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PMC11616965
core_pubmed_pmc
Clinical pearls for the management of duloxetine patients with medical comorbidities
Clinical pearls for the management of duloxetine patients with medical comorbidities Abstract The effective use of duloxetine can be complicated by acute kidney injury, acute and/or chronic hepatic dysfunction, dysphagia, enteral nutrition, and common pharmacokinetic interactions. This article aimed to review the pharm...
PMC9068598
core_pubmed_pmc
Immunobiology of tubercle bacilli and prospects of immunomodulatory drugs to tackle tuberculosis (TB) and other non-tubercular mycobacterial infections
Immunobiology of tubercle bacilli and prospects of immunomodulatory drugs to tackle tuberculosis (TB) and other non-tubercular mycobacterial infections Abstract The COVID-19 pandemic has set back progress made on antimicrobial resistance (AMR). Without urgent re-focus, we risk slowing down drug discovery and providing ...
PMC12390456
core_pubmed_pmc
Comparison of Intravenous and Oral Meloxicam Pharmacokinetics in Female and Male Saanen Goats
Comparison of Intravenous and Oral Meloxicam Pharmacokinetics in Female and Male Saanen Goats Abstract Simple Summary Meloxicam is a medication commonly used in animals to reduce pain and inflammation, helping them recover more comfortably after illness or surgery. However, the way this medication is processed in the b...
PMC4810081
core_pubmed_pmc
Venetoclax (ABT-199) Might Act as a Perpetrator in Pharmacokinetic Drug–Drug Interactions
Venetoclax (ABT-199) Might Act as a Perpetrator in Pharmacokinetic Drug–Drug Interactions Abstract Abstract Venetoclax (ABT-199) represents a specific B-cell lymphoma 2 (Bcl-2) inhibitor that is currently under development for the treatment of lymphoid malignancies. So far, there is no published information on its inte...
PMC12294483
core_pubmed_pmc
Laser-Induced Dimeric Photoproducts of Chlorpromazine: LC-MS Identification and Molecular Docking Evidence of Enhanced Anticancer Potential
Laser-Induced Dimeric Photoproducts of Chlorpromazine: LC-MS Identification and Molecular Docking Evidence of Enhanced Anticancer Potential Abstract Breast cancer treatments, such as chemotherapy, radiation, and surgery, often face significant limitations, highlighting the need for more effective and targeted therapies...
PMC7520415
core_pubmed_pmc
Comparison of covariate selection methods with correlated covariates: prior information versus data information, or a mixture of both?
Comparison of covariate selection methods with correlated covariates: prior information versus data information, or a mixture of both? Abstract Abstract The inclusion of covariates in population models during drug development is a key step to understanding drug variability and support dosage regimen proposal, but high ...
PMC7359987
core_pubmed_pmc
The Roles of Common Variation and Somatic Mutation in Cancer Pharmacogenomics
The Roles of Common Variation and Somatic Mutation in Cancer Pharmacogenomics Abstract Abstract Cancer pharmacogenomics is the science concerned with understanding genetic alterations and its effects on the pharmacokinetics and pharmacodynamics of anti-cancer drugs, with the aim to provide cancer patients with the prec...
PMC6251219
core_pubmed_pmc
AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial Abstract Background Cryptococcal meningitis (CM) is a major cause of mortality in HIV programmes in Africa ...
PMC4258503
core_pubmed_pmc
Enantiomer-selective pharmacokinetics, oral bioavailability, and sex effects of various alpha-lipoic acid dosage forms
Enantiomer-selective pharmacokinetics, oral bioavailability, and sex effects of various alpha-lipoic acid dosage forms Abstract The present study aimed to examine the enantiomer-selective pharmacokinetics (PK), relative bioavailability (F rel ), and sex effects of various oral dosage forms of racemic alpha-lipoic acid ...
PMC9248796
core_pubmed_pmc
A trial design to maximize knowledge of the effects of rodatristat ethyl in the treatment of pulmonary arterial hypertension (ELEVATE 2)
A trial design to maximize knowledge of the effects of rodatristat ethyl in the treatment of pulmonary arterial hypertension (ELEVATE 2) Abstract Abstract Serotonin plays a key role in the development and maintenance of the pathobiology associated with pulmonary arterial hypertension (PAH). Platelet‐driven and locally ...
PMC11469894
core_pubmed_pmc
Vesicle-based formulations for pain treatment: a narrative review
Vesicle-based formulations for pain treatment: a narrative review Abstract Vesicle-based drug delivery offers promising solutions by enhancing efficacy, reducing toxicity, enabling targeted pain relief, and overcoming the limitations of current treatments. Abstract Pain, a complex and debilitating condition, necessitat...
PMC4429480
core_pubmed_pmc
Simultaneous quantification of proposed anti-malarial combination comprising of lumefantrine and CDRI 97–78 in rat plasma using the HPLC–ESI-MS/MS method: application to drug interaction study
Simultaneous quantification of proposed anti-malarial combination comprising of lumefantrine and CDRI 97–78 in rat plasma using the HPLC–ESI-MS/MS method: application to drug interaction study Abstract Background Lumefantrine is the mainstay of anti-malarial combination therapy in most endemic countries presently. Howe...
PMC3506523
core_pubmed_pmc
DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic
DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic Abstract Background The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antif...
