A5005182956- Plant-based Medicinal Research
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
- Pharmaceutical studies and practices
- Statistical Methods in Clinical Trials
- Pharmacogenetics and Drug Metabolism
- Monoclonal and Polyclonal Antibodies Research
- HER2/EGFR in Cancer Research
- Forensic Toxicology and Drug Analysis
- Antibiotics Pharmacokinetics and Efficacy
- Alcohol Consumption and Health Effects
- Multiple Myeloma Research and Treatments
- Colorectal Cancer Treatments and Studies
- Cancer Genomics and Diagnostics
- Cancer Treatment and Pharmacology
- Virus-based gene therapy research
- Viral Infectious Diseases and Gene Expression in Insects
- Cancer Immunotherapy and Biomarkers
- Pharmaceutical Economics and Policy
- Diabetes Treatment and Management
- Cancer therapeutics and mechanisms
- Neurological Disorders and Treatments
- Atrial Fibrillation Management and Outcomes
- Innovative Microfluidic and Catalytic Techniques Innovation
- Protein Degradation and Inhibitors
Amgen (United States)
2015-2024
Columbus Oncology and Hematology Associates
2015-2021
University of Florida
2015-2020
American College
2019
Indian Institute of Technology Dhanbad
2018
American College of Clinical Pharmacy
2018
National Institutes of Health Clinical Center
2017
Reckitt Benckiser (United States)
2016-2017
University of Maryland, Baltimore
2005-2014
Bristol-Myers Squibb (Germany)
2011-2013
Apixaban is an oral, direct, factor-Xa inhibitor approved for thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and prevention of stroke systemic embolism with non-valvular atrial fibrillation. This open label, parallel group study investigated effects extremes body weight on apixaban pharmacokinetics, pharmacodynamics, safety tolerability.
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%...
<h3>Background</h3> This open-label, first-in-human, phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of AMG 228, an agonistic human IgG1 monoclonal antibody targeting glucocorticoid-induced tumor necrosis factor receptor−related protein (GITR), in patients with refractory advanced solid tumors. <h3>Methods</h3> 228 was administered intravenously every 3 weeks (Q3W). Dose escalation two stages: single-patient cohorts (3, 9, 30,...
Abstract With the promise of a potentially single‐dose curative regimen, CAR‐T cell therapies have brought paradigm shift in treatment and management hematological malignancies with 6 approved products USA. However, there are no for solid tumors. Herein, we report clinical pharmacology profile AMG 119, first therapy targeting delta‐like ligand 3 (DLL3), patients relapsed/refractory (R/R) small lung cancer (SCLC). 119 demonstrated robust cellular expansion long‐lasting persistence favorable...
Abstract Despite numerous reports citing the acute hepatotoxicity caused by 3,4‐methylenedioxymethamphetamine (MDMA) (ecstasy), underlying mechanism of organ damage is poorly understood. We hypothesized that key mitochondrial proteins are oxidatively modified and inactivated in MDMA‐exposed tissues. The aim this study was to identify investigate inactivation proteins, prior extensive dysfunction liver following MDMA exposure. MDMA‐treated rats showed abnormal histology with significant...
Regulatory agencies currently recommend itraconazole (ITZ) as a strong cytochrome P450 3A (CYP3A) inhibitor for clinical drug-drug interaction (DDI) studies. This work by an International Consortium Innovation and Quality in Pharmaceutical Development working group (WG) is to develop verify mechanistic ITZ physiologically-based pharmacokinetic model provide recommendations optimal DDI study design based on simulations. To support development verification, vitro PK data its metabolites were...
Objective: Cornea-related adverse events pose a significant risk for oncology patients treated with systemic therapeutic proteins (TPs), including monoclonal antibodies (mAbs). Data on TP distribution in the human cornea is scarce. Nonclinical studies often lump and limbus other eye tissues, obscuring detailed biodistribution insights these key tissues [1]. Recent ocular-PBPK models, show less than 4% of serum levels exogenous mAbs reach via aqueous humor, while early research endogenous...
Objectives: Bispecific T cell engagers (Bi-TCEs) have revolutionized the landscape of cancer treatment across solid and liquid tumors. Based on mechanism action, cytokine elevations after initial doses Bi-TCEs in oncology patients can result potential cytochrome (CYP) 450 based drug-drug interaction (DDI), albeit elevation is transient nature. Hence risk could be theoretical but yet unknown. Over decades, we gained extensive clinical development experience with 3 generations molecules...
Objectives: Progression-free survival (PFS) is an important endpoint in oncology trials that determined by applying the RECIST criteria to longitudinal measurements of tumor size and appearance new tumors. While traditionally modeled as a whole, practitioners have recently begun directly modeling underlying components PFS via mechanistic models (Yu, 2020) (Baaz, 2023). Specifically, they use growth inhibition (TGI) model target lesions over time, jointly hazard function progression nontarget...
Background: T-cell engagers (TCEs) represent a transformative approach in cancer therapy, designed to redirect the immune system selectively target cells. Despite their promising efficacy, activation of poses risk rapid release cytokines, leading occurrence Cytokine Release Syndrome (CRS), potentially severe concerns around patient safety. Several semi-mechanistic modeling approaches have been employed understand cytokines context drug action [1,2], however extending these predictive model...
Objectives: The FDA recently announced the continuation of MIDD Paired Meeting Program as part Prescription Drug User Fee Act VII. Here we aim to highlight key take home message from recent publication [1] prepared by sponsors that are members International Consortium for Innovation and Quality in Pharmaceutical Development with objective providing relevant information will optimize value Program. primary is support good decision-making drug development. Secondary objectives can include...
Apixaban is an oral, selective, direct factor Xa inhibitor approved for thromboprophylaxis after orthopedic surgery and stroke prevention in patients with atrial fibrillation, under development treatment of venous thromboembolism. This study investigated the effect a gastric acid suppressant, famotidine (a histamine H2-receptor antagonist), on pharmacokinetics apixaban healthy subjects.This two-period, two-treatment crossover randomized 18 subjects to receive single oral dose 10 mg without...