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PMC11913096
core_pubmed_pmc
MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial
MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial Abstract Abstract Context Hypoparathyroidism denotes parathyroid hormone (PTH) deficiency and impaired mineral metabolism. MBX 2109, a novel prodrug yielding a biologically active PTH peptide agonist (PTH,...
PMC7520416
core_pubmed_pmc
Prior information for population pharmacokinetic and pharmacokinetic/pharmacodynamic analysis: overview and guidance with a focus on the NONMEM PRIOR subroutine
Prior information for population pharmacokinetic and pharmacokinetic/pharmacodynamic analysis: overview and guidance with a focus on the NONMEM PRIOR subroutine Abstract Abstract Abstract Population pharmacokinetic analysis is used to estimate pharmacokinetic parameters and their variability from concentration data. Du...
PMC8188465
core_pubmed_pmc
PBPK model reporting template for chemical risk assessment applications
PBPK model reporting template for chemical risk assessment applications Abstract Abstract Physiologically-based pharmacokinetic (PBPK) modeling analysis does not stand on its own for regulatory purposes but is a robust tool to support drug/chemical safety assessment. While the development of PBPK models have grown stea...
PMC4171013
core_pubmed_pmc
Characterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum
Characterization of a quantitative method to measure free proprotein convertase subtilisin/kexin type 9 in human serum Abstract Abstract Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a serine protease that plays an important role in the regulation of serum low-density lipoprotein (LDL) cholesterol by downreg...
PMC4376748
core_pubmed_pmc
Pharmacokinetics and Tolerability of Inhaled Umeclidinium and Vilanterol Alone and in Combination in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Trial
Pharmacokinetics and Tolerability of Inhaled Umeclidinium and Vilanterol Alone and in Combination in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Trial Abstract Inhaled umeclidinium (UMEC) and the combination of inhaled UMEC with vilanterol (UMEC/VI) are approved maintenance treatments for chronic obst...
PMC8067465
core_pubmed_pmc
Developing pH-Modulated Spray Dried Amorphous Solid Dispersion of Candesartan Cilexetil with Enhanced In Vitro and In Vivo Performance
Developing pH-Modulated Spray Dried Amorphous Solid Dispersion of Candesartan Cilexetil with Enhanced In Vitro and In Vivo Performance Abstract Abstract Candesartan cilexetil (CC), a prodrug and highly effective antihypertensive agent, is a poorly soluble (BCS Class II) drug with limited bioavailability. Here, we attem...
PMC12653362
core_pubmed_pmc
Digital Twins in Pediatric Infectious Diseases: Virtual Models for Personalized Management
Digital Twins in Pediatric Infectious Diseases: Virtual Models for Personalized Management Abstract Digital twins (DTs), virtual replicas that integrate mechanistic modeling with real-time clinical data, are emerging as powerful tools in healthcare with particular promise in pediatrics, where age-dependent physiology a...
PMC11150559
core_pubmed_pmc
Immunomodulation profile of the biosimilar trastuzumab MYL-1401O in a bioequivalence phase I study
Immunomodulation profile of the biosimilar trastuzumab MYL-1401O in a bioequivalence phase I study Abstract Abstract The initial Phase-I single centre, single dose, randomized, double-blind, cross-over study was planned to assess the pharmacokinetic and pharmacodynamic bioequivalence of the trastuzumab biosimilar (MYL-...
PMC6590134
core_pubmed_pmc
Population Pharmacokinetic Modeling of Acetaminophen and Metabolites in Children After Cardiac Surgery With Cardiopulmonary Bypass
Population Pharmacokinetic Modeling of Acetaminophen and Metabolites in Children After Cardiac Surgery With Cardiopulmonary Bypass Abstract Abstract Children undergoing cardiac surgery often receive acetaminophen (paracetamol) as part of their postoperative pain treatment. To date, there is no information on the pharma...
PMC8604822
core_pubmed_pmc
Linking categorical models for prediction of pleasantness score using individual predictions of sweetness and creaminess: An advancement of categorical modeling
Linking categorical models for prediction of pleasantness score using individual predictions of sweetness and creaminess: An advancement of categorical modeling Abstract Abstract The aim of this work was to develop and evaluate approaches of linked categorical models using individual predictions of probability. A model...
PMC11313909
core_pubmed_pmc
Exploring the Potential of Oleanolic Acid Dimers–Cytostatic and Antioxidant Activities, Molecular Docking, and ADMETox Profile
Exploring the Potential of Oleanolic Acid Dimers–Cytostatic and Antioxidant Activities, Molecular Docking, and ADMETox Profile Abstract The presented work aimed to explore the potential of oleanolic acid dimers (OADs): their cytostatic and antioxidant activities, molecular docking, pharmacokinetics, and ADMETox profile...
PMC9576439
core_pubmed_pmc
In Silico Identification of New Anti-SARS-CoV-2 Main Protease (M pro ) Molecules with Pharmacokinetic Properties from Natural Sources Using Molecular Dynamics (MD) Simulations and Hierarchical Virtual Screening
In Silico Identification of New Anti-SARS-CoV-2 Main Protease (M pro ) Molecules with Pharmacokinetic Properties from Natural Sources Using Molecular Dynamics (MD) Simulations and Hierarchical Virtual Screening Abstract Infectious agents such as SARS-CoV, MERS-CoV, and SARS-CoV-2 have emerged in recent years causing ep...
