A5100420671- Acute Myeloid Leukemia Research
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
- Cutaneous lymphoproliferative disorders research
- Monoclonal and Polyclonal Antibodies Research
- Statistical Methods in Clinical Trials
- Toxin Mechanisms and Immunotoxins
- Muscle and Compartmental Disorders
- Nanoparticle-Based Drug Delivery
- Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Blood transfusion and management
- Rheumatoid Arthritis Research and Therapies
- Hormonal and reproductive studies
- Prostate Cancer Treatment and Research
- Dermatologic Treatments and Research
- Integrated Circuits and Semiconductor Failure Analysis
- Peptidase Inhibition and Analysis
- Cardiac Arrest and Resuscitation
- Protein Degradation and Inhibitors
- Esophageal and GI Pathology
- CRISPR and Genetic Engineering
- Genomics and Rare Diseases
- Prostate Cancer Diagnosis and Treatment
- Multiple Myeloma Research and Treatments
- Advancements in Semiconductor Devices and Circuit Design
Sichuan University
2023
Center for Drug Evaluation and Research
2017-2022
United States Food and Drug Administration
2018-2022
Peking University
2020
First Affiliated Hospital of Harbin Medical University
2017
Harbin Medical University
2017
Cleveland Clinic
2006
Chinese PLA General Hospital
2005
Stored red cells undergo progressive structural and functional changes over time. We tested the hypothesis that serious complications mortality after cardiac surgery are increased when transfused stored for more than 2 weeks.We examined data from patients given red-cell transfusions during coronary-artery bypass grafting, heart-valve surgery, or both between June 30, 1998, January 2006. A total of 2872 received 8802 units blood had been 14 days less ("newer blood"), 3130 10,782 ("older...
On August 30, 2017, the U.S. Food and Drug Administration approved Actemra (tocilizumab, Genentech, Inc., South San Francisco, CA) for treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS) in adults pediatric patients 2 years age older. The approval was based on a retrospective analysis data who developed CRS after with CTL019 KTE-C19 prospective clinical trials. Evaluable had been treated intravenous tocilizumab 8 mg/kg (12...
Abstract Tagraxofusp-erzs (Elzonris, Stemline) is a cytotoxin that targets CD123-expressing cells. On December 21, 2018, FDA approved tagraxofusp-erzs for the treatment of blastic plasmacytoid dendritic cell neoplasms (BPDCN) in adult and pediatric patients 2 years older. Approval was based on response rate single-arm trial, Study STML-401-0114; pivotal cohort included 13 with treatment-naïve BPDCN who received monotherapy. The complete or clinical (CR/CRc) 54% (95% CI: 25%–81%), median...
Abstract On August 5, 2020, the FDA granted accelerated approval to belantamab mafodotin-blmf (BLENREP; GlaxoSmithKline) for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and immunomodulatory agent. Substantial evidence effectiveness was obtained from phase II, multicenter DREAMM-2 trial. Patients mafodotin 2.5 3.4 mg/kg intravenously once every 3...
We present an application of a quantitative systems pharmacology ( QSP ) model to support regulatory decision, specifically in assessing the adequacy proposed dosing regimen. On January 23, 2015, US Food and Drug Administration FDA approved Natpara (human parathyroid hormone PTH )) control hypocalcemia patients with hypoparathyroidism. Clinical trial results indicated that although once‐daily reduced calcium vitamin D dose requirement while maintaining normocalcemia, regimen was not adequate...
Objective Olecranon osteotomy and paratricipital approaches were widely used in the treatment of type C distal humerus fracture but some disadvantages exist, so a combined medial lateral approach was designed. The objective this study to investigate compare clinical outcomes with open reduction internal fixation fractures. Methods From May 2018 April 2020, 37 patients who accepted our hospital enrolled study. All cases randomly divided into two groups according surgical approach: group (19...
