Representaciones sociales de bioética en epidemiólogos en formación

Introducción: La formación en bioética de los epidemiólogos repercute favorablemente en la salud de las comunidades, contribuye a la toma de decisiones éticas y ayuda a promover resultados sanitarios equitativos para todas las poblaciones. Objetivo: Identificar las representaciones sociales (RS) de bioética en estudiantes de la Especialización en Epidemiología de una universidad en Pereira, Risaralda, Colombia. Método: Estudio cualitativo desde el enfoque teórico de la antropología cognitiva mediante el análisis procesual, prototípico y estructural de las representaciones sociales, a través de las técnicas asociativas de listado libre y cuestionario de comparación de pares, para consolidar el contenido, la organización y representación gráfica de las RS de 17 estudiantes de especialización en Epidemiología. Resultados: Para los participantes, las RS sobre bioética gira en torno a la ética por la vida y respeto por los derechos humanos en su núcleo central, los aspectos que establecen los elementos periféricos de la representación se constituyen en principios, moral, equidad, respeto y normas. Discusión: Los resultados aquí presentados se discuten a la luz de los avances conceptuales de la ética aplicada, la bioética principialista y la bioética global, en perspectiva de derechos por el respeto a la vida. Conclusiones: las RS de bioética en los epidemiólogos en formación es comprendida de manera amplia como una rama de la ética desde una perspectiva de derechos y de respeto a la vida.

Introduction: Bioethics education for epidemiologists has a favorable impact on the health of communities, contributes to ethical decision making and helps promote equitable health outcomes for all populations. Objective: To identify the social representations (SR) of bioethics in students of the epidemiology specialization of a university in Pereira, Risaralda, Colombia. Method: qualitative study from the theoretical approach of cognitive anthropology by means of processual, prototypical and structural analysis of Social Representations through the associative techniques of free listing and peer comparison questionnaire, to consolidate the content, organization and graphic representation of the SRs of 17 students of the specialization in epidemiology. Results: For the participants, SR on Bioethics revolves around ethics for life and respect for human rights in its central core; the aspects that establish the peripheral elements of the representation are constituted by principles, morals, equity, respect and norms. Discussion: The results presented here are discussed in the light of conceptual advances in applied ethics, principlist bioethics and global bioethics in the perspective of rights for the respect of life. Conclusions: SR of bioethics in epidemiologists in training is broadly understood as a branch of ethics from a perspective of rights and respect for life.

Hurricanes affect diversification among individual life courses of a primate population.

Extreme climatic events may influence individual-level variability in phenotypes, survival and reproduction, and thereby drive the pace of evolution. Climate models predict increases in the frequency of intense hurricanes, but no study has measured their impact on individual life courses within animal populations. We used 45 years of demographic data of rhesus macaques to quantify the influence of major hurricanes on reproductive life courses using multiple metrics of dynamic heterogeneity accounting for life course variability and life-history trait variances. To reduce intraspecific competition, individuals may explore new reproductive stages during years of major hurricanes, resulting in higher temporal variation in reproductive trajectories. Alternatively, individuals may opt for a single optimal life-history strategy due to trade-offs between survival and reproduction. Our results show that heterogeneity in reproductive life courses increased by 4% during years of major hurricanes, despite a 2% reduction in the asymptotic growth rate due to an average decrease in mean fertility and survival by that is, shortened life courses and reduced reproductive output. In agreement with this, the population is expected to achieve stable population dynamics faster after being perturbed by a hurricane ( ρ = 1.512 ; 95% CI: 1.488, 1.538), relative to ordinary years ρ = 1.482 ; 1.475 , 1.490 . Our work suggests that natural disasters force individuals into new demographic roles to potentially reduce competition during unfavourable environments where mean reproduction and survival are compromised. Variance in lifetime reproductive success and longevity are differently affected by hurricanes, and such variability is mostly driven by survival.

The U.S. Travel Health Pharmacists' Role in a Post-COVID-19 Pandemic Era.