PMC11919258
core_pubmed_pmc
Analysis of C4 Concentrations to Predict Impact of Patient‐Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat
Analysis of C4 Concentrations to Predict Impact of Patient‐Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat Abstract ABSTRACT Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, is being evaluated for the treatment of pruritus in primary biliary cholangitis (PBC). Diarrh...
PMC4895289
core_pubmed_pmc
Reviewing 15 years of experience with sirolimus
Reviewing 15 years of experience with sirolimus Abstract Abstract Here, we review 15 years of clinical use of sirolimus in our transplant center, in context with the developing immunosuppressive strategies use worldwide. The majority of studies were conducted in de novo kidney transplant recipients, using sirolimus (SR...
PMC8868220
core_pubmed_pmc
Curcumin: Biological Activities and Modern Pharmaceutical Forms
Curcumin: Biological Activities and Modern Pharmaceutical Forms Abstract Curcumin (1,7-bis-(4-hydroxy-3-methoxyphenyl)-hepta-1,6-diene-3,5-dione) is a natural lipophilic polyphenol that exhibits significant pharmacological effects in vitro and in vivo through various mechanisms of action. Numerous studies have identifi...
PMC10740541
core_pubmed_pmc
Comparative Meropenem Pharmacodynamics and Emergence of Resistance against Carbapenem-Susceptible Non-Carbapenemase-Producing and Carbapenemase-Producing Enterobacterales: A Pharmacodynamic Study in a Hollow-Fiber Infection Model
Comparative Meropenem Pharmacodynamics and Emergence of Resistance against Carbapenem-Susceptible Non-Carbapenemase-Producing and Carbapenemase-Producing Enterobacterales: A Pharmacodynamic Study in a Hollow-Fiber Infection Model Abstract Resistance to carbapenems has become a problem due to Klebsiella pneumoniae ( K. ...
PMC5951219
core_pubmed_pmc
Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of fimasartan, amlodipine, and rosuvastatin using partial replicated design in healthy adult subjects
Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of fimasartan, amlodipine, and rosuvastatin using partial replicated design in healthy adult subjects Abstract Objective The aim of this study was to compare the pharmacokinetics (PK) and safety profiles of a fixed-dose combination...
PMC11054815
core_pubmed_pmc
Cryo-Milled β-Glucan Nanoparticles for Oral Drug Delivery
Cryo-Milled β-Glucan Nanoparticles for Oral Drug Delivery Abstract Gemcitabine is a nucleoside analog effective against a number of cancers. However, it has an oral bioavailability of less than 10%, due to its high hydrophilicity and low permeability through the intestinal epithelium. Therefore, the aim of this project...
PMC12782866
core_pubmed_pmc
Preclinical Pharmacological and Toxicological Evaluation of SB5794, a Novel Aryl Hydrocarbon Receptor Modulator on the Kynurenine–AhR Axis
Preclinical Pharmacological and Toxicological Evaluation of SB5794, a Novel Aryl Hydrocarbon Receptor Modulator on the Kynurenine–AhR Axis Abstract Abstract Conventional aryl hydrocarbon receptor (AhR) antagonists, which play a critical role in modulating tumor immune evasion, have shown limited clinical translation du...
PMC6201861
core_pubmed_pmc
Generation and characterization of novel recombinant anti-hERG1 scFv antibodies for cancer molecular imaging
Generation and characterization of novel recombinant anti-hERG1 scFv antibodies for cancer molecular imaging Abstract Abstract Modern molecular imaging techniques have greatly improved tumor detection and post-treatment follow-up of cancer patients. In this context, antibody-based imaging is rapidly becoming the gold s...
PMC10963774
core_pubmed_pmc
Pharmacokinetic and pharmacodynamic evaluation study of etomidate: a randomized, open-label, 2-period crossover study in healthy Chinese subjects
Pharmacokinetic and pharmacodynamic evaluation study of etomidate: a randomized, open-label, 2-period crossover study in healthy Chinese subjects Abstract Etomidate is a sedative and hypnotic drug through intravenous administration that act on the central nervous system through GABA (Gamma-Amino Butyric Acid) receptors...
PMC12144343
core_pubmed_pmc
Predicting drug–drug interactions and optimal dosing of betrixaban with physiologically based pharmacokinetic modeling in patients with renal impairment who were coadministered with P-glycoprotein inhibitors
Predicting drug–drug interactions and optimal dosing of betrixaban with physiologically based pharmacokinetic modeling in patients with renal impairment who were coadministered with P-glycoprotein inhibitors Abstract Objective To optimize dosing adjustments in patients with renal impairment who were coadministered with...
PMC7757978
core_pubmed_pmc
A Randomized, Open, Single-Centre, Crossed Study of the Effect of Food on the Pharmacokinetics of One Oral Dose of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Subjects
A Randomized, Open, Single-Centre, Crossed Study of the Effect of Food on the Pharmacokinetics of One Oral Dose of Alflutinib Mesylate Tablets (AST2818) in Healthy Male Subjects Abstract Abstract The aim of the study was to study the PK of AST2818 tablets after one oral dose in healthy male subjects on an empty stomach...
PMC5404562
core_pubmed_pmc
Prediction of Improved Antimalarial Chemoprevention with Weekly Dosing of Dihydroartemisinin-Piperaquine
Prediction of Improved Antimalarial Chemoprevention with Weekly Dosing of Dihydroartemisinin-Piperaquine Abstract ABSTRACT Intermittent preventive treatment (IPT) is used to reduce malaria morbidity and mortality, especially in vulnerable groups such as children and pregnant women. IPT with the fixed dose combination o...