PMC9656453
core_pubmed_pmc
A Rapid and Sensitive LC−MS/MS Method for the Quantitation of Physalin A with Special Consideration to Chemical Stability in Rat Plasma: Application to a Pharmacokinetic Study
A Rapid and Sensitive LC−MS/MS Method for the Quantitation of Physalin A with Special Consideration to Chemical Stability in Rat Plasma: Application to a Pharmacokinetic Study Abstract Abstract Physalin A is a promising natural product with excellent anti-inflammatory and anti-tumor activities. However, the pharmacokin...
PMC8506700
core_pubmed_pmc
Effects of voriconazole on population pharmacokinetics and optimization of the initial dose of tacrolimus in children with chronic granulomatous disease undergoing hematopoietic stem cell transplantation
Effects of voriconazole on population pharmacokinetics and optimization of the initial dose of tacrolimus in children with chronic granulomatous disease undergoing hematopoietic stem cell transplantation Abstract Background This study aimed to explore the effects of voriconazole on population pharmacokinetics and optim...
PMC12697364
core_pubmed_pmc
Regulation of Renal Transporters by Pro-inflammatory Cytokines in Human Proximal Tubular Epithelial Cells: Identification of the Perpetrator and Mechanisms
Regulation of Renal Transporters by Pro-inflammatory Cytokines in Human Proximal Tubular Epithelial Cells: Identification of the Perpetrator and Mechanisms Abstract Abstract Introduction Infection and inflammation elevate circulating pro-inflammatory cytokines that can affect renal drug clearance. Accordingly, we sough...
PMC6661551
core_pubmed_pmc
Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)
Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC) Abstract Abstract Introduction Repetitive elect...
PMC10304707
core_pubmed_pmc
Gut Microbiota-Mediated Pharmacokinetic Drug–Drug Interactions between Mycophenolic Acid and Trimethoprim-Sulfamethoxazole in Humans
Gut Microbiota-Mediated Pharmacokinetic Drug–Drug Interactions between Mycophenolic Acid and Trimethoprim-Sulfamethoxazole in Humans Abstract Abstract Mycophenolic acid (MPA) and trimethoprim-sulfamethoxazole (TMP-SMX) are commonly prescribed together in certain groups of patients, including solid organ transplant reci...
PMC4335020
core_pubmed_pmc
Single Oral Dose Pharmacokinetics of Decursin and Decursinol Angelate in Healthy Adult Men and Women
Single Oral Dose Pharmacokinetics of Decursin and Decursinol Angelate in Healthy Adult Men and Women Abstract The ethanol extract of Angelica gigas Nakai (AGN) root has promising anti-cancer and other bioactivities in rodent models. It is currently believed that the pyranocoumarin isomers decursin (D) and decursinol an...
PMC12524999
core_pubmed_pmc
Pharmacokinetic Alterations in Patients with Chronic Heart Failure: A Systematic Review
Pharmacokinetic Alterations in Patients with Chronic Heart Failure: A Systematic Review Abstract (1) Chronic heart failure (CHF) is a typical component of the polymorbid profile of an elderly patient. The aim of this systematic review was to search for data from pharmacokinetic (PK) studies of any drugs in patients wit...
PMC7522823
core_pubmed_pmc
Vancomycin Dosing Practices among Critical Care Pharmacists: A Survey of Society of Critical Care Medicine Pharmacists
Vancomycin Dosing Practices among Critical Care Pharmacists: A Survey of Society of Critical Care Medicine Pharmacists Abstract Abstract Introduction: Critically ill patients and their pharmacokinetics present complexities often not considered by consensus guidelines from the American Society of Health-System Pharmacis...
PMC10674389
core_pubmed_pmc
A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy
A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy Abstract The purpose of this literature review is to comprehensively summarize changes in the expression of phase II drug-metabolizing enzymes and drug transporters in both the pregnant woman and the pla...
PMC12659884
core_pubmed_pmc
Comparative evaluation of the effect of various transdermal patches and oral nonsteroidal anti-inflammatory drugs on postoperative endodontic pain and quality of life – A placebo-controlled randomized clinical trial
Comparative evaluation of the effect of various transdermal patches and oral nonsteroidal anti-inflammatory drugs on postoperative endodontic pain and quality of life – A placebo-controlled randomized clinical trial Abstract Aim: To evaluate the efficacy of preemptive ketoprofen transdermal patch (KTP) administration a...
PMC6038347
core_pubmed_pmc
Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL)
Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL) Abstract Abstract Background A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy ...
PMC12357786
core_pubmed_pmc
Population pharmacokinetic and exposure-response study of a novel anti-tuberculosis drug to inform its dosage design in phase III clinical trial
Population pharmacokinetic and exposure-response study of a novel anti-tuberculosis drug to inform its dosage design in phase III clinical trial Abstract Although bedaquiline (BDQ) received conditional approval for multi-drug resistance tuberculosis (MDR-TB), a black box warning was added due to QT prolongation risk. W...
PMC12867113
core_pubmed_pmc
Neuroprotective effects of kojic acid and nano-kojic acid in experimental brain ischemia induced by bilateral common carotid artery occlusion
Neuroprotective effects of kojic acid and nano-kojic acid in experimental brain ischemia induced by bilateral common carotid artery occlusion Abstract Objective(s): Brain ischemia remains a leading cause of death and neurological disability worldwide, with current treatments limited by narrow therapeutic windows and in...