Background: Many countries have enforced strict regulations on travel since the emergence of the SARS-CoV-2 (COVID-19) pandemic in December 2019. However, with the development of several vaccines and tests to help identify it, international travel has mostly resumed in the United States (US). Community pharmacists have long been highly accessible to the public and are capable of providing travel health services and are in an optimal position to provide COVID-19 patient care services to those who are now starting to travel again. Objectives: (1) To discuss how the COVID-19 pandemic has changed the practice of travel health and pharmacist provided travel health services in the US and (2) to discuss the incorporation COVID-19 prevention measures, as well as telehealth and other technologies, into travel health care services. Methods: A literature review was undertaken utilizing the following search engines and internet websites: PubMed, Google Scholar, Centers for Disease Control Prevention (CDC), World Health Organization (WHO), and the United States Department of Health and Human Services to identify published articles on pharmacist and pharmacy-based travel health services and patient care in the US during the COVID-19 pandemic. Results: The COVID-19 pandemic has changed many country's entry requirements which may now include COVID-19 vaccination, testing, and/or masking requirements in country. Telehealth and other technological advancements may further aid the practice of travel health by increasing patient access to care. Conclusions: Community pharmacists should consider incorporating COVID-19 vaccination and testing services in their travel health practices in order to meet country-specific COVID-19 entry requirements. Further, pharmacists should consider utilizing telehealth and other technologies to increase access to care while further limiting the potential spread and impact of COVID-19.

Factores de mal pronóstico en pacientes geriátricos con lesión medular traumática

Introducción: El trauma raquimedular es una afección devastadora que cursa con alteraciones sensitivas, motoras y autonómicas, sin embargo, la sobrevida depende de factores pronósticos descritos en la literatura como son: la edad, las comorbilidades propias del individuo, la severidad del trauma inicial, el nivel y tipo de lesión ente otras. Objetivo: Evaluar los factores clínicos-epidemiológicos que afectan la evolución en los enfermos geriátricos portadores de lesión medular cervical traumática. Métodos: La investigación se realizó en un periodo de tres años, en el servicio de Neurocirugía y constó con varias etapas: se dedicaron dos años a la selección de los enfermos: enero 2018 a julio 2020, se completó el tiempo destinado al estudio con el seguimiento por consulta hasta los seis meses. Resultados: Predominó el grupo de 60 a 69 años del sexo masculino con un 56,6 % con dominio de los grupos de severidad A y B de la escala de ASIA. Los factores de mal pronóstico en el daño medular fueron los cambios degenerativos del raquis, el nivel de lesión baja y el alto índice de complicaciones entre otros. Como resultado, el grado de dependencia social en el grupo fue moderado o severo y los fallecidos fueron el 46,6 % de los casos tratados. Conclusiones: El trauma raquimedular cervical representa un evento complejo y multifactorial en el que influyen las comorbilidades, las características del evento traumático y el desarrollo tecnológico del centro. La valoración adecuada de cada uno de ellos puede mejorar los resultados para los lesionados de más de 60 años.

Introduction: Spinal cord trauma is a devastating condition that causes sensory, motor and autonomic alterations, however, survival depends on prognostic factors described in the literature such as: comorbidities of the individual, the severity of the initial trauma, the level of the injury, among others. Objective: To evaluate the clinical and epidemiological factors that overshadow the evolution in geriatric patients with traumatic cervical spinal cord injury. Methods: The research was carried out over a period of three years, in the Neurosurgery service and consisted of several stages: two years were dedicated to the selection of patients: January 2018 to July 2020, the time allocated to the study was completed with follow-up by consultation up to six months. Results: The group of 60 to 69 years of male sex prevailed with 56.6% with domain of severity groups A and B of the ASIA scale. Poor prognostic factors in spinal cord injury were degenerative changes of the spine, low injury level and high rate of complications among others. As a result, the degree of social dependence in the group was moderate or severe and the deceased were 46,6% of the cases treated. Conclusions: Cervical spinal cord trauma represents a complex and multifactorial event that is influenced by comorbidities, the characteristics of the traumatic event and the technological development of the center. Proper assessment of each of them can improve outcomes for those injured over 60 years of age.