PMC7064600
core_pubmed_pmc
Ensemble modeling highlights importance of understanding parasite-host behavior in preclinical antimalarial drug development
Ensemble modeling highlights importance of understanding parasite-host behavior in preclinical antimalarial drug development Abstract Abstract Emerging drug resistance and high-attrition rates in early and late stage drug development necessitate accelerated development of antimalarial compounds. However, systematic and...
PMC12899163
core_pubmed_pmc
Combined Nanoparticle-Based Delivery of Estrogens and Raloxifen in Postmenopausal Osteoporosis
Combined Nanoparticle-Based Delivery of Estrogens and Raloxifen in Postmenopausal Osteoporosis Abstract Osteoporosis (OP) is a common chronic disease that significantly increases the risk of bone fractures. Pharmacotherapy uses, among others, 17beta-estradiol (E2), which has been replaced in recent years by raloxifene ...
PMC12706401
core_pubmed_pmc
Comparative Analysis of Isavuconazole DDIs With Other Azole Antifungal Drugs and PBPK Model‐Informed Dosing Recommendations for Anticancer Drugs
Comparative Analysis of Isavuconazole DDIs With Other Azole Antifungal Drugs and PBPK Model‐Informed Dosing Recommendations for Anticancer Drugs Abstract ABSTRACT Isavuconazole is a broad‐spectrum triazole approved for the treatment of invasive aspergillosis or mucormycosis in adults and children aged ≥ 1 year. Current...
PMC6151385
core_pubmed_pmc
Simultaneous Determination of Seven Phenolic Acids in Rat Plasma Using UHPLC-ESI-MS/MS after Oral Administration of Echinacea purpurea Extract
Simultaneous Determination of Seven Phenolic Acids in Rat Plasma Using UHPLC-ESI-MS/MS after Oral Administration of Echinacea purpurea Extract Abstract Abstract A rapid and sensitive Ultra High Performance Liquid Chromatography Electrospray Ionization Tandem Mass Spectrometry (UHPLC-ESI-MS/MS) method was developed and ...
PMC6058601
core_pubmed_pmc
Improved lymphatic targeting: effect and mechanism of synthetic borneol on lymph node uptake of 7-ethyl-10-hydroxycamptothecin nanoliposomes following subcutaneous administration
Improved lymphatic targeting: effect and mechanism of synthetic borneol on lymph node uptake of 7-ethyl-10-hydroxycamptothecin nanoliposomes following subcutaneous administration Abstract Abstract Borneol as a penetration enhancer is widely used in guiding other components through the biological barrier into the target...
PMC6201082
core_pubmed_pmc
Population Pharmacokinetics of Tafenoquine, a Novel Antimalarial
Population Pharmacokinetics of Tafenoquine, a Novel Antimalarial Abstract Tafenoquine is a novel 8-aminoquinoline antimalarial drug recently approved by the U.S. Food and Drug Administration (FDA) for the radical cure of acute Plasmodium vivax malaria, which is the first new treatment in almost 60 years. KEYWORDS: tafe...
PMC12722991
core_pubmed_pmc
A phase Ib/II study of modakafusp alfa alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors
A phase Ib/II study of modakafusp alfa alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors Abstract Background Modakafusp alfa is a novel immunocytokine comprising two attenuated interferon-α2b molecules fused to an anti-CD38 IgG4 monoclonal antibody. Modakafusp alfa has sho...
PMC7559546
core_pubmed_pmc
Pharmacokinetic Comparison of Three Different Administration Routes for Topotecan Hydrochloride in Rats
Pharmacokinetic Comparison of Three Different Administration Routes for Topotecan Hydrochloride in Rats Abstract Abstract Topotecan is actively used in clinic, with its primary use being in treatment of various types of cancer. The approved administration routes are oral and intravenous. The purpose of this study was t...
PMC11677465
core_pubmed_pmc
Development of a PET Probe Targeting Bromodomain and Extra-Terminal Proteins for In Vitro and In Vivo Visualization
Development of a PET Probe Targeting Bromodomain and Extra-Terminal Proteins for In Vitro and In Vivo Visualization Abstract Abstract Background: Bromodomain and extra-terminal (BET) proteins are critical regulators of gene transcription, as they recognize acetylated lysine residues. The BD1 bromodomain of BRD4, a memb...
PMC12323519
core_pubmed_pmc
Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial
Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial Abstract Abstract Background Despite improved outcomes with immune checkpoint inhibitors (ICIs) and their combinations in advanced solid tumors, a subset of patients remai...
PMC3415771
core_pubmed_pmc
Monitoring imatinib plasma concentrations in chronic myeloid leukemia
Monitoring imatinib plasma concentrations in chronic myeloid leukemia Abstract Abstract Imatinib has proved to be effective in the treatment of chronic myeloid leukemia, but plasma levels above 1,000 ng/mL must be achieved to optimize activity. Therapeutic drug monitoring of imatinib is useful for patients that do not ...
PMC10023024
core_pubmed_pmc
Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects
Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects Abstract Background Prescribing information instructs taking oral semaglutide (a glucagon-like peptide-1 analogue) in the fasting state, followed by a post-dose fasting period of ≥ 30 min. This trial c...
PMC8596765
core_pubmed_pmc
Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects
Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects Abstract Abstract This phase 1, 2‐part, 2‐period, open‐label, drug‐drug interaction study evaluated the potential for pharmacokinetic interactions between upadacitinib and rosuvastatin, an organic anion transporting polyp...
