A5076957747- Drug Solubulity and Delivery Systems
- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- Analytical Methods in Pharmaceuticals
- Analytical Chemistry and Chromatography
- Pharmaceutical studies and practices
- Statistical Methods in Clinical Trials
- Protein purification and stability
- Crystallization and Solubility Studies
- Computational Drug Discovery Methods
- HIV/AIDS drug development and treatment
- Advanced Drug Delivery Systems
- Pharmacological Effects and Toxicity Studies
- HER2/EGFR in Cancer Research
- Biosimilars and Bioanalytical Methods
- Chronic Lymphocytic Leukemia Research
- Biochemical and Molecular Research
- Hepatitis C virus research
- Chronic Myeloid Leukemia Treatments
- Innovative Microfluidic and Catalytic Techniques Innovation
- Glioma Diagnosis and Treatment
- Receptor Mechanisms and Signaling
- Advanced Breast Cancer Therapies
- Liver Disease Diagnosis and Treatment
- Gastrointestinal motility and disorders
Merck & Co., Inc., Rahway, NJ, USA (United States)
2020-2025
Novartis (United States)
2010-2023
Tris Pharma (United States)
2018-2023
Husson University
2021
University of Florida
2018
Columbus Oncology and Hematology Associates
2018
Foundation for Biomedical Research
2017
University of Manchester
2016
Novartis (Switzerland)
2009-2014
Pfizer (United States)
2004-2007
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are on integration physiological, pharmacological, pharmaceutical data simulate predict behavior in vivo. Effective utilization PBBM requires consistent approach model development, verification, validation, application. Currently, only one country has draft guidance document for PBBM,...
Inhibition of mutant IDH1 is being evaluated clinically as a promising treatment option for various cancers with hotspot mutation at Arg132. Having identified an allosteric, induced pocket IDH1R132H, we have explored 3-pyrimidin-4-yl-oxazolidin-2-ones inhibitors in vivo modulation 2-HG production and potential brain penetration. We report here optimization efforts toward the identification clinical candidate IDH305 (13), potent selective inhibitor that has demonstrated exposure rodents....
The predictive performance of physiologically‐based pharmacokinetics (PBPK) models for (PK) in renal impairment (RI) and hepatic (HI) populations was evaluated using clinical data from 29 compounds with 106 organ study arms were collected 19 member companies the International Consortium Innovation Quality Pharmaceutical Development. Fifty RI 56 HI varying degrees insufficiency along control evaluated. For RI, area under curve (AUC) ratios to healthy predicted within twofold observed > 90%...
Abstract The effect of food on pharmacokinetic properties drugs is a commonly observed occurrence affecting about 40% orally administered drugs. Within the pharmaceutical industry, significant resources are invested to predict and characterize clinically relevant effect. Here, predictive performance physiologically based (PBPK) models was assessed via de novo mechanistic absorption for 30 compounds using controlled, pre-defined in vitro , modeling methodology. Compounds which known be...
Typically, colonic absorption of a drug is mandatory for sustained release formulation to hold the drug's plasma level more than 12 or 24 h above minimum therapeutic concentration (efficacy). According Drugs@FDA, only 7.4% oral drugs are extended forms probably showing absorption. Therefore an early determination using IntelliCap® in animals humans will provide information initiate stop SR form development. Diltiazem (60 mg) used swallowable and marketed from Mylan (coated beads). A human...