A5013237694- Monoclonal and Polyclonal Antibodies Research
- Colorectal Cancer Treatments and Studies
- Melanoma and MAPK Pathways
- HIV/AIDS drug development and treatment
- HER2/EGFR in Cancer Research
- Glycosylation and Glycoproteins Research
- CAR-T cell therapy research
- Cancer therapeutics and mechanisms
- Lung Cancer Treatments and Mutations
- Nanoparticle-Based Drug Delivery
- Pharmacological Effects and Toxicity Studies
- Drug Transport and Resistance Mechanisms
- Inhalation and Respiratory Drug Delivery
- GABA and Rice Research
- PI3K/AKT/mTOR signaling in cancer
- Immunotoxicology and immune responses
- Protist diversity and phylogeny
- Cell Adhesion Molecules Research
- Quinazolinone synthesis and applications
- Pregnancy and Medication Impact
- Antimicrobial Peptides and Activities
- Advanced Radiotherapy Techniques
- Statistical Methods in Clinical Trials
- Graphene and Nanomaterials Applications
- Antibiotic Resistance in Bacteria
Pfizer (United States)
2022-2025
University of Montana
2021-2023
University of California, San Diego
2021-2023
University of North Carolina at Chapel Hill
2018-2022
University of North Carolina Health Care
2018-2021
Kutztown University
1987
Encorafenib is a kinase inhibitor indicated for the treatment of patients with BRAF mutant melanoma and metastatic colorectal cancer. To understand effect food coadministration proton-pump (PPI), in vitro, vivo, silico data were generated to optimize clinical dose, evaluate safety, better oral absorption process under these conditions. Study 1 evaluated on plasma pharmacokinetics, tolerability after single dose encorafenib 100 mg. 2 same end points rabeprazole (PPI perpetrator). The vitro...
Encorafenib is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma colorectal cancer, respectively, selected BRAF V600 mutations. A clinical drug–drug interaction (DDI) study was designed to evaluate effect encorafenib on rosuvastatin, sensitive substrate OATP1B1/3 and breast cancer resistance protein (BCRP), bupropion, CYP2B6 substrate. Coproporphyrin I (CP-I), an endogenous OATP1B1, measured in separate deconvolute mechanism transporter DDI....
Objectives: Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activity approved in combination with encorafenib for the treatment patients unresectable or metastatic melanoma non-small cell lung cancer select BRAF V600 mutations [1]. The primary metabolic pathway accounting binimetinib metabolism glucuronidation via UGT1A1 objectives this analysis were to describe population pharmacokinetics (popPK) evaluate potential...
Objectives: Pexmetinib is a novel dual inhibitor of p38 mitogen-activated protein kinase and endothelial tyrosine receptor, Tie2, under prior investigation in low or intermediate-1 risk myelodysplastic syndrome (MDS) (NCT00916227 NCT01496495). The objectives this analysis were to describe the population pharmacokinetics (popPK) pexmetinib evaluate potential covariates that may be important predictors (PK). Methods: Data from two Phase 1 healthy volunteer studies MDS patients included...
Elranatamab is a BCMA-CD3 bispecific antibody approved for the treatment of relapsed or refractory multiple myeloma. Cytokine release syndrome one most common adverse events associated with antibodies. We aimed to determine optimal elranatamab dosing regimen mitigating cytokine syndrome. Safety, pharmacokinetics, and exposure–response were analyzed across four clinical studies (MagnetisMM-1, MagnetisMM-2, MagnetisMM-3, MagnetisMM-9). Different priming regimens evaluated these included...
Antimicrobial resistance is a global threat. As "proof-of-concept," we employed system-based approach to identify patient, bacterial, and drug variables contributing mortality in patients with carbapenem-resistant Klebsiella pneumoniae (CRKp) bloodstream infections exposed colistin (COL) ceftazidime-avibactam (CAZ/AVI) as mono- or combination therapies. Patients (n = 49) CRKp isolates 22) were part of the Consortium on Resistance Against Carbapenems other Enterobacteriaceae (CRACKLE-1),...
Abstract Background A clinical drug-drug interaction (DDI) study was designed to evaluate the effect of multiple doses modafinil, a moderate CYP3A4 inducer at 400 mg QD dose, on oral dose pharmacokinetics (PK) encorafenib and its metabolite, LHY746 binimetinib AR00426032. Methods This conducted in patients with BRAF V600-mutant advanced solid tumors. Treatment modafinil given Day 15 through 21. Encorafenib 450 45 BID were administered starting 1. PK sampling from 0 8 h 14 Exposure parameters...
A knowledge gap exists for dolutegravir (DTG) pharmacokinetics and safety during the first 4 weeks of life, preventing safe effective DTG use in neonates.Population pharmacokinetic modeling simulation were used to assess newborn dosing requirements few days life as a function maternal history before delivery.DTG PK data obtained from pregnant women infants enrolled International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026S study. neonate population models separately...
Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR)-activating mutations. To evaluate effect hepatic impairment on pharmacokinetics dacomitinib, two dedicated studies were conducted to inform optimal dosing. Study 1 (NCT01571388) evaluated mild and moderate plasma pharmacokinetics, safety, tolerability after single oral dose dacomitinib 30 mg, 2 (NCT03865446) same...
Background: Minibeam radiation therapy is an experimental utilizing array of parallel submillimeter planar X-ray beams. In preclinical studies, minibeam has been shown to eradicate tumors and cause significantly less damage normal tissue compared equivalent doses delivered by conventional broadbeam therapy, where dose uniformly distributed. Methods: Expanding on prior studies that suggested increased perfusion in tumors, we a single fraction (peak dose:valley 28 Gy:2.1 Gy 100 Gy:7.5 Gy) (7...
Dolutegravir 50 mg (DTG) and rilpivirine 25 (RPV) are a newly approved 2-drug regimen for the treatment of HIV in virally suppressed patients. A 2-part study evaluated relative bioavailability food effect five experimental fixed-dose combination (FDC) tablet formulations DTG/RPV. When given with moderate- or high-fat meal, absorption both DTG RPV was increased, resulting higher exposures. As per product labelling, DTG/RPV FDC should be taken meal.
Background: Fexofenadine is a recommended in vivo probe drug for phenotyping P-glycoprotein (P-gp) and organic anion transporting polypeptide (OATP) 1B1/3 transporter activities. This study evaluated limited sampling strategy using population pharmacokinetic approach to estimate plasma fexofenadine exposure as an index of P-gp OATP Methods: In previous study, single oral dose (120 mg) was administered alone or combination with grapefruit juice, Panax ginseng , Echinacea purpurea healthy...
Fexofenadine is a probe drug used to phenotype P-glycoprotein (P-gp) and organic anion transporting polypeptide (OATP) 1B1/3 activities. This study evaluated limited sampling strategy using plasma concentrations and/or partial area under the concentration versus time curves (AUCs) estimate systemic exposure and, potentially, P-gp OATP1B1/3 activities.Plasma data were obtained from 53 healthy adult participants (22 females) four published studies. Participants administered single oral dose...