PMC6709420
core_pubmed_pmc
A Minimal Physiologically‐Based Pharmacokinetic Model for Tacrolimus in Living‐Donor Liver Transplantation: Perspectives Related to Liver Regeneration and the cytochrome P450 3A5 (CYP3A5) Genotype
A Minimal Physiologically‐Based Pharmacokinetic Model for Tacrolimus in Living‐Donor Liver Transplantation: Perspectives Related to Liver Regeneration and the cytochrome P450 3A5 (CYP3A5) Genotype Abstract Abstract In adult patients after living‐donor liver transplantation, postoperative days and the cytochrome P450 3A...
PMC7172977
core_pubmed_pmc
Stem cell-based Lung-on-Chips: The best of both worlds? ☆
Stem cell-based Lung-on-Chips: The best of both worlds? ☆ Abstract Pathologies of the respiratory system such as lung infections, chronic inflammatory lung diseases, and lung cancer are among the leading causes of morbidity and mortality, killing one in six people worldwide. Development of more effective treatments is ...
PMC11958634
core_pubmed_pmc
Computational discovery of natural inhibitors targeting enterovirus D68 3C protease using molecular docking pharmacokinetics and dynamics simulations
Computational discovery of natural inhibitors targeting enterovirus D68 3C protease using molecular docking pharmacokinetics and dynamics simulations Abstract Enterovirus D68 (EV-D68) is a significant global health threat, responsible for severe respiratory and neurological complications, with no FDA-approved antiviral...
PMC12487479
core_pubmed_pmc
Safety, pharmacokinetics, and pharmacodynamics of Dexmedetomidine two-phase flow atomization in healthy subjects: a randomized, parallel study
Safety, pharmacokinetics, and pharmacodynamics of Dexmedetomidine two-phase flow atomization in healthy subjects: a randomized, parallel study Abstract Abstract Background In this study, we aimed to compare the sedative effects, pharmacokinetics (PKs), and safety of dexmedetomidine (DEX) administered using a two-phase ...
PMC12286339
core_pubmed_pmc
TunR2, a novel mode-of-action tunicamycin-type antibiotic: Pharmacokinetics in C57BL/6 mouse and Holstein cattle
TunR2, a novel mode-of-action tunicamycin-type antibiotic: Pharmacokinetics in C57BL/6 mouse and Holstein cattle Abstract We have investigated the pharmacokinetics of TunR2, a modified tunicamycin-type antibiotic, in mice and cattle. TunR2 has previously been shown to be effective in a mycobacterial disease model using...
PMC7917791
core_pubmed_pmc
Circulation of Fluorescently Labelled Phage in a Murine Model
Circulation of Fluorescently Labelled Phage in a Murine Model Abstract Abstract Interactions between bacteriophages and mammals strongly affect possible applications of bacteriophages. This has created a need for tools that facilitate studies of phage circulation and deposition in tissues. Here, we propose red fluoresc...
PMC5388374
core_pubmed_pmc
Phase I Dose‐Escalation Study of Pilaralisib (SAR245408, XL147) in Combination with Paclitaxel and Carboplatin in Patients with Solid Tumors
Phase I Dose‐Escalation Study of Pilaralisib (SAR245408, XL147) in Combination with Paclitaxel and Carboplatin in Patients with Solid Tumors Abstract Abstract Lessons Learned. Despite involvement of PI3K pathway activation in tumorigenesis of solid tumors, single‐agent PI3K inhibitors have shown modest clinical activit...
PMC2933032
core_pubmed_pmc
Biodistribution and radiation dosimetry of 11 C-labelled docetaxel in cancer patients
Biodistribution and radiation dosimetry of 11 C-labelled docetaxel in cancer patients Abstract Abstract Purpose Docetaxel is an important chemotherapeutic agent used for the treatment of several cancer types. As radiolabelled anticancer agents provide a potential means for personalized treatment planning, docetaxel was...
PMC9692530
core_pubmed_pmc
Analysis of Galangin and Its In Vitro/In Vivo Metabolites via Ultra-High-Performance Liquid Chromatography/Quadrupole Time-of-Flight Mass Spectrometry
Analysis of Galangin and Its In Vitro/In Vivo Metabolites via Ultra-High-Performance Liquid Chromatography/Quadrupole Time-of-Flight Mass Spectrometry Abstract Galangin, a naturally available flavonoid, induces a variety of pharmacological activities and biological effects via several mechanisms. However, in vivo metab...
PMC11292616
core_pubmed_pmc
Usefulness of dalbavancin in early discharge and nonhospitalization. It’s time to throw your heart over the obstacle?
Usefulness of dalbavancin in early discharge and nonhospitalization. It’s time to throw your heart over the obstacle? Abstract ABSTRACT Introduction: Dalbavancin is a semisynthetic lipoglycopeptide long-acting antibiotic approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Its fea...
PMC7765183
core_pubmed_pmc
The Therapeutic Efficacy of Dendrimer and Micelle Formulations for Breast Cancer Treatment
The Therapeutic Efficacy of Dendrimer and Micelle Formulations for Breast Cancer Treatment Abstract Abstract Breast cancer is among the most common types of cancer in women and it is the cause of a high rate of mortality globally. The use of anticancer drugs is the standard treatment approach used for this type of canc...
