A5082604779- Monoclonal and Polyclonal Antibodies Research
- Pharmacogenetics and Drug Metabolism
- Drug Transport and Resistance Mechanisms
- HER2/EGFR in Cancer Research
- Pharmacological Effects and Toxicity Studies
- Erythropoietin and Anemia Treatment
- Antibiotics Pharmacokinetics and Efficacy
- Hormonal Regulation and Hypertension
- Hemoglobinopathies and Related Disorders
- Analytical Methods in Pharmaceuticals
- Lung Cancer Treatments and Mutations
- Pharmaceutical studies and practices
- Renal Diseases and Glomerulopathies
- Protein purification and stability
- Gastroesophageal reflux and treatments
- Chronic Lymphocytic Leukemia Research
- Gastrointestinal motility and disorders
- Radiopharmaceutical Chemistry and Applications
- Trace Elements in Health
- Epilepsy research and treatment
- Plant-based Medicinal Research
- Diet and metabolism studies
- Biochemical effects in animals
- Vascular Malformations and Hemangiomas
- Geological and Geophysical Studies Worldwide
University of Florida
2019-2025
CDI Laboratories (United States)
2024-2025
Clinical Trial and Consulting
2024
University of Havana
2005-2022
Columbus Oncology and Hematology Associates
2019
Instituto de Nutricion e Higiene de los Alimentos
2016
The high failure rate of central nervous system (CNS) drugs is partly associated with an insufficient understanding target site exposure. Blood–brain barrier (BBB) permeability evaluation tools are needed to explore drugs’ ability access the CNS. An outstanding aspect physiologically based pharmacokinetic (PBPK) models integration knowledge on drug-specific and system-specific characteristics, allowing identification relevant factors involved in distribution. We aimed qualify a PBPK platform...
Objectives: Recombinant human erythropoietin (rHuEPO) is indicated to treat anemia in chronic kidney disease (CKD) [1]. Nevertheless, due its short half-life requires frequent administration. Pegylation an efficient method improve therapeutic proteins' pharmacokinetics (PK). However, pegylation can also affect protein biologic properties, including potency [2]. A semi-mechanistic PK/PD model was previously developed evaluate four rHuEPO (ior®EPOCIM, MIRCERA®, and PEG-EPO 32 40 kDa) rabbits...
Background/Objectives: Omeprazole is widely used for managing gastrointestinal disorders like GERD, ulcers, and H. pylori infections. However, its use in pediatrics presents challenges due to drug interactions (DDIs), metabolic variability, safety concerns. Omeprazole’s pharmacokinetics (PK), primarily influenced by CYP2C19 metabolism, affected ontogenetic changes enzyme expression, complicating dosing children. Methods: This study aimed develop validate a physiologically based...
Background: Amikacin (AMK) is used to treat gram-negative bacterial infections in intensive care unit (ICU) patients. However, its narrow therapeutic range and high interindividual variability can lead toxicity ineffectiveness. This study aimed establish a roadmap for AMK drug monitoring critically ill patients with cancer provide Bayesian estimator of bedside applicability. Methods: An observational retrospective was conducted on oncological admitted the ICU, treated as 30-min intravenous...
Regulatory agencies worldwide expect that clinical pharmacokinetic drug-drug interactions (DDIs) between an investigational new drug and other drugs should be conducted during development as part of adequate assessment the drug's safety efficacy. However, it is neither time nor cost efficient to test all possible DDI scenarios clinically. Phenytoin classified by Food Drug Administration a strong index inducer CYP3A4, moderate sensitive substrate CYP2C9. A physiologically based (PBPK)...
Carbamazepine (CBZ) is commonly prescribed for epilepsy and frequently used in polypharmacy. However, concerns arise regarding its ability to induce the metabolism of other drugs, including itself, potentially leading undertreatment co-administered drugs. Additionally, CBZ exhibits nonlinear pharmacokinetics (PK), but root causes have not been fully studied. This study aims investigate mechanisms behind CBZ’s PK induction potential on CYP3A4 CYP2C9 enzymes. To achieve this, we developed...
This study aimed (1) to develop a semimechanistic pharmacokinetic (PK) model for nimotuzumab in patients with advanced breast cancer and (2) identify demographic, biochemical, clinical predictive factors of the PK variability. Data from phase 1 were analyzed using nonlinear mixed-effects approach (NONMEM). A target-mediated disposition that included 2 open compartments, monoclonal antibody (mAb)–target binding, target mAb–target complex turnovers best described linear PK. Covariates had no...