Essential oil composition and cytotoxic activity in twospecies ofthe plant genus Vismia (Hypericaceae) from the Venezuelan Andes

Introduction: The Vismia genus belongs to the Hypericaceae family and comprises around 57 species of which 17 have been located in Venezuela. Previous investigations have been carried out in extracts as well as pure isolated compounds, revealing antimicrobial, antioxidant and anti-HIV, among other, biological activities. Objective: This investigation aims to determine the cytotoxic activity of essential oils from leaves of Vismia baccifera Triana & Planch (VBJ and VBV) and Vismia macrophylla Kunth (VM) collected in three different locations of the Venezuelan Andean region. Methods: Essential oils obtained by hydrodistillation were analyzed using gas chromatography-mass spectrometry (GC-MS) and their cytotoxic activity was analyzed following the MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) assay. Human tumor cell lines from SKBr3, MCF-7 and PANC-1, two breast carcinomas and one pancreatic adenocarcinoma of ductal type, were tested with the oil samples and human dermis fibroblasts were used as non-tumor cells. Results: β-caryophyllene and trans-caryophyllene were present as major components in VBJ and VBV, respectively, while γ-bisabolene was the main component in the VM sample. Anticancer activity was observed on V. baccifera essential oil against SKBr3, MCF-7 and PANC-1. The selectivity index showed that VBV is highly selective against the SKBr3 cell line and has no activity against non-tumor cells. Conclusions: These results are considered a contribution to natural products research and may provide supportive data for future studies on cancer.

Introducción: El género Vismia pertenece a la familia Hypericaceae y comprende alrededor de 57 especies de las cuales 17 han sido ubicadas en Venezuela. Se han realizado investigaciones previas tanto en extractos como en compuestos puros aislados revelando actividad antimicrobiana, antioxidante y anti-VIH, entre otras actividades biológicas. Objetivo: El propósito de esta investigación es determinar la actividad citotóxica de los aceites esenciales de las hojas de Vismia baccifera Triana & Planch (VBJ y VBV) y Vismia macrophylla Kunth (VM) recolectadas en tres localidades de la región andina venezolana. Métodos: Aceites esenciales obtenidos por hidrodestilación fueron analizados por cromatografía de gases-espectrometría de masas y su actividad citotóxica fue analizada siguiendo el método MTT (bromuro de 3-[4,5-dimetiltiazol-2-il]-2,5-difeniltetrazolio). Los aceites esenciales fueron ensayados frente a células tumorales humanas SKBr3, MCF-7 y PANC-1, dos carcinomas de mama y un adenocarcinoma pancreático del tipo ductal, usando cultivos primarios de fibroblastos de dermis humana como células no tumorales. Resultados: β-cariofileno y trans-cariofileno estuvieron presentes como compuestos mayoritarios en VBJ y VBV, respectivamente, mientras que γ-bisaboleno fue el componente principal en la muestra VM. El aceite esencial de V. baccifera mostró actividad anticancerígena frente a SKBr3, MCF-7 y PANC-1. El índice de selectividad reveló que VBV es altamente selectivo frente a la línea celular SKBr3 y no presenta actividad contra las células no tumorales. Conclusiones: Estos resultados se consideran una contribución a la investigación de los productos naturales y los datos pueden ser de utilidad en futuras investigaciones sobre el cáncer.

COVID-19 y sus imaginarios socioculturales en Latinoamérica: una herramienta para la salud pública / COVID-19 and its socio-cultural imagery in Latin America: a tool for public health

RESUMEN Objetivo Identificar el contenido y organización de las representaciones sociales que tiene la población urbana de tres ciudades de América Latina sobre el COVID-19. Materiales y Métodos Estudio cualitativo hecho desde la antropología cognitiva a través del análisis estructural de las representaciones sociales. Se utilizaron técnicas de listados libres y comparación de pares de febrero a abril de 2020 en Pereira (Colombia), en la zona metropolitana de Guadalajara (México) y en León (también en México). Participaron 97 personas de ambos sexos (97 en la primera fase y 71 en la segunda), mayores de edad y que su ocupación o profesión no tuvieran relación con el área de salud; se realizó muestreo no probabilístico-propositivo. Resultados El imaginario sociocultural está asociado con términos como contagio y pandemia, con énfasis en los términos relacionados con la prevención de la enfermedad. Conclusiones Los saberes de la población sobre el COVID-19 privilegian aspectos clínicos y epidemiológicos, así como las medidas de contención y mitigación.

