Guo‐Xiang Hao
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View article: Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain
Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain Open
Ibuprofen is a commonly used nonsteroidal anti‐inflammatory drug, and its injectable form has specific clinical applications. However, ibuprofen injection has not been approved for use in Chinese children. This study aimed to support its a…
View article: Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir
Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir Open
During a Public Health Emergency of International Concern (PHEIC), rapid drug development is critical, but traditional clinical trials are time-consuming and high-risk. This study used coronavirus disease 2019 (COVID-19) as an example to h…
View article: Machine learning approach for dosage individualization of azithromycin in children with community‐acquired pneumonia
Machine learning approach for dosage individualization of azithromycin in children with community‐acquired pneumonia Open
Aims The uncertainty about the efficacy and safety of currently used azithromycin dosing regimens in children warrants individualized therapy. The area under the plasma concentration‐time curve over 24 h (AUC 0‐24 ) of azithromycin correla…
View article: 21 A first-in-human phase 1 study of SIM0417, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects
21 A first-in-human phase 1 study of SIM0417, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects Open
Introduction Safe and efficacious antiviral therapeutics are in urgent need for treatment of coronavirus disease 2019. SIM0417 is a selective 3C-like protease inhibitor that can effectively inhibit severe acute respiratory syndrome coronav…
View article: 18 Use of machine learning for dosage individualization of vancomycin in neonates
18 Use of machine learning for dosage individualization of vancomycin in neonates Open
Introduction High variability in vancomycin exposure in neonates requires advanced individualized dosing regimens. Achieving steady-state trough concentration (C0) and steady-state area-under-curve (AUC0-24) targets are important to optimi…
View article: Optimal use of β-lactams in neonates: machine learning-based clinical decision support system
Optimal use of β-lactams in neonates: machine learning-based clinical decision support system Open
View article: Accuracy of antibiotic concentrations in drug dispensing in neonates: a laboratory-based study
Accuracy of antibiotic concentrations in drug dispensing in neonates: a laboratory-based study Open
Background Antibacterial therapy plays a crucial role in neonatal infections. The efficacy of antibacterial agents is closely related to the actual dose given to neonates. So we evaluated factors potentially affecting the actual dose of in…
View article: A first-in-human phase 1 study of simnotrelvir, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects
A first-in-human phase 1 study of simnotrelvir, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects Open
Safe and efficacious antiviral therapeutics are in urgent need for the treatment of coronavirus disease 2019. Simnotrelvir is a selective 3C-like protease inhibitor that can effectively inhibit severe acute respiratory syndrome coronavirus…
View article: Optimizing ganciclovir and valganciclovir dosing regimens in pediatric patients with cytomegalovirus infection: a spotlight on therapeutic drug monitoring
Optimizing ganciclovir and valganciclovir dosing regimens in pediatric patients with cytomegalovirus infection: a spotlight on therapeutic drug monitoring Open
GCV/VGCV TDM has shown the potential value to improve the benefit/risk ratio in pediatrics when using the therapeutic ranges derived from adults. However, well-designed studies are required to evaluate the relationship of TDM with clinical…
View article: Developmental Population Pharmacokinetics-Pharmacodynamics of Meropenem in Chinese Neonates and Young Infants: Dosing Recommendations for Late-Onset Sepsis
Developmental Population Pharmacokinetics-Pharmacodynamics of Meropenem in Chinese Neonates and Young Infants: Dosing Recommendations for Late-Onset Sepsis Open
The pharmacokinetic (PK) studies of meropenem in Chinese newborns with late-onset sepsis (LOS) are still lacking. Causative pathogens of LOS and their susceptibility patterns in China differ from the data abroad. We, therefore, conducted a…
