A5101987538- Biosimilars and Bioanalytical Methods
- Pharmaceutical studies and practices
- Diabetes Treatment and Management
- Monoclonal and Polyclonal Antibodies Research
- Chronic Lymphocytic Leukemia Research
- Long-Term Effects of COVID-19
- Respiratory viral infections research
- Pancreatic function and diabetes
- Rheumatoid Arthritis Research and Therapies
- Liver Disease and Transplantation
- Pharmaceutical Economics and Policy
- Liver Disease Diagnosis and Treatment
- Receptor Mechanisms and Signaling
- COVID-19 Clinical Research Studies
- SARS-CoV-2 and COVID-19 Research
- Statistical Methods in Clinical Trials
- Influenza Virus Research Studies
- Antiplatelet Therapy and Cardiovascular Diseases
- Galectins and Cancer Biology
- Hormonal Regulation and Hypertension
- Drug-Induced Hepatotoxicity and Protection
- Peroxisome Proliferator-Activated Receptors
- Peptidase Inhibition and Analysis
- Pharmacological Effects and Toxicity Studies
- Blood Pressure and Hypertension Studies
First Hospital of Jilin University
2017-2024
Jilin University
2015-2024
Guangdong Academy of Medical Sciences
2024
Southern Medical University
2024
Nanjing Medical University
2018-2024
Sichuan University
2021-2022
West China Hospital of Sichuan University
2022
State Key Laboratory of Oral Diseases
2021
Cedars-Sinai Medical Center
2021
Liaocheng People's Hospital
2020
Data are limited on the impact of neuraminidase inhibitor (NAI) treatment avian influenza A(H7N9) virus RNA shedding.In this multicenter, retrospective study, data were collected from adults hospitalized with infection during 2013-2017 in China. We compared clinical features and shedding among patients different NAI doses combination therapies evaluated factors associated shedding, using Cox proportional hazards regression.Among 478 patients, median age was 56 years, 71% male, 37% died. The...
<bold>Objective:</bold> This study aimed to identify additional characteristics and features of coronavirus disease (COVID-19) by assessing the clinical courses among COVID-19 patients in a region outside Hubei province. <bold>Methods:</bold> We analyzed retrospective data regarding general characteristics, epidemiologic history, underlying chronic diseases, symptoms complications, chest computed tomography findings, biochemical monitoring, severity, treatments, outcomes 37 adult with...
BACKGROUND: Although the information on validation status of electronic sphygmomanometer (ES) devices in use health care institutions and households is much more clinically relevant than that ES models available market, it remains insufficient. METHODS: A national survey was conducted across all administrative regions mainland China to assess ESs. Fifty-eight cities were selected with stratification by municipality, provincial capital, other cities, each city chosen convenience identify...
Objective: The aim of the study was to explore association pharmacokinetic variability and pharmacogenomics with bioequivalence orally administered gefitinib (Iressa®, AstraZeneca) provided by three sponsors in healthy subjects. Methods: designs were randomized, open-label, two-period crossover studies both fasting fed In one study, sample size enlarged from 30 60 for failing study. Each subject received a 250-mg tablet 21-day washout. plasma concentrations measured using LC-MS/MS,...
This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.This is a randomized, double-blind, two-arm, parallel performed examine bioequivalence biosimilar, QL1206, with that Xgeva® (Denosumab) as reference drug. A single dose 120 mg/kg or administered subjects, who were followed up for 134 days.Similar PK properties those exhibited by QL1206. When compared QL1206 Xgeva®, 90%...
ABSTRACT We have constructed a series of vectors based on simian foamy virus type 1 (SFV-1) to define the minimum cis -acting elements required for gene transfer. To characterize these vectors, we inserted coding sequence bacterial lacZ linked cytomegalovirus immediate-early promoter. Introduction deletion mutation in leader region between 5′ long terminal repeat and start gag at position 1659 1694 completely abrogated transfer by SFV-1 vector. Deletion 39 nucleotides from 1692 1731 resulted...
Iron deficiency (ID) is one of the most commonly known nutritional deficiencies and considered primary cause anemia (iron-deficiency anemia). Ferric carboxymaltose (FCM), an intravenous iron preparation, has been widely used for >10 years iron-deficiency treatment worldwide because its many advantages.This single-center, open-label, single dose escalation study in Chinese subjects was designed to assess pharmacokinetic/pharmacodynamic parameters safety FCM this population. The first 12...
Abstract The effect of age on the pharmacokinetics and safety chiglitazar was evaluated in patients < 65 ≥ years with type 2 diabetes mellitus (T2DM). A total 20 T2DM (<65 vs ≥65 1:1) completed study. Patients received multiple doses 48 mg once daily for 7 days consecutively. After first dosing, maximum plasma concentration (C max ) area under concentration‐time curve (AUC) were similar to those observed years, geometric mean ratio (GMR) C AUC being 97.22% 96.83%, respectively. No...