ABSTRACT Objective Identify the content and organization of social representations (SR) against COVID-19 in urban population of three cities in Latin America, 2020. Materials and Methods Qualitative study from cognitive anthropology through the structural analysis of SR. Free listing and pair comparison techniques were used from February-April 2020, in Pereira (Colombia), Guadalajara Metropolitan Area (ZMG)-(Mexico), León (Mexico). 97 participants were included in the first phase and 71 in the second phase, of both sexes, of legal age, whose occupation and profession had no relation to the health area; non-probability-purposeful sampling was performed. Results The socio-cultural imaginary is associated with terms such as contagion, pandemic, but highlighting the terms related to disease prevention. Conclusions The knowledge of the population about COVID-19 privileges clinical and epidemiological aspects, as well as containment and mitigation measures.

Representaciones sociales del cáncer de mama: una comparación de mujeres con diagnóstico reciente y mujeres sanas / Social Representations of Breast Cancer: a Comparison of Women with Recent Diagnosis and Healthy Women

Resumen Identificar las representaciones sociales (RS) del cáncer de mama en mujeres con diagnóstico y mujeres sanas o libres de enfermedad (MLE), Guadalajara-Jalisco, 2016. Se aplicó la técnica asociativa de listados libres y cuestionario de pares a 40 mujeres; para conocer la estructura de las RS se hizo análisis de contenido temático y estructural de la RS.Los hallazgos muestran que las mujeres diagnosticadas tienen mayor conciencia sobre la importancia de prevención y detección oportuna. MLE otorgaron mayor importancia a aspectos negativos como miedo y muerte. La RS sobre la enfermedad se construye a través de las vivencias, ya sea propia con el diagnóstico o a través de experiencias de una persona cercana o conocimientos sociales.

Abstract The objective of the study was to identify the social representations (SR) of breast cancer in diagnosed women and healthy or disease-free women (MLE), Guadalajara-Jalisco, 2016. The associative technique of free listing and peer questionnaire was applied to 40 women. In order to know the structure of SR, a thematic and structural content analysis of SR was carried out. The findings show that diagnosed women are more aware of the importance of prevention and timely detection. MLE gave greater importance to negative aspects such as fear and death. The SR on the disease is built through experiences, either one's own with the diagnosis, through the experiences of a close person, or through social knowledge.

Factores de riesgo reproductivo preconcepcional en mujeres de edad fértil del área Este de Guantánamo, 2020 / Preconception reproductive risk factors in women of childbearing age in the East area of Guantanamo in 2020

Introducción: el riesgo reproductivo preconcepcional es la probabilidad que tiene una fémina no gestante de sufrir daño -ella o su producto-, si se involucra en el proceso reproductivo. Objetivo: identificar los factores de riesgo reproductivo preconcepcional en las mujeres en edad fértil del Consultorio Médico de la Familia No. 33, perteneciente al Policlínico Universitario ¨4 de Abril¨, área Este del municipio Guantánamo, en el periodo septiembre de 2019 a marzo de 2020. Método: se realizó un estudio descriptivo con corte transversal, en mujeres en edad fértil (15 a 49 años), pertenecientes a 20 familias del consultorio antes mencionado. El universo estuvo constituido por las 65 mujeres en edad fértil de esas familias. Las variables estudiadas fueron los factores de riesgo socio-laboral-ambiental, riesgos según antecedentes obstétricos desfavorables y riesgos por enfermedades crónicas no transmisibles. Resultados: predominaron las madres solteras, edad menor de 20 años y mayor de 30 años, que representaron el 50,8; 44, 6 y 32,3 %, respectivamente. Los antecedentes obstétricos que más se identificaron fueron el aborto (52,3 %) y la multiparidad (47,7 %). La hipertensión arterial fue la enfermedad crónica no transmisible más encontrada (56,9 %). Conclusiones: todas las mujeres presentan algún tipo de riesgo, lo que coloca a la madre y a su hijo en una situación de vulnerabilidad durante el embarazo