PMC6966871
core_pubmed_pmc
First-in-human phase I study of BPI-9016M, a dual MET/Axl inhibitor, in patients with non-small cell lung cancer
First-in-human phase I study of BPI-9016M, a dual MET/Axl inhibitor, in patients with non-small cell lung cancer Abstract Background BPI-9016M is a novel small-molecule inhibitor that simultaneously targets both c-Met and AXL tyrosine kinases. This phase I study aimed to determine the maximum tolerated dose (MTD), safe...
PMC12597483
core_pubmed_pmc
Effects of Pemafibrate on Cholesterol Synthesis and Absorption: a Post-Hoc Subgroup Analysis of a Phase 2 Clinical Trial
Effects of Pemafibrate on Cholesterol Synthesis and Absorption: a Post-Hoc Subgroup Analysis of a Phase 2 Clinical Trial Abstract Aim: Recently, we reported that a pemafibrate extended-release (XR) formulation lowered low-density lipoprotein cholesterol (LDL-C) and cholesterol synthesis and absorption markers in a phas...
PMC12034656
core_pubmed_pmc
Acute cannabis intoxication among the paediatric population
Acute cannabis intoxication among the paediatric population Abstract Abstract This narrative review synthesizes the toxicological, clinical and medico-legal aspects of paediatric cannabis intoxication. By providing a comprehensive overview, it aims to inform future research, guide policymaking, and enhance clinical and...
PMC8559552
core_pubmed_pmc
Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?
Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics? Abstract Background: While physiologically based pharmacokinetic (PBPK) models generally predict pharmacokinetics in pregnant...
PMC9326888
core_pubmed_pmc
Food-drug interactions precipitated by fruit juices other than grapefruit juice: An update review
Food-drug interactions precipitated by fruit juices other than grapefruit juice: An update review Abstract Abstract This review addressed drug interactions precipitated by fruit juices other than grapefruit juice based on randomized controlled trials (RCTs). Literature was identified by searching PubMed, Cochrane Libra...
PMC12802879
core_pubmed_pmc
Enhanced antimycobacterial efficacy of simulated inhaled clofazimine versus oral clofazimine in combination with azithromycin and ethambutol in a hollow-fiber system
Enhanced antimycobacterial efficacy of simulated inhaled clofazimine versus oral clofazimine in combination with azithromycin and ethambutol in a hollow-fiber system Abstract Abstract Background and objectives Treatment outcomes in Mycobacterium avium complex pulmonary disease may be improved by adding clofazimine, ins...
PMC5712296
core_pubmed_pmc
Pretargeting of internalizing trastuzumab and cetuximab with a 18 F-tetrazine tracer in xenograft models
Pretargeting of internalizing trastuzumab and cetuximab with a 18 F-tetrazine tracer in xenograft models Abstract Abstract Background Pretargeting-based approaches are being investigated for radioimmunoimaging and therapy applications to reduce the effective radiation burden to the patient. To date, only a few studies ...
PMC7866126
core_pubmed_pmc
DNA-Binding Anticancer Drugs: One Target, Two Actions
DNA-Binding Anticancer Drugs: One Target, Two Actions Abstract Abstract Amsacrine, an anticancer drug first synthesised in 1970 by Professor Cain and colleagues, showed excellent preclinical activity and underwent clinical trial in 1978 under the auspices of the US National Cancer Institute, showing activity against ac...
PMC12771989
core_pubmed_pmc
Therapeutic Drug Monitoring and Point-of-Care Technologies: Opportunities and Current Challenges
Therapeutic Drug Monitoring and Point-of-Care Technologies: Opportunities and Current Challenges Abstract Abstract Background: This review re-evaluates therapeutic drug monitoring (TDM) by comparing the current analytical and subsequent clinical interpretation capabilities of hospital or community medical laboratories ...
PMC11796441
core_pubmed_pmc
Oleanolic Acid Cubic Liquid Crystal Nanoparticle-Based Thermosensitive Gel Attenuates Depression Symptoms in Chronic Unpredictable Mild Stress Rats
Oleanolic Acid Cubic Liquid Crystal Nanoparticle-Based Thermosensitive Gel Attenuates Depression Symptoms in Chronic Unpredictable Mild Stress Rats Abstract Abstract Purpose Major depressive disorder (MDD) is a global health concern. Studies have demonstrated that oleanolic acid (OA) has a regulatory effect on MDD. How...
PMC10472989
core_pubmed_pmc
Pharmacokinetics and tolerability of multiple‐day oral dosing of mycophenolate mofetil in healthy horses
Pharmacokinetics and tolerability of multiple‐day oral dosing of mycophenolate mofetil in healthy horses Abstract Abstract Background Additional efficacious immunomodulatory treatment is needed for the management of immune‐mediated disease in horses. Mycophenolate mofetil (MMF) is an immunosuppressive drug that warrant...
PMC12312149
core_pubmed_pmc
Data-Driven Prediction of Nanoparticle Biodistribution from Physicochemical Descriptors
Data-Driven Prediction of Nanoparticle Biodistribution from Physicochemical Descriptors Abstract Abstract Nanoparticles have gained significant attention in biomedicine, electronics, and environmental science due to their unique physicochemical properties, which critically influence their absorption, distribution, meta...
PMC4835132
core_pubmed_pmc
Clinically relevant genetic variants of drug-metabolizing enzyme and transporter genes detected in Thai children and adolescents with autism spectrum disorder
Clinically relevant genetic variants of drug-metabolizing enzyme and transporter genes detected in Thai children and adolescents with autism spectrum disorder Abstract Single-nucleotide polymorphisms (SNPs) among drug-metabolizing enzymes and transporters (DMETs) influence the pharmacokinetic profile of drugs and exhib...
