A5101695649- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- Statistical Methods in Clinical Trials
- Pharmaceutical studies and practices
- Pharmacological Effects and Toxicity Studies
- Gastric Cancer Management and Outcomes
- Analytical Chemistry and Chromatography
- Blood Pressure and Hypertension Studies
- Astrophysical Phenomena and Observations
- Parkinson's Disease Mechanisms and Treatments
- Drug-Induced Hepatotoxicity and Protection
- Computational Drug Discovery Methods
- Diabetes Treatment and Management
- MRI in cancer diagnosis
- Colorectal Cancer Treatments and Studies
- Drug Solubulity and Delivery Systems
- HIV/AIDS drug development and treatment
- Gamma-ray bursts and supernovae
- SARS-CoV-2 and COVID-19 Research
- Stellar, planetary, and galactic studies
- Eicosanoids and Hypertension Pharmacology
- Health Systems, Economic Evaluations, Quality of Life
- Neurological disorders and treatments
- Advanced Neuroimaging Techniques and Applications
- Diet and metabolism studies
Sichuan Cancer Hospital
2022-2024
University of Electronic Science and Technology of China
2022-2024
Sichuan University
2011-2024
Sichuan Provincial Library
2011-2024
Acorda Therapeutics (United States)
2014-2023
Affiliated Hospital of Guizhou Medical University
2023
Guiyang Medical University
2023
Gates Foundation
2017-2023
Second Affiliated Hospital of Xi'an Jiaotong University
2017-2023
Liaoning University
2014-2022
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans evaluate effects intrinsic (e.g., organ dysfunction, age, genetics) extrinsic drug-drug interactions) factors, alone or combinations, on drug exposure. The use this increasing at all stages development process. This report reviews recent instances PBPK decision-making during regulatory review. examples are Center for Drug Evaluation Research several...
We present multiband photometry of 185 type-Ia supernovae (SNe Ia), with over 11,500 observations. These were acquired between 2001 and 2008 at the F. L. Whipple Observatory Harvard-Smithsonian Center for Astrophysics (CfA). This sample contains largest number homogeneously observed reduced nearby SNe Ia (z ≲ 0.08) published to date. It more than doubles sample, bringing SN cosmology point where systematic uncertainties dominate. Our natural system has a precision ≲0.02 mag in BVRIr'i' ≲0.04...
We present UBVRI photometry of 44 Type Ia supernovae (SNe Ia) observed from 1997 to 2001 as part a continuing monitoring campaign at the Fred Lawrence Whipple Observatory Harvard-Smithsonian Center for Astrophysics. The data set comprises 2190 observations and is largest homogeneously reduced sample SNe date, nearly doubling number well-observed, nearby with published multicolor CCD light curves. large U-band unique addition, important connections high redshift. decline rate SN curves...
On April 29, 2014, the FDA granted accelerated approval to ceritinib (ZYKADIA; Novartis Pharmaceuticals Corporation), a breakthrough therapy-designated drug, for treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant crizotinib. The was based single-arm multicenter trial enrolling 163 ALK-positive NSCLC had disease progression (91%) intolerance Patients received at starting dose 750 mg...
Background Non-invasive imaging biomarkers of cellular proliferation hold great promise for quantifying response to personalized medicine in oncology. An emerging approach assess tumor utilizes the positron emission tomography (PET) tracer 3'-deoxy-3'[18F]-fluorothymidine, [18F]-FLT. Though several studies have associated serial changes [18F]-FLT-PET with elements therapeutic response, degree which quantitatively reflects proliferative index has been continuously debated more that a decade....
A temporal diffusion MRI spectroscopy based approach has been developed to quantify cancer cell size and density in vivo.A novel imaging microstructural parameters using limited spectrally edited (IMPULSED) method selects a specific spectral window for an accurate quantification of sizes ranging from 10 20 μm common solid tumors. In practice, it is achieved by combination single long time pulsed gradient spin echo (PGSE) three low-frequency oscillating (OGSE) acquisitions. To validate our...
Abstract On March 13, 2017, the FDA approved ribociclib (KISQALI; Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer. The approval was based on randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2). A total 668 patients were randomized to...
Chronic alcohol consumption may potentiate acetaminophen (APAP) hepatotoxicity through enhanced formation of N -acetyl- p -benzoquinone imine (NAPQI) via induction cytochrome P450 2E1 (CYP2E1). However, CYP2E1 appears to be insufficient explain the claimed magnitude interaction. We assessed role selective depletion liver mitochondrial glutathione (GSH) by chronic ethanol. Rats were fed Lieber-DeCarli diet for 10 days or 6 weeks. APAP toxicity in slices (% glutathione- S -transferase α...
Objective. The volume of subcutaneous xenograft tumors is an important metric disease progression and response to therapy in preclinical drug development. Noninvasive imaging technologies suitable for measuring are increasingly available, yet manual calipers, which susceptible inaccuracy bias, routinely used. goal this study was quantify compare the accuracy, precision, inter-rater variability tumor assessment by caliper measurements ultrasound imaging. Methods. Subcutaneous derived from...
Nine static models (seven basic and two mechanistic) their respective cutoff values used for predicting cytochrome P450 3A (CYP3A) inhibition, as recommended by the US Food Drug Administration European Medicines Agency, were evaluated using data from 119 clinical studies with orally administered midazolam a substrate. Positive predictive error (PPE) negative (NPE) rates to assess model performance, based on of 1.25-fold change in area under curve (AUC) inhibitor. For reversible total or...
Rivaroxaban is an oral Factor Xa inhibitor. The primary objective of this communication was to quantitatively predict changes in rivaroxaban exposure when individuals with varying degrees renal impairment are co-administered another drug that both a P-gp and moderate CYP3A4 inhibitor.A physiologically based pharmacokinetic (PBPK) model developed simulate pharmacokinetics young (20-45 years) or older (55-65 subjects normal function, mild, severe impairment, without concomitant use the...
Altered pharmacokinetics (PK) in subjects with chronic kidney disease (CKD) may lead to dosing adjustment of certain drugs CKD. It can be valuable quantitatively predict PK CKD for the management drug these subjects. We developed physiologically based pharmacokinetic (PBPK) models seven renally eliminated drugs: adefovir, avibactam, entecavir, famotidine, ganciclovir, oseltamivir carboxylate, and sitagliptin. These are all substrates renal organic anion transporters (OATs). Drug verified...
Chronic kidney disease ( CKD ) differentially affects the pharmacokinetics PK of nonrenally cleared drugs via certain pathways (e.g., cytochrome P450 CYP )2D6); however, effect on 2C8‐mediated clearance is not well understood because overlapping substrate specificity with hepatic organic anion‐transporting polypeptides OATP s). This study used physiologically based pharmacokinetic PBPK modeling to delineate potential changes in 2C8 or 1B activity patients . Drugs analyzed are predominantly...
The US Food and Drug Administration draft drug interaction guidance recommends that 400 mg ketoconazole (KTZ) be administered once daily for several days (QD400) maximal CYP3A inhibition. Some investigators suggest a single dose of (SD400) KTZ is sufficient given its short half-life (t(1/2) approximately 3-5 hr). To determine the impact regimens on inhibition, we simulated AUC fold-change (AUCR) in presence SD400, QD400, or 200 twice-daily (BID200) theoretical substrates. Ratios AUCR...