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RESUMEN Introducción: Los factores sociodemográficos y socioculturales influyen en la donación de sangre en diversos países, nuestro objetivo de estudio fue determinar cuáles son los factores que influyen en la donación de sangre en el Perú. El estudio: Se realizó un estudio observacional, transversal en personas entre 18 a 60 años a nivel nacional, se analizaron los datos mediante SPSS v.20 Hallazgos: La muestra de estudio fue de 739 personas, el 50,4% hombres; se determinó que hay buen conocimiento acerca de la donación de sangre con un porcentaje mayor al 50% de preguntas contestadas correctamente, así mismo existe una actitud positiva frente a la donación de sangre Conclusiones: Los factores socioculturales que influyen en la donación de sangre es el desconocimiento, un 40% de los participantes desconoce los requisitos básicos para ser donante de sangre, otro factor es la falsa creencia que al estar tomando medicamentos no se puede donar sangre (47%).
ABSTRACT Background: Sociodemographic and sociocultural factors influence blood donation in various countries, our objective of study was to determine what are the factors that influence blood donation in Peru. The study: An observational, crosssectional study was conducted in people between 18 and 60 years at the national level, the data were analyzed using SPSS v.20 Findings: The study sample was 739 people, 50.4% men; It was determined that there is good knowledge about blood donation with a percentage greater than 50% of questions answered correctly, likewise there is a positive attitude towards blood donation Conclusions: The sociocultural factors that influence blood donation is ignorance, 40% of the participants do not know the basic requirements to be a blood donor, another factor is the false belief. because they are taking medication, they cannot donate blood (47%).
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Nanomedicine plays an essential role in developing new therapies through novel drug delivery systems, diagnostic and imaging systems, vaccine development, antibacterial tools, and high-throughput screening. One of the most promising drug delivery systems are nanoparticles, which can be designed with various compositions, sizes, shapes, and surface modifications. These nanosystems have improved therapeutic profiles, increased bioavailability, and reduced the toxicity of the product they carry. However, the clinical translation of nanomedicines requires a thorough understanding of their properties to avoid problems with the most questioned aspect of nanosystems: safety. The particular physicochemical properties of nano-drugs lead to the need for additional safety, quality, and efficacy testing. Consequently, challenges arise during the physicochemical characterization, the production process, in vitro characterization, in vivo characterization, and the clinical stages of development of these biopharmaceuticals. The lack of a specific regulatory framework for nanoformulations has caused significant gaps in the requirements needed to be successful during their approval, especially with tests that demonstrate their safety and efficacy. Researchers face many difficulties in establishing evidence to extrapolate results from one level of development to another, for example, from an in vitro demonstration phase to an in vivo demonstration phase. Additional guidance is required to cover the particularities of this type of product, as some challenges in the regulatory framework do not allow for an accurate assessment of NPs with sufficient evidence of clinical success. This work aims to identify current regulatory issues during the implementation of nanoparticle assays and describe the major challenges that researchers have faced when exposing a new formulation. We further reflect on the current regulatory standards required for the approval of these biopharmaceuticals and the requirements demanded by the regulatory agencies. Our work will provide helpful information to improve the success of nanomedicines by compiling the challenges described in the literature that support the development of this novel encapsulation system. We propose a step-by-step approach through the different stages of the development of nanoformulations, from their design to the clinical stage, exemplifying the different challenges and the measures taken by the regulatory agencies to respond to these challenges.
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Background: Acne-induced scarring is associated with a similar burden as acne, i.e. diminished quality of life, and may be avoided if patients receive appropriate and timely acne treatment. In 2017, a four item-Acne-Scar Risk Assessment Tool (4-ASRAT) was designed by Tan et al. to categorise patients with acne into lower-risk or higher-risk for acne scarring. Its applicability outside the initial study population (France, Brazil and United States) remains to be determined. Methods: A study protocol was developed to create a systematic approach for validating and adapting 4-ASRAT to different populations, Ecuador in this case. The protocol was reviewed by 11 local and international dermatologists and pilot-tested in an Ecuadorian population using a sample of 10 participants who currently had or had had acne. Feedback from the pilot study was used to improve the study protocol. The results of the pilot study are included here, and the final study protocol is available as extended data. Results: The protocol proved to be applicable. Images taken of participants were a valuable resource for dermatological evaluation about the presence or absence of acne scars. Tangential light is necessary for this evaluation. Although dermatological assessments varied, we concluded that assessment by three local dermatologists for each participant was adequate for reaching a consensus on the presence or absence of acne scars. Conclusions: Considering the morbidity related to acne and acne scars, tools designed as prevention that alert patients about risk of developing scarring are necessary. The proposed protocol shows a feasible way of validating and adapting 4-ASRAT to different populations.
