A5000623880- Lysosomal Storage Disorders Research
- Biosensors and Analytical Detection
- Biosimilars and Bioanalytical Methods
- Antibiotics Pharmacokinetics and Efficacy
- Sphingolipid Metabolism and Signaling
- Carbohydrate Chemistry and Synthesis
- Antibiotic Resistance in Bacteria
- Pesticide Residue Analysis and Safety
- Oral and gingival health research
- Parkinson's Disease Mechanisms and Treatments
- Innovative Microfluidic and Catalytic Techniques Innovation
- Cellular transport and secretion
- Glycosylation and Glycoproteins Research
- Microfluidic and Capillary Electrophoresis Applications
- Diabetes Treatment and Management
- Mass Spectrometry Techniques and Applications
- Trypanosoma species research and implications
- Pancreatitis Pathology and Treatment
- Bacterial biofilms and quorum sensing
- Blood disorders and treatments
- Erythrocyte Function and Pathophysiology
- Advanced Biosensing Techniques and Applications
- Salivary Gland Disorders and Functions
- Studies on Chitinases and Chitosanases
- Advanced Chemical Sensor Technologies
Chiesi (United States)
2023-2025
Sanofi (United States)
2016-2023
Framingham State University
2018-2022
Pfizer (United States)
2010-2013
Cleveland State University
1995
Mayo Clinic
1995
Abstract Olipudase alfa, a recombinant human acid sphingomyelinase (ASM), is an enzyme replacement therapy for the treatment of nonneurologic manifestations deficiency (ASMD). This ongoing, open‐label, long‐term study (NCT02004704) assessed safety and efficacy olipudase alfa following 30 months in five adult patients with ASMD. There were no deaths, serious or severe events, discontinuations during treatment. The majority adverse events mild included headache, nausea, abdominal pain. No...
Venglustat is a small-molecule glucosylceramide synthase (GCS) inhibitor designed to reduce the production of (GL-1) and thus expected substantially formation glucosylceramide-based glycosphingolipids. Because its effect on glycosphingolipid formation, GCS inhibition has therapeutic potential across many disorders affecting metabolism. Therefore, venglustat under development for substrate reduction therapy in multiple diseases, including Gaucher disease type 3, Parkinson's associated with...
The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place New Orleans, LA, USA April 1–5, with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – full immersion week bioanalysis, biomarkers, immunogenicity gene therapy. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing...
Abstract An estimated 500,000 individuals in the US, mostly steroid-dependent asthmatics, suffer severe adverse reactions to sulfites foods, beverages, and pharmaceutical products. In an attempt understand pathogenesis of sulfite hypersensitivity, we have developed assay for determination total serum by utilizing: (a) reductive release protein-bound sulfite; (b) derivatization free with monobromobimane; (c) separation sulfite-bimane from thiol-bimanes reversed-phase HPLC; (d) quantitation...
Dr Allena Ji is the Director of Bioanalytical Services, XenoBiotic Laboratories, Inc., NJ, USA. She has worked in bioanalytical field for many years and accumulated rich experience LC-MS/MS method development, validation sample analysis under GLP compliance large pharmaceutical company contract laboratory settings. In past 10 years, at Pfizer (Legacy Wyeth) investigated small-molecule drug candidates their nonspecific binding urine assays. Nonspecific compounds results a severe...
The 17
The liver is a major site of lipoprotein synthesis and metabolism. Liver manifestations chronic visceral ASMD include hepatomegaly, fibrosis, elevated enzymes pro-atherogenic lipid profile. Measurements sphingomyelin (SM) levels in biopsies lyso-SM plasma were used as pharmacodynamic biomarkers. Five adult patients with enrolled 26-week phase 1b trial enzyme replacement therapy (ERT) olipudase alfa (NCT01722526) followed by an ongoing long-term extension study (NCT02004704). We compare the...
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held 27 September to 1 October 2021. Even with a last-minute move from in-person virtual, an overwhelmingly high number nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), multiple regulatory agencies still eagerly convened actively discuss most current topics interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned week...
