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Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm
Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm
As drug development scientists strive to accelerate availability of therapies for patients, model-informed drug developmen...
A Population Pharmacokinetic Analysis of l-Glutamine Exposure in Patients with Sickle Cell Disease: Evaluation of Dose and Food Effects
A Population Pharmacokinetic Analysis of l-Glutamine Exposure in Patients with Sickle Cell Disease: Evaluation of Dose and Food Effects
l-Glutamine is a treatment for children and adults with sickle cell disease. A comprehensive evaluation of the pharmacokin...
Toward Genetic Testing of Rivaroxaban? Insights from a Systematic Review on the Role of Genetic Polymorphism in Rivaroxaban Therapy
Toward Genetic Testing of Rivaroxaban? Insights from a Systematic Review on the Role of Genetic Polymorphism in Rivaroxaban Therapy
Investigations into the rivaroxaban response from the perspective of genetic variation have been relatively recent and wid...
Bayesian Vancomycin Model Selection for Therapeutic Drug Monitoring in Neonates
Bayesian Vancomycin Model Selection for Therapeutic Drug Monitoring in Neonates
Pharmacokinetic models can inform drug dosing of vancomycin in neonates to optimize therapy. However, the model selected n...
Population Pharmacokinetic/Pharmacodynamic Models for P2Y12 Inhibitors: A Systematic Review and Clinical Appraisal Using Exposure Simulation
Population Pharmacokinetic/Pharmacodynamic Models for P2Y12 Inhibitors: A Systematic Review and Clinical Appraisal Using Exposure Simulation
Recent research indicates a correlation between plasma concentration of P2Y12 inhibitors and clinical events, particularly...
Lumacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients with Cystic Fibrosis: A First Step Toward Personalized Therapy
Lumacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients with Cystic Fibrosis: A First Step Toward Personalized Therapy
A major breakthrough in cystic fibrosis (CF) therapy was achievedAQ1 with CFTR modulators. The lumacaftor/ivacaftor combin...
Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
P2X3 receptor antagonists hold promising potential as a therapeutic option for patients with refractory or unexplained chr...
Towards More Robust Evaluation of the Predictive Performance of Physiologically Based Pharmacokinetic Models: Using Confidence Intervals to Support Use of Model-Informed Dosing in Clinical Care
Towards More Robust Evaluation of the Predictive Performance of Physiologically Based Pharmacokinetic Models: Using Confidence Intervals to Support Use of Model-Informed Dosing in Clinical Care
With the rise in the use of physiologically based pharmacokinetic (PBPK) modeling over the past decade, the use of PBPK mo...
Maternal Ezetimibe Concentrations Measured in Breast Milk and Its Use in Breastfeeding Infant Exposure Predictions
Maternal Ezetimibe Concentrations Measured in Breast Milk and Its Use in Breastfeeding Infant Exposure Predictions
Lactating mothers taking ezetimibe, an antihyperlipidemic agent, may be hesitant to breastfeed despite the known benefit o...
Clinical Pharmacokinetics and Pharmacodynamics of Naloxone
Clinical Pharmacokinetics and Pharmacodynamics of Naloxone
Naloxone is a World Health Organization (WHO)-listed essential medicine and is the first choice for treating the respirato...
Performance of Eight Infliximab Population Pharmacokinetic Models in a Cohort of Dutch Children with Inflammatory Bowel Disease
Performance of Eight Infliximab Population Pharmacokinetic Models in a Cohort of Dutch Children with Inflammatory Bowel Disease
Efficacy of infliximab in children with inflammatory bowel disease can be enhanced when serum concentrations are measured ...
Optimization of Ganciclovir and Valganciclovir Starting Dose in Children by Machine Learning
Optimization of Ganciclovir and Valganciclovir Starting Dose in Children by Machine Learning
Ganciclovir (GCV) and valganciclovir (VGCV) show large interindividual pharmacokinetic variability, particularly in childr...
Population Pharmacodynamic Dose–Response Analysis of Serum Potassium Following Dosing with Sodium Zirconium Cyclosilicate
Population Pharmacodynamic Dose–Response Analysis of Serum Potassium Following Dosing with Sodium Zirconium Cyclosilicate
Sodium zirconium cyclosilicate (SZC) is an approved oral treatment for hyperkalemia that selectively binds potass...
Predictions of Bedaquiline Central Nervous System Exposure in Patients with Tuberculosis Meningitis Using Physiologically based Pharmacokinetic Modeling
Predictions of Bedaquiline Central Nervous System Exposure in Patients with Tuberculosis Meningitis Using Physiologically based Pharmacokinetic Modeling
The use of bedaquiline as a treatment option for drug-resistant tuberculosis meningitis (TBM) is of interest to address th...
Personalized Antifungal Therapy Through Model-Informed Precision Dosing of Posaconazole
Personalized Antifungal Therapy Through Model-Informed Precision Dosing of Posaconazole
Posaconazole is a pharmacotherapeutic pillar for prophylaxis and treatment of invasive fungal diseases. Dose individualiza...