PMC7517694
core_pubmed_pmc
Hydroxychloroquine levels in patients with systemic lupus erythematosus: whole blood is preferable but serum levels also detect non-adherence
Hydroxychloroquine levels in patients with systemic lupus erythematosus: whole blood is preferable but serum levels also detect non-adherence Abstract Abstract Background Hydroxychloroquine (HCQ) levels can be measured in both serum and whole blood. No cut-off point for non-adherence has been established in serum nor h...
PMC3782471
core_pubmed_pmc
In Silico and In Vivo Anti-Malarial Studies of 18β Glycyrrhetinic Acid from Glycyrrhiza glabra
In Silico and In Vivo Anti-Malarial Studies of 18β Glycyrrhetinic Acid from Glycyrrhiza glabra Abstract Abstract Malaria is one of the most prevailing fatal diseases causing between 1.2 and 2.7 million deaths all over the world each year. Further, development of resistance against the frontline anti-malarial drugs has ...
PMC3697038
core_pubmed_pmc
An Approach for Identifiability of Population Pharmacokinetic–Pharmacodynamic Models
An Approach for Identifiability of Population Pharmacokinetic–Pharmacodynamic Models Abstract Abstract Mathematical models are routinely used in clinical pharmacology to study the pharmacokinetic and pharmacodynamic properties of a drug in the body. Identifiability of these models is an important requirement for the su...
PMC3598979
core_pubmed_pmc
Pharmacokinetic study on pradofloxacin in the dog – Comparison of serum analysis, ultrafiltration and tissue sampling after oral administration
Pharmacokinetic study on pradofloxacin in the dog – Comparison of serum analysis, ultrafiltration and tissue sampling after oral administration Abstract Background Pradofloxacin, a newly developed 8-cyano-fluoroquinolone, show enhanced activity against Gram-positive organisms and anaerobes to treat canine and feline ba...
PMC7699451
core_pubmed_pmc
Pharmacokinetic/Pharmacodynamic Interactions Between Evogliptin and Glimepiride in Healthy Male Subjects
Pharmacokinetic/Pharmacodynamic Interactions Between Evogliptin and Glimepiride in Healthy Male Subjects Abstract Purpose Evogliptin, a dipeptidyl peptidase-4 inhibitor, and glimepiride, a sulfonylurea, are used to treat type 2 diabetes mellitus. In this study, we aimed to evaluate the pharmacokinetic (PK) and pharmaco...
PMC11657253
core_pubmed_pmc
A new strategy for monitoring of direct oral anticoagulants in patients with cyanotic and complex congenital heart disease
A new strategy for monitoring of direct oral anticoagulants in patients with cyanotic and complex congenital heart disease Abstract Background Patients with congenital heart disease (CHD) often require an oral anticoagulation. Vitamin K antagonists (VKA) are the standard treatment, however, an increased hematocrit in p...
PMC4435065
core_pubmed_pmc
A 30-years Review on Pharmacokinetics of Antibiotics: Is the Right Time for Pharmacogenetics?
A 30-years Review on Pharmacokinetics of Antibiotics: Is the Right Time for Pharmacogenetics? Abstract Abstract Drug bioavailability may vary greatly amongst individuals, affecting both efficacy and toxicity: in humans, genetic variations account for a relevant proportion of such variability. In the last decade the use...
PMC5896440
core_pubmed_pmc
Evaluation of Nicotine Pharmacokinetics and Subjective Effects following Use of a Novel Nicotine Delivery System
Evaluation of Nicotine Pharmacokinetics and Subjective Effects following Use of a Novel Nicotine Delivery System Abstract Abstract Introduction Novel nicotine delivery systems represent an evolving part of the tobacco harm reduction strategy. The pharmacokinetic (PK) profile of nicotine delivered by P3L, a pulmonary ni...
PMC3324841
core_pubmed_pmc
Safety of recombinant human platelet-derived growth factor-BB in Augment ® Bone Graft
Safety of recombinant human platelet-derived growth factor-BB in Augment ® Bone Graft Abstract This article discusses nonclinical and clinical data regarding the safety of recombinant human platelet-derived growth factor-BB as a component of the Augment ® Bone Graft ( Augment ). Augment is a bone graft substitute inten...
PMC12888888
core_pubmed_pmc
Pharmacokinetics/pharmacodynamics of ceftazidime-avibactam in critically ill adult patients receiving continuous renal replacement therapy
Pharmacokinetics/pharmacodynamics of ceftazidime-avibactam in critically ill adult patients receiving continuous renal replacement therapy Abstract ABSTRACT Ceftazidime-avibactam (CAZ-AVI), a novel antibiotic, is effective in treating infections caused by carbapenem-resistant Gram-negative bacteria. However, in patient...
PMC9274542
core_pubmed_pmc
TransCon IL-2 β/γ: a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer
TransCon IL-2 β/γ: a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer Abstract Background Recombinant interleukin-2 (IL-2, aldesleukin) is an approved cancer immunotherapy but...
PMC9345835
core_pubmed_pmc
Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma
Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma Abstract Background Teclistamab (JNJ-64007957), a B-cell maturation antigen × CD3 bispecific antibody, displayed potent T-cell–mediated cytotoxicity of multiple myeloma cells in preclinical studies. Objective A firs...
PMC9866963
core_pubmed_pmc
Partitioning of Persistent Organic Pollutants between Adipose Tissue and Serum in Human Studies
Partitioning of Persistent Organic Pollutants between Adipose Tissue and Serum in Human Studies Abstract Blood is the most widely used matrix for biomonitoring of persistent organic pollutants (POPs). It is assumed that POPs are homogenously distributed within body lipids at steady state; however, the variability under...