Introduction: preconception reproductive risk is the likelihood that a non-pregnant female will be harmed - herself or her gestation - if she becomes involved in the reproductive process. Objective: to identify the preconception reproductive risk factors in women of childbearing age in the Family Medical Office No. 33, belonging to the ¨4 de Abril¨ University Polyclinic, located in the eastern area of the municipality of Guantánamo, in the period time September 2019 to March 2020. Method: a cross-sectional, descriptive study was conducted on women of childbearing age (15-49 years) from 20 families in the Family Medical Office mentioned before. The universe was made up of the 65 women of childbearing age in those families. The variables studied were social and environmental risk factors, risks according to unfavorable obstetric history and risks for chronic non-communicable diseases. Results: single mothers under 20 and over 30 years old predominated, which represented 50.8%, 44, 6% and 32.3 % respectively. The most common obstetric history identified was abortion (52.3%) and multiparity (47.7%). High blood pressure was the most common chronic non-communicable disease found (56.9%). Conclusions: all women present some kind of risk, aspect that places the mother and child in a vulnerable situation during pregnancy

[COVID-19 and its socio-cultural imagery in Latin America: a tool for public health]. / COVID-19 y sus imaginarios socioculturales en Latinoamérica: una herramienta para la salud pública.

OBJECTIVE: Identify the content and organization of social representations (SR) against COVID-19 in urban population of three cities in Latin America, 2020. MATERIALS AND METHODS: Qualitative study from cognitive anthropology through the structural analysis of SR. Free listing and pair comparison techniques were used from February-April 2020, in Pereira (Colombia), Guadalajara Metropolitan Area (ZMG)-(Mexico), León (Mexico). 97 participants were included in the first phase and 71 in the second phase, of both sexes, of legal age, whose occupation and profession had no relation to the health area; non-probability-purposeful sampling was performed. RESULTS: The socio-cultural imaginary is associated with terms such as contagion, pandemic, but highlighting the terms related to disease prevention. CONCLUSIONS: The knowledge of the population about COVID-19 privileges clinical and epidemiological aspects, as well as containment and mitigation measures.

OBJETIVO: Identificar el contenido y organización de las representaciones sociales que tiene la población urbana de tres ciudades de América Latina sobre el COVID-19. MATERIALES Y MÉTODOS: Estudio cualitativo hecho desde la antropología cognitiva a través del análisis estructural de las representaciones sociales. Se utilizaron técnicas de listados libres y comparación de pares de febrero a abril de 2020 en Pereira (Colombia), en la zona metropolitana de Guadalajara (México) y en León (también en México). Participaron 97 personas de ambos sexos (97 en la primera fase y 71 en la segunda), mayores de edad y que su ocupación o profesión no tuvieran relación con el área de salud; se realizó muestreo no probabilístico-propositivo. RESULTADOS: El imaginario sociocultural está asociado con términos como contagio y pandemia, con énfasis en los términos relacionados con la prevención de la enfermedad. CONCLUSIONES: Los saberes de la población sobre el COVID-19 privilegian aspectos clínicos y epidemiológicos, así como las medidas de contención y mitigación.

Sobre la importancia de la certificación internacional para los anilladores de aves en Perú / About international certification importance for Bird Banders in Peru

La certificación como anillador de aves consiste en validar el nivel de conocimiento y experiencia de personas frente a un estándar consolidado de trabajo en el ejercicio de la captura, anillado, manejo, y liberación de aves, con el fin de promover la seguridad del ave, la seguridad del anillador y la calidad de los datos colectados. El Consejo Norteamericano de Anillado (NABC) es una organización sin fines de lucro, engloba a diversas organizaciones de investigación, conservación y gestión de la avifauna en Norteamérica. Continuando con su principal misión de promover prácticas responsables de la técnica del anillado de aves bajo criterios estandarizados y éticos, en un trabajo conjunto con el Centro de Ornitología y Biodiversidad (CORBIDI) y otras instituciones afines, entre el 2017 y el 2018 se han desarrollado las tres primeras sesiones de certificación NABC en el Perú. El presente trabajo intenta responder algunas de las preguntas más frecuentes relacionados con estas sesiones de certificación, así como los esfuerzos del anillado de aves promovidos por el Programa de Anillamiento CORBIDI (PAC).