View article: Optimal dose of meropenem for the treatment of neonatal sepsis: Dosing guideline variations and clinical practice deviations
Optimal dose of meropenem for the treatment of neonatal sepsis: Dosing guideline variations and clinical practice deviations Open
Aims Meropenem is increasingly used to treat neonatal sepsis. There are several guidelines recommending different dosing regimens of meropenem in neonates. Furthermore, deviations from these guidelines regularly occur in daily clinical pra…
View article: Clinical utiliy of a model‐based piperacillin dose in neonates with early‐onset sepsis
Clinical utiliy of a model‐based piperacillin dose in neonates with early‐onset sepsis Open
Aims Early‐onset sepsis (EOS) is a common disease in neonates with a high morbidity and mortality rate. Piperacillin/tazobactam has been used extensively and empirically for EOS treatment without clinically validated dosing regimens, altho…
View article: LPS-Induced Inflammation Affects Midazolam Clearance in Juvenile Mice in an Age-Dependent Manner
LPS-Induced Inflammation Affects Midazolam Clearance in Juvenile Mice in an Age-Dependent Manner Open
PURPOSE: Inflammation has a significant impact on CYP3A activity. We hypothesized that this effect might be age dependent. Our objective was to conduct a population pharmacokinetic study of midazolam in mice at different developmental stag…
View article: Developmental Pharmacogenetics of CYP2D6 in Chinese Children: Loratadine as a Substrate Drug
Developmental Pharmacogenetics of CYP2D6 in Chinese Children: Loratadine as a Substrate Drug Open
Objective: The elucidation of CYP2D6 developmental pharmacogenetics in children has improved, however, these findings have been largely limited to studies of Caucasian children. Given the clear differences in CYP2D6 pharmacogenetic profile…
View article: CYP3A5 Genotype-Dependent Drug-Drug Interaction Between Tacrolimus and Nifedipine in Chinese Renal Transplant Patients
CYP3A5 Genotype-Dependent Drug-Drug Interaction Between Tacrolimus and Nifedipine in Chinese Renal Transplant Patients Open
Purpose: The drug-drug interactions (DDIs) of tacrolimus greatly contributed to pharmacokinetic variability. Nifedipine, frequently prescribed for hypertension, is a competitive CYP3A5 inhibitor which can inhibit tacrolimus metabolism. The…
View article: Drug Clearance in Neonates: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction
Drug Clearance in Neonates: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction Open
View article: Downregulation of Renal MRPs Transporters in Acute Lymphoblastic Leukemia Mediated by the IL-6/STAT3/PXR Signaling Pathway
Downregulation of Renal MRPs Transporters in Acute Lymphoblastic Leukemia Mediated by the IL-6/STAT3/PXR Signaling Pathway Open
Inflammation-mediated changes in pharmacokinetics are thought to be executed through pathways IL-6-activated pathways, which can facilitate a better understanding of the potential for the use of IL-6 to predict the severity of adverse outc…
View article: Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance
Population Pharmacokinetic Study of Cefathiamidine in Infants With Augmented Renal Clearance Open
Objectives: Augmented renal clearance (ARC) of primarily renally eliminated antibacterial agents may result in subtherapeutic antibiotic concentrations and, as a consequence, worse clinical outcomes. Cefathiamidine is frequently used as em…
View article: Population pharmacokinetics and dosing optimization of metformin in Chinese patients with type 2 diabetes mellitus
Population pharmacokinetics and dosing optimization of metformin in Chinese patients with type 2 diabetes mellitus Open
Approximately 35% of patients fail to attain ideal initial blood glucose control under metformin monotherapy. The objective of this observational study is to simulate the optimal protocol of metformin according to the different renal funct…
View article: Prolylcarboxypeptidase Mitigates Myocardial Ischemia/Reperfusion Injury by Stabilizing Mitophagy
Prolylcarboxypeptidase Mitigates Myocardial Ischemia/Reperfusion Injury by Stabilizing Mitophagy Open
The role of prolylcarboxypeptidase (PRCP) in myocardial ischemia/reperfusion (I/R) injury is unclear. Herein, we aimed to evaluate the protective effect of the PRCP-angiotensin-(1-7) [Ang-(1-7)]/bradykinin-(1-9) [BK-(1-9)] axis on myocardi…