PMC10218858
core_pubmed_pmc
Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy?
Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy? Abstract Follicle-stimulating hormone (FSH), together with luteinizing hormone (LH) and human chorionic gonadotropin (hCG), plays a fundamental role in human reproduction. The discovery of FSH and other gonadotropins was a definin...
PMC6742937
core_pubmed_pmc
Prediction of Human Pharmacokinetics of Antibody–Drug Conjugates From Nonclinical Data
Prediction of Human Pharmacokinetics of Antibody–Drug Conjugates From Nonclinical Data Abstract Prediction of human pharmacokinetics (PK) based on preclinical information for antibody–drug conjugates (ADCs) provide important insight into first‐in‐human (FIH) study design. This retrospective analysis was conducted to id...
PMC5475299
core_pubmed_pmc
In vitro inhibition of lipid accumulation induced by oleic acid and in vivo pharmacokinetics of chitosan microspheres (CTMS) and chitosan-capsaicin microspheres (CCMS)
In vitro inhibition of lipid accumulation induced by oleic acid and in vivo pharmacokinetics of chitosan microspheres (CTMS) and chitosan-capsaicin microspheres (CCMS) Abstract ABSTRACT Chitosan and capsaicin are compounds extracted from natural products and have been indicated to lower body weight and prevent fatty li...
PMC6032820
core_pubmed_pmc
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective Abstract This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission base...
PMC12046392
core_pubmed_pmc
Population pharmacokinetics and exposure–response relationship of the antituberculosis drug BTZ-043
Population pharmacokinetics and exposure–response relationship of the antituberculosis drug BTZ-043 Abstract Abstract Introduction BTZ-043 is a first-in-class benzothiazinone for the treatment of TB with demonstrated early bactericidal activity. BTZ-043 is metabolized into two major metabolites: M1 and M2. The aim of t...
PMC11941075
core_pubmed_pmc
Molecular Docking and Pharmacological In Silico Evaluation of Camptothecin and Related Ligands as Promising HER2-Targeted Therapies for Breast Cancer
Molecular Docking and Pharmacological In Silico Evaluation of Camptothecin and Related Ligands as Promising HER2-Targeted Therapies for Breast Cancer Abstract Abstract Breast cancer is one of the leading causes of cancer-related mortality in women worldwide, highlighting the importance of effective therapies. This stud...
PMC8278299
core_pubmed_pmc
Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data
Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data Abstract Abstract Background The strengthening or substitution of intravenous cy...
PMC6373187
core_pubmed_pmc
Oral administration of irinotecan in patients with solid tumors: an open-label, phase I, dose escalating study evaluating safety, tolerability and pharmacokinetics
Oral administration of irinotecan in patients with solid tumors: an open-label, phase I, dose escalating study evaluating safety, tolerability and pharmacokinetics Abstract Abstract Background Oral drug formulations have several advantages compared to intravenous formulation. Apart from patient convenience and favorabl...
PMC7179958
core_pubmed_pmc
Prediction of Clinical Transporter‐Mediated Drug–Drug Interactions via Comeasurement of Pitavastatin and Eltrombopag in Human Hepatocyte Models
Prediction of Clinical Transporter‐Mediated Drug–Drug Interactions via Comeasurement of Pitavastatin and Eltrombopag in Human Hepatocyte Models Abstract Abstract A structurally identifiable micro‐rate constant mechanistic model was used to describe the interaction between pitavastatin and eltrombopag, with improved goo...
PMC8563584
core_pubmed_pmc
Experience of a Strategy Including CYP2C19 Preemptive Genotyping Followed by Therapeutic Drug Monitoring of Voriconazole in Patients Undergoing Allogenic Hematopoietic Stem Cell Transplantation
Experience of a Strategy Including CYP2C19 Preemptive Genotyping Followed by Therapeutic Drug Monitoring of Voriconazole in Patients Undergoing Allogenic Hematopoietic Stem Cell Transplantation Abstract Abstract Many factors have been described to contribute to voriconazole (VCZ) interpatient variability in plasma conc...
PMC9961155
core_pubmed_pmc
Ventilator-Associated Pneumonia in COVID-19 Patients Admitted in Intensive Care Units: Relapse, Therapeutic Failure and Attributable Mortality—A Multicentric Observational Study from the OutcomeRea Network
Ventilator-Associated Pneumonia in COVID-19 Patients Admitted in Intensive Care Units: Relapse, Therapeutic Failure and Attributable Mortality—A Multicentric Observational Study from the OutcomeRea Network Abstract Abstract Introduction: Ventilator-associated pneumonia (VAP) incidence is high among critically ill COVID...
PMC11078291
core_pubmed_pmc
Effect of Bedaquiline and Delamanid Pharmacokinetics on Sputum Culture Conversion and Adverse Events in Drug-Resistant Tuberculosis
Effect of Bedaquiline and Delamanid Pharmacokinetics on Sputum Culture Conversion and Adverse Events in Drug-Resistant Tuberculosis Abstract Abstract Background: Pharmacokinetic studies of bedaquiline and delamanid in patients with pre-extensively drug-resistant tuberculosis (pre-XDR TB) will help in the optimization o...
PMC6124791
core_pubmed_pmc
Clinical utility of fulvestrant in the treatment of breast cancer: a report on the emerging clinical evidence
Clinical utility of fulvestrant in the treatment of breast cancer: a report on the emerging clinical evidence Abstract Abstract Fulvestrant is the first selective estrogen receptor (ER) downregulator available in clinical practice. It is a pure antiestrogen with no agonistic effects, leading to degradation of ER alpha,...
