A5058442299- Drug Transport and Resistance Mechanisms
- Antibiotics Pharmacokinetics and Efficacy
- Pharmacogenetics and Drug Metabolism
- Protein Interaction Studies and Fluorescence Analysis
- Advanced Drug Delivery Systems
- Drug Solubulity and Delivery Systems
- Gout, Hyperuricemia, Uric Acid
- Pharmacological Effects of Natural Compounds
- Pharmaceutical studies and practices
- Advancements in Transdermal Drug Delivery
- Liver Disease and Transplantation
- Receptor Mechanisms and Signaling
- Renal Transplantation Outcomes and Treatments
- Diabetes Treatment and Management
- Innovative Microfluidic and Catalytic Techniques Innovation
- Safe Handling of Antineoplastic Drugs
- Pharmacological Effects and Toxicity Studies
- Intraocular Surgery and Lenses
- Ocular Infections and Treatments
- Statistical Methods in Clinical Trials
- Gastroesophageal reflux and treatments
- Ginseng Biological Effects and Applications
- Protein purification and stability
Center for Drug Evaluation and Research
2017-2025
United States Food and Drug Administration
2017-2025
Chongqing Technology and Business University
2015
Our recent studies have shown that chronic kidney disease (CKD) affects the pharmacokinetics (PKs) of cytochrome P450 (CYP)2D6‐metabolized drugs, whereas effects were less evident on CYP3A4/5. Therefore, effect CKD disposition CYP1A2‐metabolized, CYP2C8‐metabolized, CYP2C9‐metabolized, CYP2C19‐metabolized, and organic anion‐transporting polypeptide (OATP)‐transported drugs was investigated. We identified dedicated with 6, 5, 4, 12 “model” substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, OATP,...
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 development of generic ophthalmic drug products with complex formulations is challenging due to the complexity ocular system and a lack sensitive testing evaluate interplay its physiology drugs. New methods are needed facilitate products. Ocular physiologically based pharmacokinetic (O-PBPK) models can provide insight into partitioning in eye tissues that usually not accessible and/or sample humans. This study aims demonstrate utility an PBPK model predict human exposure following...
Graphical Abstract
Abstract Background The development of generic ophthalmic drug products is challenging due to the complexity ocular system, and a lack sensitive testing evaluate interplay physiology with formulations. While measurements concentration at site action in humans are typically sparse, these more easily obtained rabbits. purpose this study demonstrate utility an physiologically based pharmacokinetic (PBPK) model for translation exposure from rabbit human. Method Ocular Compartmental Absorption...
Abstract Purpose The purpose of this study is to show how the Ocular Compartmental Absorption & Transit (OCAT™) model in GastroPlus ® can be used characterize ocular drug pharmacokinetic performance rabbits for ointment formulations. Methods A newly OCAT™ developed fluorometholone, as well a previously verified dexamethasone, were aqueous humor (AH) concentration following administration multiple formulations rabbit. uses parameters: application surface area (SA), fitted time, and...
Identifying critical attributes for complex locally acting ophthalmic formulations and establishing in vitro-in vivo correlations can facilitate selection of appropriate thresholds formulation changes that reflect lack impact on performance. In this study the marketed antiglaucoma product Azopt® (1% brinzolamide suspension) five other varying particle size distributions apparent viscosities were topically administered rabbits, their ocular pharmacokinetics was determined multiple tissues....
Oral extended-release (ER) dosage forms have been used to sustain blood drug levels, reduce adverse events, and improve patient compliance. We investigated potential effects of comedication on pharmacokinetic exposure nifedipine ER products with different formulation designs manufacturing processes. A clinical study compared a generic version tablet pH-dependent dissolution behavior an osmotic pump product pH independent release under fasting condition. In this study, two were tested or...
Abstract Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and nifedipine extended‐release formulations, where systemic exposure was increased subjects after multiple‐dose pretreatment omeprazole. However, mechanism observed DDIs omeprazole not been well‐understood, as DDI may also be mediated through CYP3A4 enzyme...