bioavailability. This st...
PMC8350115
core_pubmed_pmc
Caffeine for the Pharmacological Treatment of Apnea of Prematurity in the NICU: Dose Selection Conundrum, Therapeutic Drug Monitoring and Genetic Factors
Caffeine for the Pharmacological Treatment of Apnea of Prematurity in the NICU: Dose Selection Conundrum, Therapeutic Drug Monitoring and Genetic Factors Abstract Caffeine citrate is the drug of choice for the pharmacological treatment of apnea of prematurity. Factors such as maturity and genetic variation contribute t...
PMC9881081
core_pubmed_pmc
Transient Opening of the Blood-Brain Barrier by Vasoactive Peptides to Increase CNS Drug Delivery: Reality Versus Wishful Thinking?
Transient Opening of the Blood-Brain Barrier by Vasoactive Peptides to Increase CNS Drug Delivery: Reality Versus Wishful Thinking? Abstract Abstract Background : The blood-brain barrier inhibits the central nervous system penetration of 98% of small molecule drugs and virtually all biologic agents, which has limited p...
PMC9298019
core_pubmed_pmc
Exposure–response analysis of acalabrutinib and its active metabolite, ACP‐5862, in patients with B‐cell malignancies
Exposure–response analysis of acalabrutinib and its active metabolite, ACP‐5862, in patients with B‐cell malignancies Abstract Aims Examine relationships between the systemic exposure of acalabrutinib, a highly selective, next‐generation Bruton tyrosine kinase inhibitor, and its active metabolite (ACP‐5862) vs . effica...
PMC12707663
core_pubmed_pmc
Diagnostic performance of four AI tools in pharmacology MCQs: Accuracy, sensitivity, and specificity
Diagnostic performance of four AI tools in pharmacology MCQs: Accuracy, sensitivity, and specificity Abstract Abstract Background The rapid rise of AI in medical and pharmaceutical education has engendered much interest; however, a knowledge gap still exists in the evaluation of performances of these tools in critical ...
PMC3632974
core_pubmed_pmc
Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study
Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study Abstract Abstract Objectives The primary objective of this analysis was to characterise the steady-state pharmacokinetics (PK) of ethinylestradi...
PMC6389350
core_pubmed_pmc
Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives
Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives Abstract Abstract Good practices around model‐informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within dru...
PMC9960255
core_pubmed_pmc
An Insight into Wheat Germ Oil Nutrition, Identification of Its Bioactive Constituents and Computer-Aided Multidimensional Data Analysis of Its Potential Anti-Inflammatory Effect via Molecular Connections
An Insight into Wheat Germ Oil Nutrition, Identification of Its Bioactive Constituents and Computer-Aided Multidimensional Data Analysis of Its Potential Anti-Inflammatory Effect via Molecular Connections Abstract Wheat germ oil (WGO) is the richest source of unexplored antioxidants and anti-inflammatory compounds. In ...
PMC12901331
core_pubmed_pmc
Case Report: Severe SIADH and QTc prolongation induced by escitalopram-quetiapine interaction in a CYP2C19 intermediate metabolizer at therapeutic doses
Case Report: Severe SIADH and QTc prolongation induced by escitalopram-quetiapine interaction in a CYP2C19 intermediate metabolizer at therapeutic doses Abstract Abstract Escitalopram is widely regarded as a well-tolerated selective serotonin reuptake inhibitor (SSRI) with a favorable safety profile. However, severe ad...