PMC8207516
core_pubmed_pmc
Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers
Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers Abstract Objectives: Pertuzumab is a monoclonal antibody for the treatment of breast cancer. The aim of this study was to compare the pharmacokinetics, immunogenicity and safety of the test preparati...
PMC7478617
core_pubmed_pmc
Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects
Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects Abstract Abstract The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (...
PMC6524478
core_pubmed_pmc
In vitro activity of the novel oral antimicrobial SMT-571, with a new mechanism of action, against MDR and XDR Neisseria gonorrhoeae : future treatment option for gonorrhoea?
In vitro activity of the novel oral antimicrobial SMT-571, with a new mechanism of action, against MDR and XDR Neisseria gonorrhoeae : future treatment option for gonorrhoea? Abstract Abstract Background Lack of effective treatment of gonorrhoea due to increasing antimicrobial resistance in Neisseria gonorrhoeae is a s...
PMC3595976
core_pubmed_pmc
Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease
Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease Abstract Background Coadministration of mometasone furoate (MF) ...
PMC7081093
core_pubmed_pmc
An Exploratory Phase IIa Study of the PPAR delta/gamma Agonist T3D-959 Assessing Metabolic and Cognitive Function in Subjects with Mild to Moderate Alzheimer’s Disease
An Exploratory Phase IIa Study of the PPAR delta/gamma Agonist T3D-959 Assessing Metabolic and Cognitive Function in Subjects with Mild to Moderate Alzheimer’s Disease Abstract Abstract Background: T3D-959 is a chemically unique, brain penetrant, dual PPAR delta/gamma agonist with 15-fold higher PPAR delta selectivity....
PMC9290462
core_pubmed_pmc
Safety, pharmacokinetics and pharmacodynamics of BI 705564, a highly selective, covalent inhibitor of Bruton's tyrosine kinase, in Phase I clinical trials in healthy volunteers
Safety, pharmacokinetics and pharmacodynamics of BI 705564, a highly selective, covalent inhibitor of Bruton's tyrosine kinase, in Phase I clinical trials in healthy volunteers Abstract Abstract Aims To evaluate the safety, pharmacokinetics and pharmacodynamics of single‐ and multiple‐rising doses (MRDs) of BI 705564 a...
PMC11340219
core_pubmed_pmc
Effect of chronic kidney disease on adverse drug reactions to anti-tubercular treatment: a retrospective cohort study
Effect of chronic kidney disease on adverse drug reactions to anti-tubercular treatment: a retrospective cohort study Abstract Abstract Introduction Patients with chronic kidney disease (CKD) are at increased risk of developing tuberculosis (TB). These patients may also be at higher risk of developing antitubercular tr...
PMC8111447
core_pubmed_pmc
SH-1028, An Irreversible Third-Generation EGFR TKI, Overcomes T790M-Mediated Resistance in Non-Small Cell Lung Cancer
SH-1028, An Irreversible Third-Generation EGFR TKI, Overcomes T790M-Mediated Resistance in Non-Small Cell Lung Cancer Abstract SH-1028 is an irreversible third-generation EGFR TKI. Both SH-1028 and osimertinib have a pyrimidine structure (a typical mutant-selective EGFR TKI structure). Compared with osimertinib, SH-102...
PMC6153505
core_pubmed_pmc
Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis
Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis Abstract Abstract Background Iron deficiency is a common cause of anemia in pediatric patients with hemodialysis-dependent chronic kidney disease (CKD-5HD). Ferric pyrophosphate ci...
PMC9697187
core_pubmed_pmc
An Optimized Bioassay for Screening Combined Anticoronaviral Compounds for Efficacy against Feline Infectious Peritonitis Virus with Pharmacokinetic Analyses of GS-441524, Remdesivir, and Molnupiravir in Cats
An Optimized Bioassay for Screening Combined Anticoronaviral Compounds for Efficacy against Feline Infectious Peritonitis Virus with Pharmacokinetic Analyses of GS-441524, Remdesivir, and Molnupiravir in Cats Abstract Feline infectious peritonitis (FIP) is a fatal disease of cats that currently lacks licensed and affor...
PMC10848080
core_pubmed_pmc
Piperine improves levodopa availability in the 6‐OHDA ‐lesioned rat model of Parkinson's disease by suppressing gut bacterial tyrosine decarboxylase
Piperine improves levodopa availability in the 6‐OHDA ‐lesioned rat model of Parkinson's disease by suppressing gut bacterial tyrosine decarboxylase Abstract Abstract Aim Tyrosine decarboxylase (TDC) presented in the gut‐associated strain Enterococcus faecalis can convert levodopa (L‐dopa) into dopamine (DA), and its i...
PMC7526808
core_pubmed_pmc
Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults
Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults Abstract Super bioavailability (SUBA) itraconazole (S-ITZ), which releases drug in the duodenum, and ...
PMC12889036
core_pubmed_pmc
Efficacy of cefiderocol in murine models of ventilator-associated pneumonia caused by carbapenem-resistant non-fermenting Gram-negative bacilli, with pharmacokinetic evaluation
Efficacy of cefiderocol in murine models of ventilator-associated pneumonia caused by carbapenem-resistant non-fermenting Gram-negative bacilli, with pharmacokinetic evaluation Abstract ABSTRACT Ventilator-associated pneumonia (VAP) caused by carbapenem-resistant non-fermenting Gram-negative bacilli poses a serious cli...