Abstract Introduction Pharmacists are poised to be the health care professionals best suited provide medication‐related consults and services based on a patient's genetics. Despite its potential benefits, implementation of pharmacogenetic (PGx) testing into primary clinical settings has been slow among medically underserved populations. To our knowledge, this is first time that PGx‐driven recommendations have incorporated Comprehensive Medication Management (CMM) service in Hispanic...
Immunocompetent mice, Fc receptor γ-chain deficient mice (Fcer1g(-/-)), and molecular tools as F(ab')(2) bivalent fragments appear the most suitable biological models to study mechanisms of action anti-epidermal growth factor (EGFR) monoclonal antibodies (mAbs). In vivo experiments contrasting antitumor effects whole Abs their commonly involve a previous comparative pharmacokinetics study. this paper, biodistribution an anti-mouse EGFR Ab were assessed using immunocompetent mice....
Warfarin, an oral anticoagulant, has been used for decades to prevent thromboembolic events. The complex interplay between CYP2C9 and VKORC1 genotypes on warfarin PK PD properties is not fully understood in special sub-groups of patients. This study aimed externally validate a population pharmacokinetic/pharmacodynamic (PK/PD) model the effect international normalized ratio (INR) evaluate optimal dosing strategies based selected covariates Caribbean Hispanic INR, from 138 patients were...
Background: Curcumin appears to be well tolerated and effective for managing chronic inflammatory pain, but its poor oral bioavailability has been a hurdle in use as therapeutic agent. The current study was performed characterize novel co-amorphous compound based on curcumin/L-arginine 1:2 (CAC12). Methods: Stability, solubility structural characterization of the CAC12 were carried out by spectrometry techniques vitro assays, whereas antinociceptive anti-inflammatory effects evaluated CFA or...
Paliperidone was approved by the US FDA in 2006 as an extended-release (ER) tablet (Invega®) for once-daily treatment of schizophrenia. This osmotic-controlled release oral delivery system (OROS) offers advantages, such prevention plasma concentration fluctuation and reduced dosing frequency. The administration ER after a high-fat/high-calorie meal leads to increased maximum area under curve values 60% 54%, respectively. Food has various effects on gastrointestinal (GI) physiology, including...
The recombinant human erythropoietin (rHuEPO) stimulates the erythropoiesis process. Because this glycoprotein has a short half-life, it needs to be administrated two three times week. One of technics solve issue is PEGgilation.To evaluate pharmacokinetics (PK) and pharmacodynamics new branched PEGylated erythropoietins (i.e., an asymmetric 32 kDa-PEG2-rHuEPO symmetric 40 molecule) compared non-PEGylated ior®EPOCIM MIRCERA®.Serum concentrations both were measured at various time points in...
Autosomal dominant polycystic kidney disease (ADPKD) is a genetic characterized by an overexpression and mislocalization of epidermal growth factor receptor (EGFR) to the apical membranes cystic epithelial cells. Nimotuzumab humanized antibody that recognizes extracellular domain III human EGFR. The aim this study was assess pharmacokinetic behavior nimotuzumab in patients with ADPKD given as single dose. A phase I, single-center, noncontrolled open clinical conducted. Five were enrolled at...
Abstract Objectives The inter-individual variability of warfarin dosing has been linked to genetic polymorphisms. This study was aimed at performing genotype-driven pharmacokinetic (PK) simulations predict levels in Puerto Ricans. Methods Analysis each individual dataset performed by one-compartmental modeling using WinNonlin®v6.4. k e given a cytochrome P450 2C9 ( CYP2C9 ) genotype ranged from 0.0189 0.0075 h −1 . K and V d parameters were taken literature. Data 128 subjects divided into...
Abstract Objectives The inter-individual variability of warfarin dosing has been linked to genetic polymorphisms. This study was aimed at performing genotype-driven pharmacokinetic (PK) simulations predict levels in Puerto Ricans. Methods Analysis each individual dataset performed by one-compartmental modeling using WinNonlin®v6.4. k e given a cytochrome P450 2C9 ( CYP2C9 ) genotype ranged from 0.0189 0.0075 h −1 . K and V d parameters were taken literature. Data 128 subjects divided into...