PMC4231999
core_pubmed_pmc
Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV-1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily
Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV-1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily Abstract Objectives Antiretroviral therapy during pregnancy is recommended to reduce the risk of mother-to-child transmission of HIV and for maternal care man...
PMC8868358
core_pubmed_pmc
The Role of Colistin in the Era of New β-Lactam/β-Lactamase Inhibitor Combinations
The Role of Colistin in the Era of New β-Lactam/β-Lactamase Inhibitor Combinations Abstract With the current crisis related to the emergence of carbapenem-resistant Gram-negative bacteria (CR-GNB), classical treatment approaches with so-called “old-fashion antibiotics” are generally unsatisfactory. Newly approved β-lac...
PMC4324411
core_pubmed_pmc
A Bayesian decision support tool for efficient dose individualization of warfarin in adults and children
A Bayesian decision support tool for efficient dose individualization of warfarin in adults and children Abstract Background Warfarin is the most widely prescribed anticoagulant for the prevention and treatment of thromboembolic events. Although highly effective, the use of warfarin is limited by a narrow therapeutic r...
PMC12801910
core_pubmed_pmc
Efficacy and safety of Janus kinase 1/2 inhibitor KL130008 in active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase II trial
Efficacy and safety of Janus kinase 1/2 inhibitor KL130008 in active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase II trial Abstract Abstract Background KL130008 is a selective Janus kinase 1/2 inhibitor with encouraging preclinical efficacy. Phase I trials in healthy volunteers and patient...
PMC10192552
core_pubmed_pmc
P-glycoprotein efflux transporter: a key to pharmacokinetic modeling for methadone clearance in fetuses
P-glycoprotein efflux transporter: a key to pharmacokinetic modeling for methadone clearance in fetuses Modeling In vivo animal models As a synthetic opioid agonist, methadone is mainly eliminated via hepatic metabolism by CYP 2B6, and partly by CYP 3A4 ( Garrido and Trocóniz, 1999 ; Kharasch, 2017 ). Its concentration...
PMC11179705
core_pubmed_pmc
Translational kinetic‐pharmacodynamics of mRNA‐6231, an investigational mRNA therapeutic encoding mutein interleukin‐2
Translational kinetic‐pharmacodynamics of mRNA‐6231, an investigational mRNA therapeutic encoding mutein interleukin‐2 Abstract Abstract Regulatory T cells (T regs ) are essential for maintaining immune homeostasis by serving as negative regulators of adaptive immune system effector cell responses. Reduced production o...
PMC8309133
core_pubmed_pmc
Pharmacokinetics and Bioavailability of Carprofen in Rainbow Trout ( Oncorhynchus mykiss ) Broodstock
Pharmacokinetics and Bioavailability of Carprofen in Rainbow Trout ( Oncorhynchus mykiss ) Broodstock Abstract Abstract The aim of this study was to determine the pharmacokinetics of carprofen following intravenous (IV), intramuscular (IM) and oral routes to rainbow trout ( Oncorhynchus mykiss ) broodstock at temperatu...
PMC12639577
core_pubmed_pmc
Long lasting complement neutralisation by RAY121, an engineered anti-C1s antibody with C1q displacement function
Long lasting complement neutralisation by RAY121, an engineered anti-C1s antibody with C1q displacement function Abstract Summary Background Antibody drugs blocking the complement classical pathway (CP) often require frequent intravenous administration to overcome the high abundance or rapid turnover of complement prot...
PMC9492280
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Stem Cell Therapies for Chronic Liver Diseases: Progress and Challenges
Stem Cell Therapies for Chronic Liver Diseases: Progress and Challenges Abstract Abstract Chronic liver diseases have become a significant health issue worldwide and urgently require the development of novel therapeutic approaches, in addition to liver transplantation. Recent clinical and preclinical studies have shown...
PMC10720486
core_pubmed_pmc
Safety, tolerability, and pharmacokinetics of ibrexafungerp in healthy Chinese subjects: a randomized, double-blind, placebo-controlled phase 1 trial
Safety, tolerability, and pharmacokinetics of ibrexafungerp in healthy Chinese subjects: a randomized, double-blind, placebo-controlled phase 1 trial Abstract ABSTRACT Ibrexafungerp (code name in China: HS-10366) is a first-in-class and orally active triterpenoid antifungal agent with broad antifungal activity against ...
PMC10082376
core_pubmed_pmc
Single-time-point estimation of absorbed doses in PRRT using a non-linear mixed-effects model
Single-time-point estimation of absorbed doses in PRRT using a non-linear mixed-effects model Abstract Introduction Estimation of accurate time-integrated activity coefficients (TIACs) and radiation absorbed doses (ADs) is desirable for treatment planning in peptide-receptor radionuclide therapy (PRRT). This study aime...
PMC5574006
core_pubmed_pmc
Population Pharmacokinetics of Brentuximab Vedotin in Patients With CD30‐Expressing Hematologic Malignancies
Population Pharmacokinetics of Brentuximab Vedotin in Patients With CD30‐Expressing Hematologic Malignancies Abstract Abstract Brentuximab vedotin, a CD30‐directed antibody‐drug conjugate (ADC), is approved for treating certain patients with CD30‐expressing hematologic malignancies. Its primary mechanism of action is t...
