Development and validation of analytical techniques for the determination of blood biomarkers in preclinical trials: Why and what for?

El descubrimiento de un nuevo principio activo farmacéutico implica estudios preclínicos, que tienen como objetivo demostrar que es eficaz y seguro para un posterior ensayo en seres humanos. Esto conduce a la necesidad de desarrollar tecnologías que aprovechen las nuevas herramientas analíticas disponibles dentro de un contexto donde los resultados de las pruebas realizadas, estén plenamente documentados, bajo sistemas de buenas prácticas de laboratorio auditables. En esta revisión se actualizan y describen algunos de los ensayos realizados en la etapa preclínica del desarrollo de un nuevo fármaco y el estado actual de la tecnología analítica empleada para el dosaje de diferentes biomarcadores sanguíneos de interés. Se analizaron los biomarcadores más relevantes, las normativas de validación de las técnicas analíticas empleadas para su determinación y los problemas que se presentan al tratar de aplicarlas.New drug discovery involves preclinical studies to demonstrate its effectivity and safety for further tests in humans. This leads to the need to develop technologies that take advantage of the new analytical tools available within a context where the results of the tests carried out are fully documented, under auditable systems of good laboratory practice. This review updates and describes some of the tests carried out in the preclinical stage of the development of a new drug and the current state of the analytical technology used to measure different blood biomarkers of interest. Biomarker parameters were analyzed at the physiological level, considering both the validation regulations of the analytical techniques used for their determination as the problems that arise when trying to apply them, since many of these biomarkers are endogenous compounds in the used matrices.Fil: Santiago, Gonzalo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Salinas, Facundo José. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Cabaña, Enzo Rubén. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias; ArgentinaFil: Stassi, Antonela Florencia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Ortega, Hugo Hector. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; ArgentinaFil: Hein, Gustavo Juan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe. Instituto de Ciencias Veterinarias del Litoral. Universidad Nacional del Litoral. Facultad de Ciencias Veterinarias. Instituto de Ciencias Veterinarias del Litoral; Argentin

Official food safety audits in large scale retail trades in the time of COVID: system control experiences supported by an innovative approach

This work describes a new methodology used in large scale retail trades in official food safety auditing processes developed during COVID19 emergency. The aim is to evaluate Food Business Operators’ (FBOs) Food Safety Management System and its dynamic implementation and to understand the FBO’s level of cultural maturity about food safety according to EU Regulation 2021/382. The innovation mainly consists of: a) a pre-audit phase when auditors analyse food business operator’s (FBO) selfchecked plan and further documents to identify “markers” and useful evidences (that would be collected in on-site inspections) to evaluate the application of plan by FBO’s workers; b) an audit phase consisted of both a check of the company procedures and documents performed by the auditors via web conference and of contextually onsite inspections in a sample of company’s supermarkets performed by inspectors teams. The audit methodology here described may be useful, even though it is expensive in terms of time and energy used, for both Competent Authority (CA) and FBOs, regardless of the period of the COVID emergency. The so-structured official control allows the auditors to collect both documentary and on-site evidence at the same time, reaching a broader vision of auditees (not limited to single supermarkets) and a compliant with reality FBOs risk classification. The new approach may give advantages to both audit actors, CA as well as FBO, who may collect “markers” and evidence of the self-checked plan useful to improve FBO’s food safety system on the basis of the critical aspects detected during auditing process

ROLE OF IL-4 AND IL-10 CYTOKYNES IN THE PATHOGENIC MECHANISM OF THYROID CANCER.

Thyroid cancer is cancer of the thyroid gland. These may be of many types including papillary, follicular, Hurthle cell (aka oxyphilic or oncocytic), or medullary cancers. Surgery plays an important role in treating these cancers. The thyroid concentrates iodine and so is extremely sensitive to the effects of various radioactive isotopes of iodine produced by nuclear fission. These radioactive isotopes increase the chances of developing cancer, though thyroid cancer can develop even without any exposure to radioactivity. Some evidence suggests that insufficient or excessive dietary iodine may also increase the risk for thyroid cancer. This new book presents the latest research in this field

Nanomechanical DNA resonators for sensing and structural analysis of DNA-ligand complexes

Intercalating molecules can significantly change the conformation of DNA. Here, the authors fabricated resonators fully composed of DNA forming bundles between microfabricated pillars to study the vibration property of the DNA bundles with/without intercalant molecules