scholarly journals Los aptámeros como novedosa herramienta diagnóstica y terapéutica y su potencial uso en parasitología

Biomédica ◽  
2020 ◽  
Vol 40 (Supl. 1) ◽  
pp. 148-165
Author(s):  
Juan David Ospina
Keyword(s):  
Trypanosoma Cruzi ◽  
Entamoeba Histolytica ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Leishmania Spp

Los aptámeros son secuencias de ADN o ARN de cadena sencilla que adoptan la forma de estructuras tridimensionales únicas, lo cual les permite reconocer un blanco específico con gran afinidad. Sus usos potenciales abarcan, entre otros, el diagnóstico de enfermedades, el desarrollo de nuevos agentes terapéuticos, la detección de riesgos alimentarios, la producción de biosensores, la detección de toxinas, el transporte de fármacos en el organismo y la señalización de nanopartículas.El pegaptanib es el único aptámero aprobado para uso comercial por la Food and Drug Administration (FDA). En parasitología, se destacan los estudios que se vienen realizando en Leishmania spp., con la obtención de aptámeros que reconocen la proteína de unión a poliA (LiPABP) y que pueden tener potencial utilidad en la investigación, el diagnóstico y el tratamiento de la leishmaniasis. En cuanto a la malaria, se han obtenido aptámeros que permiten identificar eritrocitos infectados e inhiben la formación de rosetas, y otros que prometen ser alternativas para el diagnóstico al detectar de forma específica la proteína lactato deshidrogenasa (PfLDH). Para Cryptosporidium parvuum se han seleccionado aptámeros que detectan ooquistes a partir de alimentos o aguas contaminadas. Para Entamoeba histolytica se han aislado dos aptámeros llamados C4 y C5, que inhiben la proliferación in vitro de los trofozoítos y tienen potencial terapéutico. Los aptámeros contra Trypanosoma cruzi inhiben la invasión de células LLC-MK2 (de riñón de mono) en un 50 a 70 % y aquellos contra T. brucei transportan moléculas tóxicas al lisosoma parasitario como una novedosa estrategia terapéutica.

scholarly journals US Food and Drug Administration Perspectives on Clinical Mass Spectrometry

2016 ◽  
Vol 62 (1) ◽  
pp. 41-47 ◽  
Author(s):  
Julia Tait Lathrop ◽  
Douglas A Jeffery ◽  
Yvonne R Shea ◽  
Peter F Scholl ◽  
Maria M Chan
Keyword(s):  
Mass Spectrometry ◽  
Clinical Trials ◽  
Drug Administration ◽  
Review Process ◽  
Food And Drug Administration ◽  
Regulatory Review ◽  
In Vitro Diagnostic ◽  
Guidance Documents ◽  
Proteins And Peptides

Abstract Mass spectrometry–based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry–based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry–based devices and enhance their entry into the clinic.

scholarly journals In Vitro Activities of Tigecycline against Clinical Isolates of Aeromonas, Vibrio, and Salmonella Species in Taiwan

2008 ◽  
Vol 52 (7) ◽  
pp. 2677-2679 ◽  
Author(s):  
Chia-Ying Liu ◽  
Yu-Tsung Huang ◽  
Chun-Hsing Liao ◽  
Po-Ren Hsueh
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Clinical Isolates

ABSTRACT All 198 Salmonella isolates (58.6% of isolates were resistant to tetracycline), 92 Vibrio isolates (4.4% of isolates were resistant to tetracycline), and 200 of 201 Aeromonas isolates (39.3% of isolates were resistant to tetracycline; 1 A. caviae isolate had a tigecycline MIC of 4 μg/ml) in our study were susceptible to tigecycline, by U. S. Food and Drug Administration criteria for Enterobacteriaceae.

In vitro metabolic interaction studies: Experience of the Food and Drug Administration

1999 ◽  
Vol 66 (1) ◽  
pp. 9-15 ◽  
Author(s):  
R YUAN ◽  
T PARMELEE ◽  
J BALIAN ◽  
R UPPOOR ◽  
F AJAYI ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Metabolic Interaction ◽  
Interaction Studies

Activity of a hydroxybibenzyl bryophyte constituent against Leishmania spp. and Trypanosoma cruzi: In silico, in vitro and in vivo activity studies

2008 ◽  
Vol 43 (9) ◽  
pp. 1797-1807 ◽  
Author(s):  
Virginia Roldos ◽  
Hector Nakayama ◽  
Miriam Rolón ◽  
Alina Montero-Torres ◽  
Fernando Trucco ◽  
...  
Keyword(s):  
Trypanosoma Cruzi ◽  
In Silico ◽  
Leishmania Spp

Verification of Performance Specifications of a Molecular Test: Cystic Fibrosis Carrier Testing Using the Luminex Liquid Bead Array

2012 ◽  
Vol 136 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Felicitas L Lacbawan ◽  
Karen E Weck ◽  
Jeffrey A Kant ◽  
Gerald L Feldman ◽  
Iris Schrijver ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Drug Administration ◽  
Clinical Laboratory ◽  
Food And Drug Administration ◽  
Carrier Testing ◽  
Clinical Diagnostic Laboratory ◽  
Cystic Fibrosis Carrier ◽  
Performance Specifications ◽  
In Vitro Diagnostic

Context.—The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration–approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. Objective.—To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). Design.—The approach used by an individual laboratory for verification of a US Food and Drug Administration–approved assay is described. Results.—Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Conclusions.—Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.

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