American College of Rheumatology (ACR) response criteria is used to assess improvement in tender and swollen joint counts 3 the 5 core measures (acute-phase reactant, physician global assessment, patient pain, physical function). From clinical trial data on approved biological products for treatment rheumatoid arthritis, population pharmacokinetic/pharmacodynamic models were developed quantitatively describe relationship between exposure rates individual components ACR criteria. The then...
Population pharmacokinetic/pharmacodynamic (PK/PD) models were developed to quantitate the exposure-response relationships using continuous longitudinal data on American College of Rheumatology (ACR) subcomponents, that is, tender-joint count (TJC), swollen-joint (SJC), C-reactive protein, patient's assessment pain, global disease activity, physician's and physical function for 5 biologics approved use in rheumatoid arthritis. The then used simulate time courses clinical outcomes following...
The risk in terms of safety or diminished efficacy switching between an originator biological product and a proposed interchangeable is important consideration for interchangeability evaluation the regulatory framework. This simulation study evaluated impact several design scenarios on pharmacokinetic (PK) assessment virtual product. Our results show that (1) at least 3 switches are needed to optimize detection potential PK differences, (2) initial incidence antidrug antibodies after...
On August 30, 2017, the U.S. Food and Drug Administration approved tocilizumab for treatment of severe or life-threatening chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS) in adults pediatric patients 2 years age older. Approval was based on findings a retrospective analysis outcomes with CD19-positive hematological malignancies treated CTL019 KTE-C19 CAR cells. Evaluable had been 8 mg/kg (12 < 30 kg) without additional high-dose corticosteroids CRS; only first...
Koch, Colleen Gorman MD, MS; Li, Liang PhD; Duncan, Andra I. MD; Mihaljevic, Tomislav Cosgrove, Delos M. Loop, Floyd D. Starr, Norman J. Blackstone, Eugene H. MD Author Information
<div>Abstract<p>On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and cytarabine in fixed combination, for treatment adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or (AML) myelodysplasia-related changes (AML-MRC). Approval was based on data from Study CLTR0310-301, randomized, multicenter, open-label, active-controlled trial comparing standard...
<p>Supplemental Table S1: Grouped Terms for Adverse Reactions on Study 301</p>
<div>Abstract<p>On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and cytarabine in fixed combination, for treatment adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or (AML) myelodysplasia-related changes (AML-MRC). Approval was based on data from Study CLTR0310-301, randomized, multicenter, open-label, active-controlled trial comparing standard...
<p>Supplemental Table 2: Prolonged Cytopenia on Study 301</p>
<p>Supplemental Table 2: Prolonged Cytopenia on Study 301</p>
<p>Supplemental Table S1: Grouped Terms for Adverse Reactions on Study 301</p>
<div>Abstract<p>Tagraxofusp-erzs (Elzonris, Stemline) is a cytotoxin that targets CD123-expressing cells. On December 21, 2018, FDA approved tagraxofusp-erzs for the treatment of blastic plasmacytoid dendritic cell neoplasms (BPDCN) in adult and pediatric patients 2 years older. Approval was based on response rate single-arm trial, Study STML-401-0114; pivotal cohort included 13 with treatment-naïve BPDCN who received monotherapy. The complete or clinical (CR/CRc) 54% (95% CI:...
<div>Abstract<p>Tagraxofusp-erzs (Elzonris, Stemline) is a cytotoxin that targets CD123-expressing cells. On December 21, 2018, FDA approved tagraxofusp-erzs for the treatment of blastic plasmacytoid dendritic cell neoplasms (BPDCN) in adult and pediatric patients 2 years older. Approval was based on response rate single-arm trial, Study STML-401-0114; pivotal cohort included 13 with treatment-naïve BPDCN who received monotherapy. The complete or clinical (CR/CRc) 54% (95% CI:...
Objective To summary safety and nursing interventions of intra-hospital transport critical cardiovascular patients. Methods Totals 237 patients in First Affiliated Hospital Harbin Medical University from September 2012toSeptember 2015 were as objects study. Through assessment before transport, we should fully prepared be careful for transit monitoring observation vital signs, prevention treatment adverse events time to implement the nurse make a good record...