A5004249530- Inhalation and Respiratory Drug Delivery
- Drug Solubulity and Delivery Systems
- Statistical Methods in Clinical Trials
- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- Asthma and respiratory diseases
- Biosimilars and Bioanalytical Methods
- Advanced Drug Delivery Systems
- Pharmaceutical studies and practices
- Allergic Rhinitis and Sensitization
- Nasal Surgery and Airway Studies
- Antibiotics Pharmacokinetics and Efficacy
- Advancements in Transdermal Drug Delivery
- Computational Drug Discovery Methods
- RNA and protein synthesis mechanisms
- Pharmaceutical Economics and Policy
- Protein Interaction Studies and Fluorescence Analysis
- Analytical Methods in Pharmaceuticals
- Protein purification and stability
- Analytical Chemistry and Chromatography
- Crystallization and Solubility Studies
- Aerosol Filtration and Electrostatic Precipitation
- Attention Deficit Hyperactivity Disorder
- Pharmacological Effects and Toxicity Studies
- Obstructive Sleep Apnea Research
United States Food and Drug Administration
2016-2025
Center for Drug Evaluation and Research
2016-2025
University of Michigan
2015
Stanford University
2011
California Institute of Technology
2011
This report summarizes the proceedings of Session 1 one-day public workshop titled "Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development" hosted by U.S. Food Administration (FDA) Center Research on Complex Generics (CRCG) October 12, 2023. focuses cutting-edge developments, ongoing challenges, potential solutions field physiologically based pharmacokinetic (PBPK) absorption modeling systemic gastrointestinal (GI) locally acting oral drug products, as well...
This study aimed to introduce a one-dimensional (1D) computational fluid dynamics (CFD) model for airway resistance and lung compliance examine the relationship between resistance, pressure, regional flow distribution. We employed five healthy asthmatic subjects who had dynamic computed tomography (CT) scans (4D CT) along with two static at total capacity functional residual capacity. Fractional air-volume change ([Formula: see text]) from 4D CT was used validation of 1D CFD model. extracted...
Bupropion's metabolism and the formation of hydroxybupropion in liver by cytochrome P450 2B6 (CYP2B6) has been extensively studied; however, erythro/threohydrobupropion intestine carbonyl reductases (CR) not well characterized. The purpose this investigation was to compare relative contribution two pathways bupropion (by CYP2B6 CR) subcellular fractions identify CRs responsible for intestine. results showed that microsome generated highest amount (<i>V</i><sub>max</sub> = 131 pmol/min per...
Quantitative methods and modeling (QMM) are rapidly demonstrating their potential to support generic drug development assessment. This commentary is based on the public input from Generic Drug User Fee Amendments (GDUFA) Science Research Initiative Public Workshop held in May 2022, which recognized implementation of model-integrated evidence (MIE) as a high research priority for next 5 years. On 9 10, US Food Administration (FDA) hosted Fiscal Year (FY) 2022 commitment under 2017 (GDUFA II)....
This report summarizes the proceedings for Day 3 of workshop titled "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices Drug Product Quality: Regulatory and Industry Perspectives". day focused on current future drug product quality applications PBBM from innovator generic industries as well regulatory agencies perspectives. The presentations, which included several case studies, covered in development, virtual bioequivalence trials to support formulation bridging utility...
The programming of cellular networks to achieve new biological functions depends on the development genetic tools that link presence a molecular signal gene-regulatory activity. Recently, set engineered RNA controllers was described enabled predictable tuning gene expression in yeast Saccharomyces cerevisiae through directed cleavage transcripts by an RNase III enzyme, Rnt1p. Here, we describe strategy for building class sensing-actuation devices based direct integration aptamers into region...
Background: Four computed tomography (CT) imaging-based clusters have been identified in a study of the Severe Asthma Research Program (SARP) cohort and significantly correlated with clinical demographic metrics (J Allergy Clin Immunol 2017; 140:690-700.e8). We used computational fluid dynamics (CFD) model to investigate air flow aerosol deposition within imaging archetypes representative four clusters. Methods: CFD simulations for 1-8 μm particle transport were performed using CT-based...
Abstract The U.S. Food and Drug Administration (FDA) the Center for Research on Complex Generics (CRCG) hosted a public workshop May 2–3, 2024, titled “Considerations Potential Regulatory Applications Model Master File (Lachaine et al Can J Psychiatry. 60:S40-S47, 2015)”. aimed to discuss application of (MMF) concept in regulatory submissions that contain model integrated evidence (MIE), improving sharing, standardization, consistency, efficiency. On Day 1, there was session dedicated MMF...