PMC10067098
core_pubmed_pmc
Phase 1 study of DS‐1205c combined with gefitinib for EGFR mutation‐positive non‐small cell lung cancer
Phase 1 study of DS‐1205c combined with gefitinib for EGFR mutation‐positive non‐small cell lung cancer Abstract Abstract Background Tyrosine kinase inhibitors (TKIs) are effective for the treatment of non‐small cell lung cancer (NSCLC) patients with activating mutations of the epidermal growth factor receptor (EGFR), ...
PMC10676321
core_pubmed_pmc
Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist
Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist Abstract Background ASC42 is a non-steroidal farnesoid X receptor agonist currently in clinical development for chronic liver diseases, such as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis ...
PMC3364551
core_pubmed_pmc
Microglial KCa3.1 Channels as a Potential Therapeutic Target for Alzheimer's Disease
Microglial KCa3.1 Channels as a Potential Therapeutic Target for Alzheimer's Disease Abstract There exists an urgent need for new target discovery to treat Alzheimer's disease (AD); however, recent clinical trials based on anti-A β and anti-inflammatory strategies have yielded disappointing results. To expedite new dru...
PMC7008059
core_pubmed_pmc
An HIV-infected Patient with No Serious Adverse Events after Overdosing on Raltegravir
An HIV-infected Patient with No Serious Adverse Events after Overdosing on Raltegravir Abstract Abstract Patients with HIV infection represent a high-risk group for medication overdose because of the high frequency of complicating psychiatric disorders. Raltegravir is well-known for its low frequency of adverse effects...
PMC3458211
core_pubmed_pmc
Quantification of rifampicin in human plasma and cerebrospinal fluid by a highly sensitive and rapid liquid chromatographic–tandem mass spectrometric method
Quantification of rifampicin in human plasma and cerebrospinal fluid by a highly sensitive and rapid liquid chromatographic–tandem mass spectrometric method Abstract Abstract A highly sensitive and rapid liquid chromatography tandem mass spectrometry (LC–MS/MS) method has been developed to measure the levels of the ant...
PMC8758560
core_pubmed_pmc
Repurposing Artemisinin and its Derivatives as Anticancer Drugs: A Chance or Challenge?
Repurposing Artemisinin and its Derivatives as Anticancer Drugs: A Chance or Challenge? Abstract Abstract Cancer has become a global health problem, accounting for one out of six deaths. Despite the recent advances in cancer therapy, there is still an ever-growing need for readily accessible new therapies. The process ...
PMC5133431
core_pubmed_pmc
Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya
Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya Abstract Abstract Background Innovative approaches are needed to complement existing tools for malaria elimination. Ivermectin is a br...
PMC9469700
core_pubmed_pmc
Population pharmacokinetic analysis of etrolizumab in patients with moderately‐to‐severely active ulcerative colitis
Population pharmacokinetic analysis of etrolizumab in patients with moderately‐to‐severely active ulcerative colitis Abstract Abstract Etrolizumab is an IgG1‐humanized monoclonal antibody that specifically targets the β7 subunit of α4β7 and α4Eβ7 integrins, and it has been evaluated for the treatment of moderately‐to‐s...
PMC3660130
core_pubmed_pmc
Profile of once-daily zonisamide as monotherapy for treatment of partial seizures in adults
Profile of once-daily zonisamide as monotherapy for treatment of partial seizures in adults Abstract Epilepsy is one of the most common neurologic disorders, affecting about 50 million people around the world. It is recognized that around 50% of patients with newly diagnosed epilepsy become seizure-free with the first ...
PMC11681640
core_pubmed_pmc
Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat
Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat Abstract Background Excessive submental fat under the chin is a known aesthetic concern because of its negative impact on facial appearance and psychological well-being. AYP-101 is a ne...
PMC9028714
core_pubmed_pmc
Impact of the Genotype and Phenotype of CYP3A and P-gp on the Apixaban and Rivaroxaban Exposure in a Real-World Setting
Impact of the Genotype and Phenotype of CYP3A and P-gp on the Apixaban and Rivaroxaban Exposure in a Real-World Setting Abstract Abstract Apixaban and rivaroxaban are the two most prescribed direct factor Xa inhibitors. With the increased use of DOACs in real-world settings, safety and efficacy concerns have emerged, p...
PMC11015172
core_pubmed_pmc
Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project
Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project Abstract Abstract Introduction Breastfeeding is beneficial for the health of the mother and child. However, at least 50% of postpartum women need pharmacotherapy, and this numbe...
PMC5340925
core_pubmed_pmc
Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia
Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia Abstract Background Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. ...
PMC4235294
core_pubmed_pmc
Analysis of biomarker utility using a PBPK/PD model for carbaryl
Analysis of biomarker utility using a PBPK/PD model for carbaryl Abstract Abstract There are many types of biomarkers; the two common ones are biomarkers of exposure and biomarkers of effect. The utility of a biomarker for estimating exposures or predicting risks depends on the strength of the correlation between bioma...
PMC4212661
core_pubmed_pmc
Time Course of the Changes in Novel Trioxane Antimalarial 99/411 Pharmacokinetics upon Antiepileptic Drugs Co-Administration in SD Rats
Time Course of the Changes in Novel Trioxane Antimalarial 99/411 Pharmacokinetics upon Antiepileptic Drugs Co-Administration in SD Rats Abstract Abstract Objective . The study aimed to evaluate the influences of coadministration of antiepileptic drugs (AEDs) on an antimalarial candidate 99/411 pharmacokinetic (PK) prof...