View article: Prediction of Unbound Ceftriaxone Concentration in Children: Simple Bioanalysis Method and Basic Mathematical Equation
Prediction of Unbound Ceftriaxone Concentration in Children: Simple Bioanalysis Method and Basic Mathematical Equation Open
The pharmacological activity of ceftriaxone depends on the unbound concentration. However, direct measurement of unbound concentrations is obstructive, and high individual variability of the unbound fraction of ceftriaxone was shown in chi…
View article: Optimal Dosing of Ceftriaxone in Infants Based on a Developmental Population Pharmacokinetic-Pharmacodynamic Analysis
Optimal Dosing of Ceftriaxone in Infants Based on a Developmental Population Pharmacokinetic-Pharmacodynamic Analysis Open
Ceftriaxone is a third-generation cephalosporin used to treat infants with community-acquired pneumonia. Currently, there is a large variability in the amount of ceftriaxone used for this purpose in this particular age group, and an eviden…
View article: Personalized application of three different concentrations of iodinated contrast media in coronary computed tomography angiography
Personalized application of three different concentrations of iodinated contrast media in coronary computed tomography angiography Open
No study has evaluated the impact of different iodinated contrast media on coronary contrast enhancement, using an injection protocol according to body surface area (BSA). Thus, the present study aimed to examine the usefulness and safety …
View article: Paediatric drugs trials in China
Paediatric drugs trials in China Open
Objective Clinical trials of children’s drugs are of great significance to rational drug use in children. However, paediatric drugs trials in China are facing complex challenges. At present, the investigation data on registration status of…
View article: Precision therapy of 6‐mercaptopurine in Chinese children with acute lymphoblastic leukaemia
Precision therapy of 6‐mercaptopurine in Chinese children with acute lymphoblastic leukaemia Open
Aims Chinese children are more susceptible to the development of thiopurine‐induced leukopenia compared with Caucasian populations. The aim of our study was to establish a 6‐mercaptopurine (6‐MP) dose–concentration–response relationship th…
View article: Developmental Population Pharmacokinetics and Dosing Optimization of Cefepime in Neonates and Young Infants
Developmental Population Pharmacokinetics and Dosing Optimization of Cefepime in Neonates and Young Infants Open
A population pharmacokinetic model of cefepime in neonates and young infants was established. According to simulation results based on the developmental pharmacokinetics-pharmacodynamics, different dosage regimens should be given depending…
View article: <p>Developmental Pharmacogenetics of SLCO2B1 on Montelukast Pharmacokinetics in Chinese Children</p>
Developmental Pharmacogenetics of SLCO2B1 on Montelukast Pharmacokinetics in Chinese Children Open
The developmental pharmacology of montelukast in Chinese children was evaluated. Weight and SLCO2B1 genotype were found to have independent significant impacts on the clearance of montelukast.
View article: Off‐label use of tacrolimus in children with glomerular disease: Effectiveness, safety and pharmacokinetics
Off‐label use of tacrolimus in children with glomerular disease: Effectiveness, safety and pharmacokinetics Open
Glomerular diseases are leading causes of end‐stage renal disease in children. Tacrolimus is frequently used off‐label in the treatment of glomerular diseases. The effectiveness, safety and pharmacokinetic data of tacrolimus in the treatme…
View article: Population pharmacokinetics of tacrolimus in children with nephrotic syndrome
Population pharmacokinetics of tacrolimus in children with nephrotic syndrome Open
Aims Nephrotic syndrome (NS) is the most common clinical manifestation of glomerular disease in children. Currently, tacrolimus (TAC) is widely used in children with NS. However, pharmacokinetic data in children with nephrotic syndrome is …
View article: Research on the Reform of Material Forming and Controlling Engineering Major on the Basis of CDIO
Research on the Reform of Material Forming and Controlling Engineering Major on the Basis of CDIO Open
The idea and scheme of project teaching reform was put forward based on CDIO to change the low practical abilities of material forming and controlling engineering undergraduates. On the basis of the teaching characteristics of material for…