PMC10582659
core_pubmed_pmc
An innovative phase I study in healthy subjects to determine the mass balance, elimination, metabolism, and absolute bioavailability of mitapivat
An innovative phase I study in healthy subjects to determine the mass balance, elimination, metabolism, and absolute bioavailability of mitapivat Abstract Abstract Mitapivat, a first‐in‐class, oral, small‐molecule, allosteric activator of the red blood cell‐specific form of pyruvate kinase (PKR), was approved for the t...
PMC12638810
core_pubmed_pmc
Leveraging artificial intelligence in antibody-drug conjugate development: from target identification to clinical translation in oncology
Leveraging artificial intelligence in antibody-drug conjugate development: from target identification to clinical translation in oncology Abstract Abstract Artificial intelligence (AI) is opening new frontiers in the development of antibody-drug conjugates (ADCs), offering unprecedented opportunities for precision ther...
PMC7439710
core_pubmed_pmc
Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab
Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab Abstract Abstract Background BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies i...
PMC12062087
core_pubmed_pmc
Therapeutic peptides: chemical strategies fortify peptides for enhanced disease treatment efficacy
Therapeutic peptides: chemical strategies fortify peptides for enhanced disease treatment efficacy Abstract Therapeutic peptides, as a unique form of medication composed of orderly arranged sequences of amino acids, are valued for their high affinity, specificity, low immunogenicity, and economical production costs. Cu...
PMC12727275
core_pubmed_pmc
Phase Ia/b Multicenter Study of BPM31510IV Targeting Mitochondrial Metabolism/Warburg Effect as Monotherapy and Combination Chemotherapy in Solid Tumor Patients
Phase Ia/b Multicenter Study of BPM31510IV Targeting Mitochondrial Metabolism/Warburg Effect as Monotherapy and Combination Chemotherapy in Solid Tumor Patients Abstract Abstract Purpose: BPM31510IV, a highly bioavailable intravenously administered coenzyme Q 10 (CoQ 10 ) formulation, was evaluated in a phase Ia/Ib stu...
PMC10658303
core_pubmed_pmc
Pharmacokinetic and pharmacodynamic drug-drug interaction of Nomilin with atorvastatin in hyperlipidemic mice
Pharmacokinetic and pharmacodynamic drug-drug interaction of Nomilin with atorvastatin in hyperlipidemic mice Abstract Abstract Atorvastatin (Atv) is widely used to lower cholesterol levels and treat hyperlipidemia in clinical application. Nomilin (Nom) is a kind of limonoids, which is found and isolated from the citru...
PMC11780246
core_pubmed_pmc
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses Abstract Exposure-response (ER) analyses are routinely performed as part of model-informed drug development to evaluate the risk-to-benefit ratio for dose selection, justification, and confirmation. For logistic regression ...
PMC12510943
core_pubmed_pmc
Enhancing therapeutic antibody profiling: orthogonal strategies for stability and quality assessment
Enhancing therapeutic antibody profiling: orthogonal strategies for stability and quality assessment Abstract Abstract Today, a variety of multivalent antibody formats can be engineered, offering significant flexibility for therapeutic and diagnostic approaches. While unmodified antibodies have evolved to be structural...
PMC10477696
core_pubmed_pmc
Evaluation of polymyxin B AUC/MIC ratio for dose optimization in patients with carbapenem-resistant Klebsiella pneumoniae infection
Evaluation of polymyxin B AUC/MIC ratio for dose optimization in patients with carbapenem-resistant Klebsiella pneumoniae infection Abstract Polymyxin B has been used as a last-line therapy for the treatment of carbapenem-resistant gram-negative bacterial infection. The pharmacokinetic/pharmacodynamic index (AUC/MIC) o...
PMC6312694
core_pubmed_pmc
Formulation and clinical investigation of optimized vinpocetine lyoplant-tabs: new strategy in development of buccal solid dosage form
Formulation and clinical investigation of optimized vinpocetine lyoplant-tabs: new strategy in development of buccal solid dosage form Abstract Abstract Background This work aimed to develop a new solid dosage formulation of vinpocetine (VPN) in the form of buccal freeze-dried pullulan-based tablets (lyoplant-tabs) loa...
PMC7017074
core_pubmed_pmc
Krebs Cycle Intermediate-Modified Carbonate Apatite Nanoparticles Drastically Reduce Mouse Tumor Burden and Toxicity by Restricting Broad Tissue Distribution of Anticancer Drugs
Krebs Cycle Intermediate-Modified Carbonate Apatite Nanoparticles Drastically Reduce Mouse Tumor Burden and Toxicity by Restricting Broad Tissue Distribution of Anticancer Drugs Abstract The morphology, size, and surface area of nanoparticles (NPs), with the existence of functional groups on their surface, contribute t...
PMC4166693
core_pubmed_pmc
Pharmacological characteristics of a novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)
Pharmacological characteristics of a novel, recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) Abstract Abstract Background Recombinant factor VIIa (rFVIIa) is approved for use in controlling bleeding episodes in people with hemophilia who have developed inhibitors to replacement therapy...
PMC10184128
core_pubmed_pmc
Development of a Potent Nurr1 Agonist Tool for In Vivo Applications
Development of a Potent Nurr1 Agonist Tool for In Vivo Applications Abstract Nuclear receptor related 1 (Nurr1) is a neuroprotective transcription factor and an emerging target in neurodegenerative diseases. Despite strong evidence for a role in Parkinson’s and Alzheimer’s disease, pharmacological control and validatio...