The 2018 12th Workshop on Recent Issues in Bioanalysis (12th WRIB) took place Philadelphia, PA, USA April 9-13, with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion bioanalysis, biomarkers immunogenicity. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing approaches address the most current...
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually June 15-29, 2020 with an attendance over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days order to allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene...
The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place Atlanta, GA, USA September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week order allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy...
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place San Antonio, TX, USA May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week allow an exhaustive thorough coverage all major issues bioanalysis biomarkers, immunogenicity, gene therapy, cell therapy...
We tested a novel, orally active inhibitor of plasminogen activator inhibitor-1 (PAI-1) in canine model electrolytic injury. Dogs received by oral gavage either vehicle (control) or the PAI-1 PAI-039 [{1-benzyl-5-[4-(trifluoromethoxy)phenyl]-1H-indol-3-yl}(oxo)acetic acid] (1, 3, and 10 mg/kg) were subjected to injury coronary artery. caused prolongation time occlusion (control, 31.7 +/- 6.3 min; 3 mg/kg PAI-039, 66.0 6.4 mg/kg, 56.7 7.4 n = 5-6; p < 0.05) reduced thrombus weight 7.6 1.5 mg;...
trans-3'-Hydroxycotinine (THOC) has been recognized as the most abundant metabolite of nicotine. In an attempt to assess THOC and cotinine (COT) concentrations during nicotine transdermal therapy, we developed a new quantitative gas chromatography-mass spectrometry (GC-MS) method for simultaneous determination total free COT in human urine. The utilizes following: (a) hydrolysis conjugated by beta-glucuronidase; (b) basic extraction with mixed dichloromethane n-butyl acetate; (c)...
Background: To develop and validate a sensitive novel bioanalytical method for measuring tigecycline concentrations in human skin using LC–MS/MS. Results: The utilizes addition of stabilizing agent to the or surrogate (human liver rat skin), homogenization strong acidic-methanol extraction solvent, centrifugation suspension, filtration suspension supernatant, separation by LC (Polaris™ C18-A 50 × 2.0 mm), detection MS/MS. Linearity was 50–20,000 ng/g, sample size 100 mg. intra-and inter-day...
Abstract The goal of the this study was to re‐evaluate tigecycline bone concentrations in subjects undergoing elective orthopedic surgery, using multiple doses and a more robust assay than used previous study. Each subject received three intravenous (one 100‐mg infusion followed by two 50‐mg infusions, each administered over 30 minutes). A single sample collected from at one following times: 1, 2, 4, 6, 8, or 12 hours after third dose. Four blood samples were subject: before first dose,...
Glucosylceramide, an efficacy biomarker for Gaucher Type 1 disease, exhibits poor solubility in polar solvents and whole blood which makes it difficult to prepare a homogenous standard.We developed novel method using standard addition approach by spiking small volume of analyte solution on the surface prespotted dried spot. The spots were punched out subsequent extraction LC-MS/MS analysis. assay performance met all validation acceptance criteria. Glucosylceramide concentrations 50 paired...
Glucosylceramide (GL-1) level in human has been considered as a surrogate biomarker for enzyme replacement and substrate reduction therapies (ERT SRT) Gaucher Fabry patients. Due to the high endogenous of GL-1 plasma, it is difficult achieve analytical sensitivity plasma below normal (1.7 μg/mL 6.6 μg/mL) when using standard addition method regular matrix curve. A assay with LLOQ at 0.1 was developed validated delipidized so that patient concentrations are reference range can be measured...
Selection of the appropriate matrix for standard curve is critical an accurate and sensitive biomarker method. Slope a key factor parallelism assessment between tested authentic LC-MS/MS assays. Here authors have established slope criteria using generic equation endogenous level achieving assay sensitivity. The difference criterion from -13.0 to +17.6% LC-MS assays with ± 15% bias criteria. When ratio concentration in lower limit quantitation <4.0, achievable. If these are met, can be used...