PMC9740939
core_pubmed_pmc
A Network-Pharmacology-Combined Integrated Pharmacokinetic Strategy to Investigate the Mechanism of Potential Liver Injury due to Polygonum multiflorum
A Network-Pharmacology-Combined Integrated Pharmacokinetic Strategy to Investigate the Mechanism of Potential Liver Injury due to Polygonum multiflorum Abstract Polygonum multiflorum (PM) has been used as a tonic and anti-aging remedy for centuries in Asian countries. However, its application in the clinic has been hin...
PMC10449733
core_pubmed_pmc
Predicting [ 177 Lu]Lu-HA-DOTATATE kidney and tumor accumulation based on [ 68 Ga]Ga-HA-DOTATATE diagnostic imaging using semi-physiological population pharmacokinetic modeling
Predicting [ 177 Lu]Lu-HA-DOTATATE kidney and tumor accumulation based on [ 68 Ga]Ga-HA-DOTATATE diagnostic imaging using semi-physiological population pharmacokinetic modeling Abstract Abstract Background Prediction of [ 177 Lu]Lu-HA-DOTATATE kidney and tumor uptake based on diagnostic [ 68 Ga]Ga-HA-DOTATATE imaging w...
PMC10933797
core_pubmed_pmc
Effects of Enteric-Coated Formulation of Sodium Bicarbonate on Bicarbonate Absorption and Gastrointestinal Discomfort
Effects of Enteric-Coated Formulation of Sodium Bicarbonate on Bicarbonate Absorption and Gastrointestinal Discomfort Abstract Sodium bicarbonate is used as an ergogenic supplement to enhance people’s performances in various exercises. This study aimed to evaluate the effects of intestinal delivery of sodium bicarbonat...
PMC7589583
core_pubmed_pmc
Hydroxylation of Antitubercular Drug Candidate, SQ109, by Mycobacterial Cytochrome P450
Hydroxylation of Antitubercular Drug Candidate, SQ109, by Mycobacterial Cytochrome P450 Abstract Abstract Spreading of the multidrug-resistant (MDR) strains of the one of the most harmful pathogen Mycobacterium tuberculosis (Mtb) generates the need for new effective drugs. SQ109 showed activity against resistant Mtb an...
PMC7663239
core_pubmed_pmc
Naturally Occurring Calanolides: Occurrence, Biosynthesis, and Pharmacological Properties Including Therapeutic Potential
Naturally Occurring Calanolides: Occurrence, Biosynthesis, and Pharmacological Properties Including Therapeutic Potential Abstract Calanolides are tetracyclic 4-substituted dipyranocoumarins. Calanolide A, isolated from the leaves and twigs of Calophyllum lanigerum var. austrocoriaceum (Whitmore) P. F. Stevens, is the ...
PMC8494515
core_pubmed_pmc
A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects
A Practical, One-Clinic Visit Protocol for Pharmacokinetic Profile Generation with the ADVATE myPKFiT Dosing Tool in Severe Hemophilia A Subjects Abstract Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72-hour washout and 5 to 11 timed blood samples. A no-washout, sin...
PMC12359200
core_pubmed_pmc
Saliva Based Clozapine Therapeutic Drug Monitoring: A Systematic Review
Saliva Based Clozapine Therapeutic Drug Monitoring: A Systematic Review Abstract ABSTRACT Clozapine is superior in the treatment of treatment‐refractory schizophrenia but requires therapeutic drug monitoring (TDM) due to its unpredictable pharmacokinetics and dose‐dependent side effects. This systematic review evaluate...
PMC5953983
core_pubmed_pmc
Population pharmacokinetics and exposure–response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia
Population pharmacokinetics and exposure–response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia Abstract Evolocumab, a novel human monoclonal antibody, inhibits proprotein convertase subtilisin/kexin type 9, a protein that targets low-density lipoprotein-cholesterol...
PMC10719473
core_pubmed_pmc
Protocol of the IntenSify‐Trial: An open‐label phase I trial of the CYP3A inhibitor cobicistat and the cytostatics gemcitabine and nab‐paclitaxel in patients with advanced stage or metastatic pancreatic ductal adenocarcinoma to evaluate the combination's pharmacokinetics, safety, and efficacy
Protocol of the IntenSify‐Trial: An open‐label phase I trial of the CYP3A inhibitor cobicistat and the cytostatics gemcitabine and nab‐paclitaxel in patients with advanced stage or metastatic pancreatic ductal adenocarcinoma to evaluate the combination's pharmacokinetics, safety, and efficacy Abstract Abstract Expressi...
PMC11543921
core_pubmed_pmc
Preclinical validation of human recombinant glutamate-oxaloacetate transaminase for the treatment of acute ischemic stroke
Preclinical validation of human recombinant glutamate-oxaloacetate transaminase for the treatment of acute ischemic stroke Abstract Summary The blood enzyme glutamate-oxaloacetate transaminase (GOT) has been postulated as an effective therapeutic to protect the brain during stroke. To demonstrate its potential clinical...
PMC7016293
core_pubmed_pmc
Optimized functional and structural design of dual-target LMRAP, a bifunctional fusion protein with a 25-amino-acid antitumor peptide and GnRH Fc fragment
Optimized functional and structural design of dual-target LMRAP, a bifunctional fusion protein with a 25-amino-acid antitumor peptide and GnRH Fc fragment Abstract Abstract To develop fusion protein of a GnRH Fc fragment and the integrin targeting AP25 antitumor peptide for GnRH receptor-expressing cancer therapy. The ...