A5074716018- Computational Drug Discovery Methods
- Statistical Methods in Clinical Trials
- Drug Solubulity and Delivery Systems
- Biosimilars and Bioanalytical Methods
- Optimal Experimental Design Methods
- Antibiotics Pharmacokinetics and Efficacy
- Drug Transport and Resistance Mechanisms
- Pneumonia and Respiratory Infections
- Pulmonary Hypertension Research and Treatments
- Health Systems, Economic Evaluations, Quality of Life
- Pharmacogenetics and Drug Metabolism
- Sinusitis and nasal conditions
- Forensic Toxicology and Drug Analysis
- Analytical Methods in Pharmaceuticals
- Eicosanoids and Hypertension Pharmacology
- Protein purification and stability
- Aquaculture Nutrition and Growth
- Toxin Mechanisms and Immunotoxins
- Gene expression and cancer classification
- Synthesis and Catalytic Reactions
- Drug-Induced Hepatotoxicity and Protection
- Fungal Plant Pathogen Control
- Dental Research and COVID-19
- Pharmaceutical and Antibiotic Environmental Impacts
- Per- and polyfluoroalkyl substances research
University of Lisbon
2013-2024
Universidade Estadual do Oeste do Paraná
2024
Meropenem is a carbapenem antibiotic commonly used in critically ill patients to treat severe infections. The available pharmacokinetic (PK) data has been mostly obtained from healthy volunteers as well clinical studies addressing selected populations, often excluding the elderly and also with renal failure. Our aim was study PK of meropenem broader population septic patients. We characterized 15 during first 36 hrs therapy. Aditionally, whenever possible, we collected second set late plasma...
The beneficial health effects of Chlorella vulgaris have been associated with the presence several nutrients and antioxidants, including carotenoids. However, in vivo bioavailability is still poorly evaluated. In this work, a human intervention study was conducted 11 healthy men to evaluate carotenoids within 3 days after intake single dose (6 g) dried marine containing lutein (7.08 mg), β-carotene (1.88 mg) zeaxanthin (1.47 mg). Subjects were instructed follow low carotenoid diet during...
In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when 90% confidence interval ratio of population geometric means test and reference products AUC, in some cases Cmax, falls within acceptance range 90.00% to 111.11%. However, meeting this requirement results an increased difficulty demonstrating BE a need clinical trials with larger subject sample sizes, especially medium-to-high variability drugs. To address challenge, scaled...
Abstract Objectives The in vitro synergy of the amoxicillin/clavulanic acid combination has not always translated vivo into clinical superiority compared with amoxicillin alone. Specifically, conflicting reports have disputed treatment both acute otitis media and sinusitis. One possible reason for this may to do inadequate target tissue pharmacokinetics. To explore possibility sinuses, we undertook present investigation. Study Design A randomized, open, single‐dose, sinus pharmacokinetic...
Moxifloxacin is a new fluoroquinolone antimicrobial approved for the treatment of acute bacterial rhinosinusitis. In order to assess its distribution pattern into paranasal sinuses, and specifically evaluate how histopathologic changes associated with chronic inflammation affect tissue penetration, we conducted present investigation, randomized, open-label, single dose, sinus-tissue pharmacokinetic study oral moxifloxacin. Twenty adult subjects, selected surgery because recalcitrant...
Abstract Aminocarbonyloxymethyl ester prodrugs are known to undergo rearrangement in aqueous solutions form the corresponding N ‐acylamine side product via an O → intramolecular acyl transfer from carbamate conjugate base. Novel aminocarbonyloxymethyl esters of diclofenac and flufenamic acid containing amino amide carriers were synthesized evaluated as potential displaying less ability rearrangement. These compounds prepared reasonable yield by a four‐step synthetic method that uses...
Pilot bioavailability/bioequivalence (BA/BE) studies are usually conducted and analysed similarly to pivotal studies. Their analysis interpretation of results rely on the application average bioequivalence approach. However, due small study size, pilot inarguably more sensitive variability. The aim this work is propose alternative approaches methodology, in a way overcome reduce uncertainty conclusions these potential test formulations. Several scenarios BA/BE crossover were simulated...
Abstract Aims Dopamine beta‐hydroxylase (DβH) inhibitors, like zamicastat, hold promise for treating pulmonary arterial hypertension. This study aimed to validate the mechanism of action zamicastat by studying its effect on overdrive sympathetic nervous system (SNS). Methods A single‐centre, prospective, double‐blind, randomized, placebo‐controlled, crossover evaluated 400 mg in 22 healthy male subjects. Cold pressor test (CPT) was performed at screening and each treatment period Days −1 10....
The potential of a physiologically-based pharmacokinetic (PBPK) model to predict oral amoxicillin bioavailability, by considering the physiological changes after "Roux-en-Y gastric bypass" (RYGB) surgery in bariatric patients, was evaluated. A middle-out approach for parameter estimations undertaken using vitro, situ, and vivo data. observed versus predicted plasma concentrations sensitivity simulated parameters AUC0-inf Cmax (AMX) were used confirm reliability estimation. considers that...
The current regulatory criterion for bioequivalence of narrow therapeutic index (NTI) drugs in the European Union requires that 90% confidence interval ratio population geometric means test product compared with reference area under plasma concentration-time curve (AUC), and certain cases maximum drug concentration (Cmax ), to be included within tighter acceptance range 90.00-111.11%. As a consequence, sponsors need recruit higher number subjects demonstrate this may seen as increasing...
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 18 subjects usually enrolled, although, in principle, a sample size is not formally calculated. previous work, authors recommended use of an alternative approach average bioequivalence methodology evaluate pilot studies’ data, using geometric mean (Gmean) ƒ2 factor with cut off 35, which has shown appropriate method assess potential for...
Background: When companies are uncertain about the potential of a new formulation to be bioequivalent Reference product, it is common practice carry out downsized pilot studies as gatekeeping in vivo strategy decide whether move forward or not with full-size pivotal study. However, due small study size, these inarguably more sensitive variability. Objectives: To address and mitigate uncertainty conclusions concerning maximum observed concentration (Cmax), f2 factor was proposed an...