A5100641685- Statistical Methods in Clinical Trials
- Pharmaceutical studies and practices
- Pharmacogenetics and Drug Metabolism
- Health Systems, Economic Evaluations, Quality of Life
- Biosimilars and Bioanalytical Methods
- Computational Drug Discovery Methods
- Antibiotics Pharmacokinetics and Efficacy
- Pharmaceutical Economics and Policy
- Cardiac electrophysiology and arrhythmias
- Rheumatoid Arthritis Research and Therapies
- Receptor Mechanisms and Signaling
- Monoclonal and Polyclonal Antibodies Research
- Alzheimer's disease research and treatments
- Neutropenia and Cancer Infections
- Analytical Methods in Pharmaceuticals
- Asthma and respiratory diseases
- COVID-19 Clinical Research Studies
- Pesticide Residue Analysis and Safety
- Cancer Immunotherapy and Biomarkers
- Treatment of Major Depression
- Anesthesia and Sedative Agents
- Inhalation and Respiratory Drug Delivery
- Drug Solubulity and Delivery Systems
- Biomedical Ethics and Regulation
- Medication Adherence and Compliance
Hebei Medical University
2020-2025
Yangzhou University
2025
Xingtai People's Hospital
2025
Binzhou Medical University
2018-2024
Binzhou University
2018-2024
Institute of Urban Environment
2024
University of Chinese Academy of Sciences
2024
Center for Drug Evaluation and Research
2013-2024
Johns Hopkins University
2024
Soochow University
2023-2024
Model‐informed drug development (MIDD) refers to the application of a wide range quantitative models in facilitate decision‐making process. MIDD was formally recognized Prescription Drug User Fee Act (PDUFA) VI. There have been many regulatory applications address variety and questions. These can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, informing policy. Case studies, literature papers, published documents are...
Abstract Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to US Food and Drug Administration (FDA). In 2018, Administration's Office Clinical Pharmacology published a commentary summarizing application PBPK modeling submissions it received between 2008 2017 its impact on prescribing information. this commentary, we provide an update 2018 2019 highlight few notable...
Engineered cardiac tissues (ECTs) derived from human induced pluripotent stem cells (hiPSCs) are viable alternatives for repair, patient-specific disease modeling, and drug discovery. However, the immature state of ECTs limits their clinical utility. The microenvironment fabricated using 3D scaffolds can affect cell fate, is crucial maturation ECTs. Herein, authors demonstrate an electric-field-driven (EFD) printed highly ordered microstructure with feature size to promote simulation...
Abstract: Large numbers of neuritic plaques surrounded by reactive astrocytes are characteristic Alzheimer's disease (AD). There is a large body research supporting causal role for the amyloid β peptide (Aβ), main constituent these plaques, in neuropathology AD. Several hypotheses have been proposed to explain toxicity Aβ including free radical injury and excitotoxicity. It has reported that treatment neuronal/astrocytic cultures with increases vulnerability neurons glutamate‐induced cell...
Exploration of FVC as it relates to mortality in idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and ultimately fatal parenchymal lung disease, is important both clinically the current drug development paradigm. We evaluated association between decline what our knowledge largest well-characterized placebo cohort date. Additionally, we sought explore risk death caused by acute exacerbations further validate previously identified baseline predictors mortality.To characterize...
The use of computational models in drug development has grown during the past decade. These model‐informed (MIDD) approaches can inform a variety and regulatory decisions. When used for decision making, it is important to establish that model credible its intended use. Currently, there no consensus on how assess credibility, including selection appropriate verification validation activities. In this article, we apply risk‐informed credibility assessment framework physiologically‐based...
Translation of in vitro antiviral activity to the vivo setting is crucial identify potentially effective dosing regimens hydroxychloroquine. In 50%/90% maximal concentration values for hydroxychloroquine should be compared free extracellular tissue concentration, which similar plasma concentration.
During spaceflight, the cardiovascular system undergoes remarkable adaptation to microgravity and faces risk of cardiac remodeling. Therefore, effects mechanisms on morphology, physiology, metabolism, cellular biology need be further investigated. Since China started constructing Space Station (CSS) in 2021, we have taken advantage Shenzhou-13 capsule send human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) Tianhe core module CSS. In this study, hPSC-CMs subjected space showed...
Abstract Modeling the relationships between covariates and pharmacometric model parameters is a central feature of analyses. The information obtained from covariate modeling may be used for dose selection, individualization, or planning clinical studies in different population subgroups. literature has amassed diverse, complex, evolving collection methodologies interpretive guidance related to modeling. With number complexity technologies increasing, need an overview state art emerged. In...
To reduce the bias introduced by confounding risk factors, a case-control comparison was incorporated in exposure-response (ER) analysis to evaluate recommended dosing regimen for trastuzumab pivotal trial. Results of Kaplan-Meier survival suggest that patients with metastatic gastric cancer (mGC) lowest quartile trough concentrations cycle 1 (C(min 1) ) had shorter overall (OS) than did those other quartiles. The result case-matched control suggests adjusting these exposure not benefit from...
On December 18, 2015, the FDA granted regular approval to pembrolizumab (KEYTRUDA; Merck Sharp & Dohme Corp.) for treatment of patients with unresectable or metastatic melanoma based on results two randomized, open-label, active-controlled clinical trials. In trial PN006, 834 ipilimumab-naïve were randomized (1:1:1) 10 mg/kg i.v. every 2 3 weeks until disease progression ipilimumab up four doses. PN002, 540 ipilimumab-refractory investigator's choice chemotherapy. demonstrated a...
Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there notable increase in number of regulatory submissions contain QSP, including Investigational New Drug Applications (INDs), (NDAs), Biologics License (BLAs) to US Food Administration. However, no comprehensive characterization nature these regarding model details intended applications. To address this gap, landscape...
Comprehensive mechanical properties (high strength, good fatigue resistance and tunable stiffness) are significant for large load-bearing implants, but still remain a challenge in practical applications. Polyetheretherketone (PEEK)-Ti6Al4V interpenetrating phase composites (IPCs) with comprehensive were developed using two-step process: fabricating Ti6Al4V microlattices powder bed fusion (PBF) subsequently manufacturing PEEK-Ti6Al4V IPCs vacuum infiltration. The strut defects the induced by...
An increasing number of thorough QT (TQT) reports are being submitted to the US Food and Drug Administration's interdisciplinary review team for (IRT-QT), requiring time-intensive quantitative analyses by a multidisciplinary within 45 days. This calls systematic learning guide future trials policies standardizing automating improve efficiency, provide consistent advice, enable pooled data answer key regulatory questions. The interval represents time from initiation ventricular depolarization...
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for treatment of advanced renal cell carcinoma (RCC) in patients who have received prior antiangiogenic therapy. The approval was based on data from one randomized, open-label, multicenter study which with RCC had therapy were treated either 60 mg orally once daily (n = 330) or everolimus 10 328). major efficacy outcome measure progression-free survival (PFS) as assessed by a blinded independent radiology review...