Certification as bird bander implies to validate the level of knowledge and experience of people with regard to a consolidated standard of work in the exercise of capture, banding, handling, and release of birds, in order to promote the safety of the bird, the security of the bander and the quality of the data collected. The North American Banding Council (NABC) is a non-profit organization that includes diverse organizations of research, conservation and management of North American avifauna. Continuing with its mission to promote responsible bird-banding practices under standardized and ethical criteria, in a joint effort with the Centro de Ornitologia y Biodiversidad (CORBIDI) and other related institutions, the first three NABC certification sessions were recently held in Peru. This work tries to answer some of the most frequent questions related to these certification events and the bird banding efforts promoted by the Programa de Anillamiento CORBIDI (PAC).

Marmots do not consistently use their left eye to respond to an approaching threat but those that did fled sooner.

In many vertebrates, the brain's right hemisphere which is connected to the left visual field specializes in the processing of information about threats while the left hemisphere which is connected to the right visual field specializes in the processing of information about conspecifics. This is referred to as hemispheric lateralization. But individuals that are too predictable in their response to predators could have reduced survival and we may expect selection for somewhat unpredictable responses. We studied hemispheric lateralization in yellow-bellied marmots Marmota flaviventer, a social rodent that falls prey to a variety of terrestrial and aerial predators. We first asked if they have lateralized responses to a predatory threat. We then asked if the eye that they used to assess risk influenced their perceptions of risk. We recorded the direction marmots were initially looking and then walked toward them until they fled. We recorded the distance that they responded to our experimental approach by looking, the eye with which they looked at us, and the distance at which they fled (i.e., flight initiation distance; FID). We found that marmots had no eye preference with which they looked at an approaching threat. Furthermore, the population was not comprised of individuals that responded in consistent ways. However, we found that marmots that looked at the approaching person with their left eye had larger FIDs suggesting that risk assessment was influenced by the eye used to monitor the threat. These findings are consistent with selection to make prey less predictable for their predators, despite underlying lateralization.

Mycobacterium "habana" TMC 5135 as a vaccine candidate against tuberculosis: In vitro studies.

Background: Tuberculosis (TB) is one of the biggest problems of global health, at present. Bacillus-Calmette-Guérin is the only vaccine available against this disease. It protects only against the severe forms of TB in the childhood, which is a challenge in the search of new vaccine candidates. Taking into account the protective history of Mycobacterium "habana" against experimental TB, we proposed to provide the elements that support the use of M. "habana" TMC 5135 as a vaccine candidate against TB by infection studies in murine macrophages cell cultures. Methods: The production of microbicidal compounds dependent on oxygen metabolism as nitric oxide and hydrogen peroxide by murine peritoneal macrophages was detected. The invasive and toxigenic capacity of M. "habana" to infect this cell type was also evaluated through the quantification of intracellular alive bacillus and 3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide assay, respectively. Results: The results suggest that M. "habana" TMC 5135 is able to persist into peritoneal macrophages, to resist the effectors mechanisms of respiratory burst, and to keep the viability of the target cell. The demonstration of these effector mechanisms and the survival capacity of M. "habana" in this niche are relevant aspects of this research assuring the continuity of this candidate to next phases of preclinical development. Conclusion: The present investigation contributes to the characterization of the infection by this mycobacteria in its main target cells of innate immunity and it suggest future investigations to evaluate the activation of effector mechanisms of the innate immunity against this candidate.

Potential adverse cardiac remodelling in highly trained athletes: still unknown clinical significance.