Objective: The study aimed to explore the bioequivalence of a proposed biosimilar BAT1806 its reference products marketed in EU and US (RoActemra-EU Actemra-US) among healthy Chinese men. tolerance, immunogenicity, pharmacokinetics (PK) three drugs were also investigated. Methods: In this randomized, double-blind, single-dose, three-arm, parallel study, single-dose 4 mg/kg products, or was administered participants. participants followed up for 57 days, PK, tolerance evaluations completed...
Few studies on the humoral immune responses in human during natural influenza infection have been reported. Here, we used serum samples from pandemic 2009 H1N1 infected patients to characterize humans. We observed for first time that induced A-specific IgM within days after symptoms onset, whereas unit of IgG did not changed. The magnitude antibodies might a value predicting rate virus clearance some degree. However, newly developed was associated with hemagglutination inhibition (HI)...
KN012 is a proposed biosimilar candidate for the reference drug denosumab, with brand name Prolia®. This study explored tolerance, variability, and pharmacokinetics (PK) of denosumab its in healthy Chinese subjects.A randomized, double-blind, parallel, two-arm was performed to analyze bioequivalence (60 mg) compared denosumab.The PK properties were similar those denosumab. When geometric mean ratios (GMRs) Cmax, AUC0-t, AUC0-∞ 98.74%, 102.54%, 102.18%, respectively, 90% confidence interval...
Objective This observational cross-sectional study evaluated the distribution of ultrasound (US) features lower-limb joints and risk factors tophus in gout patients. Methods We examined 588 including bilateral knee, ankle, first metatarsophalangeal (MTP) 98 patients by US between March to August 2017. The double-contour (DC), tophus, aggregates, synovitis, effusion erosion different joint, course, age groups were investigated Cochran Q χ 2 test. analyzed using logistic regression method....
To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of proposed biosimilar IBI305 with those bevacizumab in healthy male subjects.A phase I, randomized, double-blinded, two-arm, parallel-group study.The study was conducted The First Hospital Jilin University, Changchun, China, from March 2017 to November 2017.A total 100 subjects were enrolled, 48 group 50 included final analysis.In a 16-week course, participants randomized at 1:1 ratio receive intravenous administration...
Influenza is an acute respiratory illness. Treating with antiviral drugs can decrease the duration of illness and serious complications . ZSP1273 a small-molecule anti-influenza drug targeting RNA polymerase PB2 subunit influenza virus. The aim this clinical trial was to evaluate safety pharmacokinetics (PKs) in healthy subjects.This double-blind, placebo-controlled phase 1 study consisting three parts. 100 volunteers were enrolled randomized receive either single or multiple doses placebo.A...
Background Forsythin, an active compound from Forsythiae Fructus, has the potential to treat common cold and influenza through its antipyretic-analgesic, anti-inflammatory antiviral effects. The safety, tolerability pharmacokinetic (PK) profile of forsythin were evaluated in healthy Chinese subjects.
The present study was designed to assess the bioequivalence of two agomelatine formulations (25-mg tablets) in healthy Chinese male subjects. This single-dose, open-label, randomized, four-way replicate with a 1-week washout period conducted 60 volunteers under fasting conditions. Blood samples were collected over 12-h after single dose 25-mg test (T) formulation or reference (R) formulation, and drug concentrations assayed by liquid chromatography tandem mass spectrometry (LC-MS/MS)....
Objectives: The study aimed to explore the bioequivalence of a proposed biosimilar HL02 vs. its reference products (US-trastuzumab) among healthy Chinese men.Methods: In this study, nine male subjects received single ascending doses trastuzumab (HL02, 2–8 mg/kg), and then randomized, double-blind, two-arm, parallel was conducted investigate PK similarity (6 mg/kg) with that US-trastuzumab as drug.Results: properties exhibited by (N = 55) were similar those 52). comparison biosimilarity...
Abstract Objective To find out more characteristics and rules of COVID-19 by analyzing the clinical course patients in a region outside Hubei province. Methods 37 cases diagnosed adult general characteristics, history epidemiology, chronic underlying diseases, symptoms complications, chest CT, biochemical monitoring, severity assessment, treatment outcome were retrospectively analyzed, according to duration from onset release quarantine divided into ≤20 -day group > 20 group, compare...
Objective To evaluate the effect of food on pharmacokinetics (PK) fluzoparib capsule.Methods PK data were obtained after treatment in a crossover design study. Single-dose (120 mg) was administered under fasted and fed conditions to 16 healthy subjects. Metabolism transformation analyzed by liquid chromatograph-tandem mass spectrometry first period. Safety also assessed.Results The absorption rate slower group (tmax delayed 3 h), peak exposure (Cmax) plasma decreased 19.8% (p < 0.05)...
Purpose QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated tolerance, variability, and pharmacokinetics (PK) of in healthy Chinese male subjects.Design A randomised, double-blind, two-arm, parallel study was performed to examine bioequivalence (8 mg/kg) with that Actemra® as drug.Results (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% 18.78%. 90% confidence intervals ratios Cmax, AUC0–t andAUC0–∞ both...