PMC11510379
core_pubmed_pmc
Development of a UHPLC-MS/MS Method for the Determination of Moxidectin in Rat Plasma and Its Application in Pharmacokinetics
Development of a UHPLC-MS/MS Method for the Determination of Moxidectin in Rat Plasma and Its Application in Pharmacokinetics Abstract The aim of the present study was to establish a simple and reliable ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) method and apply it for the deter...
PMC7496395
core_pubmed_pmc
Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon‐γ–Induced Protein 10, BMS‐986184, in Healthy Participants to Guide Therapeutic Dosing
Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon‐γ–Induced Protein 10, BMS‐986184, in Healthy Participants to Guide Therapeutic Dosing Abstract Abstract BMS‐986184 is a human, second‐generation, anti–interferon‐γ–induced protein 10 (IP‐10) monoclon...
PMC5809790
core_pubmed_pmc
Repeated Administration of Opra Kappa (LY2456302), a Novel, Short-Acting, Selective KOP-r Antagonist, in Persons with and without Cocaine Dependence
Repeated Administration of Opra Kappa (LY2456302), a Novel, Short-Acting, Selective KOP-r Antagonist, in Persons with and without Cocaine Dependence Abstract Abstract The κ -opioid receptor (KOP-r) system and its endogenous ligands, the dynorphins, are involved in the neurobiological regulation of addictive states, and...
PMC9298613
core_pubmed_pmc
Effect of sinapic acid on aripiprazole pharmacokinetics in rats: Possible food drug interaction
Effect of sinapic acid on aripiprazole pharmacokinetics in rats: Possible food drug interaction Abstract Dietary supplements and foods can interact with various drugs, leading to possible clinical concerns. This study aimed to investigate the effect of orally administered sinapic acid (SA) on the pharmacokinetics of ar...
PMC8179521
core_pubmed_pmc
Universal endogenous antibody recruiting nanobodies capable of triggering immune effectors for targeted cancer immunotherapy †
Universal endogenous antibody recruiting nanobodies capable of triggering immune effectors for targeted cancer immunotherapy † Abstract Developing monoclonal antibodies (mAbs) for cancer immunotherapy is expensive and complicated. Nanobodies are small antibodies possessing favorable pharmacological properties compared ...
PMC6273104
core_pubmed_pmc
Role of Intestinal Microbiota in Baicalin-Induced Drug Interaction and Its Pharmacokinetics
Role of Intestinal Microbiota in Baicalin-Induced Drug Interaction and Its Pharmacokinetics Abstract Since many glycoside compounds in natural products are hydrolyzed by intestinal microbiota when administered orally, it is of interest to know whether their pharmacological effects are derived from the glycoside itself ...
PMC6558371
core_pubmed_pmc
Preclinical Absorption, Distribution, Metabolism, and Excretion of Sodium Danshensu, One of the Main Water-Soluble Ingredients in Salvia miltiorrhiza , in Rats
Preclinical Absorption, Distribution, Metabolism, and Excretion of Sodium Danshensu, One of the Main Water-Soluble Ingredients in Salvia miltiorrhiza , in Rats Abstract In this study, the absorption, distribution, metabolism and excretion (ADME) of sodium danshensu (Sodium DL-β-(3, 4-dihydroxyphenyl)lactate), one of th...
PMC12087681
core_pubmed_pmc
Optimizing Brentuximab Vedotin Dosing in Pediatric Patients with Advanced Hodgkin Lymphoma: A Population Pharmacokinetic and Exposure‐Response Analysis
Optimizing Brentuximab Vedotin Dosing in Pediatric Patients with Advanced Hodgkin Lymphoma: A Population Pharmacokinetic and Exposure‐Response Analysis Abstract Abstract Pediatric patients with advanced‐stage newly diagnosed Hodgkin lymphoma (HL) were treated with brentuximab vedotin (BV) combined with adriamycin, vinb...
PMC12158829
core_pubmed_pmc
Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development
Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development Abstract Model-informed drug development (MIDD) approaches have become indispensable for new drug development and to address regulatory challenges. Dynamic tools, such as population pharmacokinetics (popPK), physiologically-based pha...
PMC6447844
core_pubmed_pmc
Phase I dose‐escalation study of capmatinib ( INC 280) in Japanese patients with advanced solid tumors
Phase I dose‐escalation study of capmatinib ( INC 280) in Japanese patients with advanced solid tumors Abstract Capmatinib is a highly specific, potent and selective MET inhibitor. This was an open‐label, multicenter, dose‐escalation, phase I study conducted in Japanese patients with advanced solid tumors (not selected...
PMC12130804
core_pubmed_pmc
Longitudinal Genomic Analysis to Fine-tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAF V600 -Mutant Metastatic Melanoma
Longitudinal Genomic Analysis to Fine-tune Targeted Therapy: Results of the Phase II LOGIC 2 Trial in Patients with BRAF V600 -Mutant Metastatic Melanoma Abstract Abstract Purpose: LOGIC 2 ( NCT02159066 ), a multicenter, open-label, two-part, phase II study, assessed encorafenib plus binimetinib combined with a third t...
PMC3281999
core_pubmed_pmc
Alteration in P-glycoprotein Functionality Affects Intrabrain Distribution of Quinidine More Than Brain Entry—A Study in Rats Subjected to Status Epilepticus by Kainate
Alteration in P-glycoprotein Functionality Affects Intrabrain Distribution of Quinidine More Than Brain Entry—A Study in Rats Subjected to Status Epilepticus by Kainate Abstract Abstract This study aimed to investigate the use of quinidine microdialysis to study potential changes in brain P-glycoprotein functionality a...