Moderate endurance exercise has long been considered an essential element to maintain cardiovascular health, and sedentary behaviour in the general population has been related to a significant increase in all-causes of mortality, cardiovascular disease mortality and cardiovascular disease incidence. However, a growing group of people performs an intense exercise that leads to multiple heart adaptive changes that are collectively called "athlete's heart". In this review, we discussed the evidence of cardiac remodelling process secondary to repetitive and strenuous exercise in some predisposed athletes that produces intense and probably deleterious changes in cardiac morphology and function with no clear clinical significance in long-term follow-up. Moreover, we also discussed the individual biological response to exercise assessed by myocardial damage, inflammation, oxidative stress, fibrosis and ventricular hypertrophy biomarkers showing different intensities with equivalent exertion.

Analysis of the complete organellar genomes of the rockweed Fucus spiralis (Fucaceae, Phaeophyceae) supports its infraspecific recognition as Fucus vesiculosus var. spiralis.

Fucus spiralis L. is a broadly distributed monoecious intertidal seaweed. The specific status of F. spiralis however is debatable. Here, we contribute to the bioinformatics and systematics of F. spiralis by analysing the complete mitochondrial and plastid genomes of a specimen from California, U.S.A. The F. spiralis mitogenome is 36,396 base pairs (bp) in length and contains 67 genes, and the plastid genome is 125,066 bp in length and contains 171 genes. The F. spiralis genomes are 99.7% and 99.8% similar in nucleotide sequence to F. vesiculosus, and support the revised classification of F. spiralis to Fucus vesiculosus var. spiralis.

Characterization and comparability of biosimilars: a filgrastim case of study and regulatory perspectives for Latin America

Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.

Optimization of a recombinant human growth hormone purification process using quality by design.

This work describes a strategy to optimize a downstream processing of a recombinant human growth hormone (rhGH) by incorporating a quality by design approach toward meeting higher quality specifications. The optimized process minimized the presence of impurities and degradation by-products during manufacturing by the establishment of in-process controls. Capillary zone electrophoresis, reverse phase, and size-exclusion chromatographies were used as analytical techniques to establish new critical process parameters for the solubilization, capture, and intermediate purification steps aiming to maintain rhGH quality by complying with pharmacopeial specifications. The results indicated that the implemented improvements in the process allowed the optimization of the specific recovery and purification of rhGH without compromising its quality. In addition, this optimization facilitated the stringent removal of the remaining impurities in further polishing stages, as demonstrated by the analysis of the obtained active pharmaceutical ingredient.

Physicochemical and biological characterization of a biosimilar trastuzumab.

According to the World Health Organization, the incidence of malignant neoplasms and endocrine, blood, and immune disorders will increase in the upcoming decades along with the demand of affordable treatments. In response to this need, the development of biosimilar drugs is increasing worldwide. The approval of biosimilars relies on the compliance with international guidelines, starting with the demonstration of similarity in their physicochemical and functional properties against the reference product. Subsequent clinical studies are performed to demonstrate similar pharmacological behavior and to diminish the uncertainty related to their safety and efficacy. Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using a hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact on its pharmacokinetics, pharmacodynamics, and immunogenicity. Our results showed that the high degree of similarity in the physicochemical attributes of the biosimilar trastuzumab with respect to the reference product resulted in comparable biological activity, demonstrating that a controlled process is able to provide consistently the expected product. These results also constitute the basis for the design of subsequent delimited pharmacological studies, as they diminish the uncertainty of exhibiting different profiles.

Effect of pH and oxygen on biofilm formation in acute otitis media associated NTHi clinical isolates.

OBJECTIVES/HYPOTHESIS: Biofilms occur in animal models of acute otitis media (AOM) and in children with recurrent AOM (rAOM) and chronic otitis media with effusion (OME). We therefore studied the ability of nontypeable Haemophilus influenzae (NTHi) strains from children to form biofilms in vitro under conditions we presumed occurred in the middle ear during AOM, rAOM, and OME. STUDY DESIGN: Evaluate NTHi isolates for biofilm formation across a pH range under aerobic, microaerophilic, and anaerobic conditions. METHODS: Using a crystal violet biofilm assay we studied 12 NTHi pediatric clinical isolates to investigate biofilm formation over a pH range of 4.5 to 10 under aerobic, microaerophilic, and anaerobic conditions. RESULTS: Our findings included: 1) not all clinical NTHi strains form biofilms (75% did); 2) the pH of middle ear fluid collected from AOM (n = 170; age range, 4-36 months), rAOM (n = 54; age range, 7-36 months), and OME (n = 30; age range, 9-60 months) subjects tested immediately after withdrawal was similar (mean = 8.0;range 7.0-9.0); 3) biofilms formed optimally at pH 8.0, a finding that is consistent with previous studies by other investigators; 4) biofilms did not form under aerobic conditions as likely occurs in AOM, whereas under microaerophilic and anaerobic conditions biofilm formation was observed as likely occurs during rAOM and OME. CONCLUSIONS: We concluded that biofilm formation by NTHi does not occur in all strains, occurs best where the pH = 8.0 and in anaerobic conditions as likely occurs in children during rAOM and OME. However, biofilm formation is limited or absent under aerobic conditions as likely occurs during AOM. LEVEL OF EVIDENCE: NA.

