Propagation of uncertainty in nasal spray in vitro performance models using Monte Carlo simulation: Part I. model prediction using Monte Carlo Simulation**The views presented in this article do not necessarily reflect those of the Food and Drug Administration.

2010 ◽  
Vol 99 (4) ◽  
pp. 2114-2122 ◽  
Author(s):  
Changning Guo ◽  
William H. Doub ◽  
John F. Kauffman
Keyword(s):  
Monte Carlo Simulation ◽  
Monte Carlo ◽  
Nasal Spray ◽  
Drug Administration ◽  
Model Prediction ◽  
Food And Drug Administration ◽  
Performance Models ◽  
Propagation Of Uncertainty ◽  
In Vitro Performance

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.

BeO-OSL detectors for dose measurements in cell cultures

2009 ◽  
Vol 48 (06) ◽  
pp. 227-232
Author(s):  
D. Sommer ◽  
R. Freudenberg ◽  
U. Reichelt ◽  
J. Henniger ◽  
J. Kotzerke ◽  
...  
Keyword(s):  
Cell Culture ◽  
Monte Carlo Simulation ◽  
Monte Carlo ◽  
Cell Cultures ◽  
Rate Sensitivity ◽  
Culture Vessel ◽  
Qualitative Properties ◽  
Dose Profile ◽  
Ambient Lighting

Summary Aim: The absorbed dose is an important parameter in experiments involving irradiation of cells in vitro with unsealed radionuclides. Typically, this is estimated with a model calculation, although the results thus obtained cannot be verified. Generally used real-time measurement methods are not applicable in this setting. A new detector material with in vitro suitability is the subject of this work. Methods: Optically-stimulated luminescence (OSL) dosimeters based on beryllium oxide (BeO) were used for dose measurement in cell cultures exposed to unsealed radionuclides. Their qualitative properties (e. g. energy-dependent count rate sensitivity, fading, contamination by radioactive liquids) were determined and compared to the results of a Monte Carlo simulation (using AMOS software). OSL dosimeters were tested in common cell culture setups with a known geometry. Results: Dose reproducibility of the OSL dosimeters was ± 1.5%. Fading at room temperature was 0.07% per day. Dose loss (optically-stimulated deletion) under ambient lighting conditions was 0.5% per minute. The Monte Carlo simulation for the relative sensitivity at different beta energies provided corresponding results to those obtained with the OSL dosimeters. Dose profile measurements using a 6 well plate and 14 ml PP tube showed that the geometry of the cell culture vessel has a marked influence on dose distribution with 188Re. Conclusion: A new dosimeter system was calibrated with β-emitters of different energy. It turned out as suitable for measuring dose in liquids. The dose profile measurements obtained are suitably precise to be used as a check against theoretical dose calculations.

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
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