PMC10224453
core_pubmed_pmc
Systematic Review and Meta-Analysis of the Effect of Loop Diuretics on Antibiotic Pharmacokinetics
Systematic Review and Meta-Analysis of the Effect of Loop Diuretics on Antibiotic Pharmacokinetics Abstract Loop diuretics and antibiotics are commonly co-prescribed across many clinical care settings. Loop diuretics may alter antibiotic pharmacokinetics (PK) via several potential drug interactions. A systematic review...
PMC5658288
core_pubmed_pmc
PharmML in Action: an Interoperable Language for Modeling and Simulation
PharmML in Action: an Interoperable Language for Modeling and Simulation Abstract PharmML 1 is an XML‐based exchange format 2 , 3 , 4 created with a focus on nonlinear mixed‐effect (NLME) models used in pharmacometrics, 5 , 6 but providing a very general framework that also allows describing mathematical and statistica...
PMC9775397
core_pubmed_pmc
Pharmacogenetics and Schizophrenia—Can Genomics Improve the Treatment with Second-Generation Antipsychotics?
Pharmacogenetics and Schizophrenia—Can Genomics Improve the Treatment with Second-Generation Antipsychotics? Abstract Abstract Schizophrenia (SCZ) is a complex psychiatric disorder of multifactorial origin, in which both genetic and environmental factors have an impact on its onset, course, and outcome. Large variabili...
PMC12890486
core_pubmed_pmc
Cannabidiol exerts antiinflammatory effects but maintains T effector memory cell differentiation in humans
Cannabidiol exerts antiinflammatory effects but maintains T effector memory cell differentiation in humans Abstract Abstract BACKGROUND Cannabidiol (CBD) is increasingly used for pain management, including in transplant recipients with limited analgesic options. Its immunomodulatory effects in humans are not well defin...
PMC11215134
core_pubmed_pmc
Comparison of intranasal naloxone and intranasal nalmefene in a translational model assessing the impact of synthetic opioid overdose on respiratory depression and cardiac arrest
Comparison of intranasal naloxone and intranasal nalmefene in a translational model assessing the impact of synthetic opioid overdose on respiratory depression and cardiac arrest Abstract Abstract Introduction Using a validated translational model that quantitatively predicts opioid-induced respiratory depression and c...
PMC3532357
core_pubmed_pmc
Functional Profiling of Live Melanoma Samples Using a Novel Automated Platform
Functional Profiling of Live Melanoma Samples Using a Novel Automated Platform Abstract Aims This proof-of-concept study was designed to determine if functional, pharmacodynamic profiles relevant to targeted therapy could be derived from live human melanoma samples using a novel automated platform. Methods A series of ...
PMC10135351
core_pubmed_pmc
Phytochemicals in Gastrointestinal Nematode Control: Pharmacokinetic–Pharmacodynamic Evaluation of the Ivermectin plus Carvone Combination
Phytochemicals in Gastrointestinal Nematode Control: Pharmacokinetic–Pharmacodynamic Evaluation of the Ivermectin plus Carvone Combination Abstract Abstract Simple Summary In the last 50 years, limited modern drugs with new mechanisms of action have been incorporated; consequently, drug resistance has increased worldwi...
PMC12755099
core_pubmed_pmc
Xenin-Derived Peptides: Multifaceted Regulators and Therapeutic Innovations in Metabolic Diseases
Xenin-Derived Peptides: Multifaceted Regulators and Therapeutic Innovations in Metabolic Diseases Abstract Abstract Xenin, a 25-amino acid peptide hormone predominantly secreted by intestinal K cells, demonstrates evolutionary conservation with neuropeptides such as xenopsin and neurotensin. Functionally, it engages ne...
PMC9349773
core_pubmed_pmc
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID ‐19, in Subjects With Renal Impairment
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID ‐19, in Subjects With Renal Impairment Abstract Nirmatrelvir coadministered with ritonavir is highly efficacious in reducing the risk of coronavirus disease 2019 (COVID‐19) adverse outcomes among patients at increased risk of p...
PMC9652116
core_pubmed_pmc
The Limitations and Unmet Needs of the Five Cornerstones to Guarantee Lifelong Optimization of Prophylaxis in Hemophilia Patients
The Limitations and Unmet Needs of the Five Cornerstones to Guarantee Lifelong Optimization of Prophylaxis in Hemophilia Patients Abstract Prophylaxis to prevent bleeding is highly recommended for hemophilia patients. The development of new drugs and tools for modeling personalized prophylaxis provides the means for pe...
PMC12410301
core_pubmed_pmc
[ 64 Cu]Cu-NOTA-EV-F(ab′) 2 Enables Same-Day Immuno-PET Imaging of Nectin-4 in Triple-Negative Breast and Urothelial Bladder Cancers
[ 64 Cu]Cu-NOTA-EV-F(ab′) 2 Enables Same-Day Immuno-PET Imaging of Nectin-4 in Triple-Negative Breast and Urothelial Bladder Cancers Abstract Our study aimed to develop and evaluate [ 64 Cu]Cu-NOTA-EV-F(ab′) 2 for immuno-PET imaging of nectin-4 expression in triple-negative breast cancer (TNBC) and urothelial bladder c...