Nuno Silva
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View article: Nortriptyline-targeted siRNA-loaded liposomes: Design, affinity, biodistribution, and bioactivity in a murine Herpes Simplex Virus 1 corneal infection model
Nortriptyline-targeted siRNA-loaded liposomes: Design, affinity, biodistribution, and bioactivity in a murine Herpes Simplex Virus 1 corneal infection model Open
Herpes simplex virus type 1 (HSV1) establishes latency in the trigeminal ganglia and reactivates to cause recurrent infections and severe complications, including herpes simplex keratitis (HSK), the leading cause of infectious corneal blin…
View article: Analysis of drugs of abuse and contaminants in individuals under drug surveillance programs: A study in hair samples
Analysis of drugs of abuse and contaminants in individuals under drug surveillance programs: A study in hair samples Open
In this study, over 900 hair samples from individuals using drugs of abuse in São Paulo and Rio Grande do Sul, Brazil were analysed for classical drugs and new psychoactive substances (NPS) in hair samples. Liquid chromatography-tandem mas…
View article: Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products
Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products Open
Background: When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to…
View article: A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union
A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union Open
In the European Union, bioequivalence (BE) for narrow therapeutic index (NTI) drugs is currently demonstrated when the 90% confidence interval for the ratio of the population geometric means of the test and reference products for AUC, and …
View article: Effect of zamicastat on blood pressure and heart rate response to cold pressor test: a double-blind, randomised, placebo-controlled study in healthy subjects
Effect of zamicastat on blood pressure and heart rate response to cold pressor test: a double-blind, randomised, placebo-controlled study in healthy subjects Open
Aim: Inhibitors of dopamine-β-hydroxylase (DβH), such as zamicastat, emerged as promising drugs for pulmonary arterial hypertension (PAH). This study intended to validate the mechanism of action of zamicastat by studying its effect on the …
View article: Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method
Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method Open
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not fo…
View article: Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies
Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies Open
Pilot bioavailability/bioequivalence (BA/BE) studies are usually conducted and analysed similarly to pivotal studies. Their analysis and interpretation of results usually rely on the application of the average bioequivalence approach. Howe…
View article: A Single Dose of Marine Chlorella vulgaris Increases Plasma Concentrations of Lutein, β-Carotene and Zeaxanthin in Healthy Male Volunteers
A Single Dose of Marine Chlorella vulgaris Increases Plasma Concentrations of Lutein, β-Carotene and Zeaxanthin in Healthy Male Volunteers Open
The beneficial health effects of Chlorella vulgaris have been associated with the presence of several nutrients and antioxidants, including carotenoids. However, the in vivo bioavailability of Chlorella is still poorly evaluated. In this w…