Comparison of four DNA extraction methods for the detection of Mycobacterium leprae from Ziehl-Neelsen-stained microscopic slides.

OBJECTIVE/BACKGROUND: The diagnosis of leprosy has been a challenge due to the low sensibility of the conventional methods and the impossibility of culturing the causative organism. In this study, four methods for Mycobacterium leprae nucleic-acid extraction from Ziehl-Neelsen-stained slides (ZNS slides) were compared: Phenol/chloroform, Chelex 100 resin, and two commercial kits (Wizard Genomic DNA Purification Kit and QIAamp DNA Mini Kit). METHODS: DNA was extracted from four groups of slides: a high-codification-slide group (bacteriological index [BI]⩾4), a low-codification-slide group (BI=1), a negative-slide group (BI=0), and a negative-control-slide group (BI=0). Quality DNA was evidenced by the amplification of specific repetitive element present in M. leprae genomic DNA (RLEP) using a nested polymerase chain reaction. RESULTS: This is the first report comparing four different extraction methods for obtaining M. leprae DNA from ZNS slides in Cuban patients, and applied in molecular diagnosis. Good-quality DNA and positive amplification were detected in the high-codification-slide group with the four methods, while from the low-codification-slide group only the QIAGEN and phenol-chloroform methods obtained amplification of M. leprae. In the negative-slide group, only the QIAGEN method was able to obtain DNA with sufficient quality for positive amplification of the RLEP region. No amplification was observed in the negative-control-slide group by any method. Patients with ZNS negative slides can still transmit the infection, and molecular methods can help identify and treat them, interrupting the chain of transmission and preventing the onset of disabilities. CONCLUSION: The ZNS slides can be sent easily to reference laboratories for later molecular analysis that can be useful not only to improve the diagnosis, but also for the application of other molecular techniques.

Comparability of a three-dimensional structure in biopharmaceuticals using spectroscopic methods.

Protein structure depends on weak interactions and covalent bonds, like disulfide bridges, established according to the environmental conditions. Here, we present the validation of two spectroscopic methodologies for the measurement of free and unoxidized thiols, as an attribute of structural integrity, using 5,5'-dithionitrobenzoic acid (DTNB) and DyLight Maleimide (DLM) as derivatizing agents. These methods were used to compare Rituximab and Etanercept products from different manufacturers. Physicochemical comparability was demonstrated for Rituximab products as DTNB showed no statistical differences under native, denaturing, and denaturing-reducing conditions, with Student's t-test P values of 0.6233, 0.4022, and 0.1475, respectively. While for Etanercept products no statistical differences were observed under native (P = 0.0758) and denaturing conditions (P = 0.2450), denaturing-reducing conditions revealed cysteine contents of 98% and 101%, towards the theoretical value of 58, for the evaluated products from different Etanercept manufacturers. DLM supported equality between Rituximab products under native (P = 0.7499) and denaturing conditions (P = 0.8027), but showed statistical differences among Etanercept products under native conditions (P < 0.001). DLM suggested that Infinitam has fewer exposed thiols than Enbrel, although DTNB method, circular dichroism (CD), fluorescence (TCSPC), and activity (TNF α neutralization) showed no differences. Overall, this data revealed the capabilities and drawbacks of each thiol quantification technique and their correlation with protein structure.