Have We Neglected to Study Target-Site Drug Exposure in Children? A Systematic Review of the Literature
Have We Neglected to Study Target-Site Drug Exposure in Children? A Systematic Review of the Literature
Drug dosing should ideally be based on the drug concentrations at the target site, which, for most drugs, corresponds to t...
Population Pharmacokinetic/Pharmacodynamic Analysis of the Glucokinase Activator PB201 in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus: Facilitating the Clinical Development of PB201 in China
Population Pharmacokinetic/Pharmacodynamic Analysis of the Glucokinase Activator PB201 in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus: Facilitating the Clinical Development of PB201 in China
PB201 is an orally active, partial glucokinase activator targeting both pancreatic and hepatic glucokinase. As the second ...
Digoxin Pharmacokinetics in Patients with Obesity Before and After a Gastric Bypass or a Strict Diet Compared with Normal Weight Individuals
Digoxin Pharmacokinetics in Patients with Obesity Before and After a Gastric Bypass or a Strict Diet Compared with Normal Weight Individuals
Several drugs on the market are substrates for P-glycoprotein (P-gp), an efflux transporter highly expressed in barrier ti...
Impact of Key Components of Intensified Ceftaroline Dosing on Pharmacokinetic/Pharmacodynamic Target Attainment
Impact of Key Components of Intensified Ceftaroline Dosing on Pharmacokinetic/Pharmacodynamic Target Attainment
Ceftaroline fosamil is a β-lactam antibiotic approved as a 600 mg twice daily dose (≤1 h infusion, ...
Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime
Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime
Physiologically based pharmacokinetic (PBPK) models for pregnant women have recently been successfully used to predict mat...
How to Dose Vancomycin in Overweight and Obese Patients with Varying Renal (Dys)function in the Novel Era of AUC 400–600 mg·h/L-Targeted Dosing
How to Dose Vancomycin in Overweight and Obese Patients with Varying Renal (Dys)function in the Novel Era of AUC 400–600 mg·h/L-Targeted Dosing
The latest vancomycin guideline recommends area under the curve (AUC)-targeted dosing and monitoring for efficacy and safe...
Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review
Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antifungal Agents: A Review
Antifungal drug development is essential as invasive fungal disease is still associated with a very high mortality rate an...
Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers
Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers
Sotrovimab 500 mg administered by a single intravenous (IV) infusion has been granted special approval for emergency use i...
Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development
Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development
Ritlecitinib is an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor undergoing p...
Interplay of UDP-Glucuronosyltransferase and CYP2C8 for CYP2C8 Mediated Drug Oxidation and Its Impact on Drug–Drug Interaction Produced by Standardized CYP2C8 Inhibitors, Clopidogrel and Gemfibrozil
Interplay of UDP-Glucuronosyltransferase and CYP2C8 for CYP2C8 Mediated Drug Oxidation and Its Impact on Drug–Drug Interaction Produced by Standardized CYP2C8 Inhibitors, Clopidogrel and Gemfibrozil
Early investigations into drug–drug interactions (DDIs) involving cytochrome P450 2C8 (CYP2C8) have highlighted the ...
A Phase I, Open-Label, Fixed Sequence Study to Investigate the Effect of Cytochrome P450 2D6 Inhibition on the Pharmacokinetics of Ulotaront in Healthy Subjects
A Phase I, Open-Label, Fixed Sequence Study to Investigate the Effect of Cytochrome P450 2D6 Inhibition on the Pharmacokinetics of Ulotaront in Healthy Subjects
Ulotaront is a novel psychotropic agent with agonist activity at trace amine-associated receptor 1 (TAAR1) and 5-hydroxytr...
The Pharmacokinetics of the Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone
The Pharmacokinetics of the Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone
Finerenone, a selective and nonsteroidal antagonist of the mineralocorticoid receptor, has received regulatory approval wi...
Prognostic Value of Nivolumab Clearance in Non-Small Cell Lung Cancer Patients for Survival Early in Treatment
Prognostic Value of Nivolumab Clearance in Non-Small Cell Lung Cancer Patients for Survival Early in Treatment
Immune checkpoint inhibitors improved survival of advanced stage non-small cell lung cancer patients, but the overall resp...
Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Oral gonadotropin-releasing hormone (GnRH) antagonists are promising agents in the treatment of endometriosis-related pain...
Plasma Pharmacokinetics of N-Acetylgalactosamine-Conjugated Small-Interfering Ribonucleic Acids (GalNAc-Conjugated siRNAs)
Plasma Pharmacokinetics of N-Acetylgalactosamine-Conjugated Small-Interfering Ribonucleic Acids (GalNAc-Conjugated siRNAs)
Small-interfering ribonucleic acids (siRNAs) with N-acetylgalactosamine (GalNAc) conjugation for improved liver uptake rep...
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