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Validation of the production process of core-equipment HYNIC-Bombesin-Sn; Validacion del proceso de produccion del nucleo-equipo HYNIC-Bombesina-Sn

Abstract

The validation process is establishing documented evidence that provides a high degree of assurance that a specific process consistently will produce a product that will meet specifications and quality attributes preset and, therefore, ensures the efficiency and effectiveness of a product. The radiopharmaceutical {sup 99m}Tc-HYNlC-Bombesin is part of the gastrin-releasing peptide (GRP) analogues of bombesin that are radiolabelled with technetium 99 metastable for molecular images obtention. Is obtained from freeze-dry formulations kits (core- equipment)) and has reported a very high stability in human serum, specific binding to receptors and rapid internalization. Biodistribution data in mice showed rapid blood clearance with predominant renal excretion and specific binding to tissues with positive response to GRP receptors. According to biokinetics studies performed on patients with breast cancer, breast show a marked asymmetry with increased uptake in neoplastic breast in healthy women and the uptake of radiopharmaceuticals is symmetrical in both breasts. No reported adverse reactions. In this paper, the prospective validation core-equipment HYNlC-Bombesin-Sn, which was shown consistently that the product meets the specifications and quality, attributes to preset from the obtained from the diagnostic radiopharmaceutical third generation: {sup 99m}Tc-HYNlC-Bombesin. The process was successfully validated and thereby ensuring the efficiency and effectiveness of this  More>>
Authors:
Rubio C, N I [1] 
  1. ININ, 52045 Ocoyoacac, Estado de Mexico (Mexico)
Publication Date:
Jul 01, 2008
Product Type:
Thesis/Dissertation
Report Number:
INIS-MX-2541
Resource Relation:
Other Information: TH: Thesis (Chemical Pharmaceutical and Biology)
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; DIAGNOSTIC USES; EVALUATED DATA; EVALUATION; GASTRIN; ISOTOPE PRODUCTION; NUCLEAR MEDICINE; PEPTIDES; QUALITY CONTROL; RADIOISOTOPE GENERATORS; RADIOPHARMACEUTICALS; RECEPTORS; SPECIFICATIONS; VALIDATION
OSTI ID:
21217641
Research Organizations:
Universidad Autonoma del Estado de Mexico, Facultad de Quimica, 50000 Toluca, Estado de Mexico (Mexico)
Country of Origin:
Mexico
Language:
Spanish
Other Identifying Numbers:
TRN: MX0900079086425
Availability:
Available from INIS in electronic form; Also available from the Instituto Nacional de Investigaciones Nucleares, Centro de Informacion y Documentacion Nuclear, 52045 Ocoyoacac, Estado de Mexico (MX). e-mail: claudio.fernandez@inin.gob.mx; javier.ortega@inin.gob.mx
Submitting Site:
MXN
Size:
164 pages
Announcement Date:
Oct 17, 2009

Citation Formats

Rubio C, N I. Validation of the production process of core-equipment HYNIC-Bombesin-Sn; Validacion del proceso de produccion del nucleo-equipo HYNIC-Bombesina-Sn. Mexico: N. p., 2008. Web.
Rubio C, N I. Validation of the production process of core-equipment HYNIC-Bombesin-Sn; Validacion del proceso de produccion del nucleo-equipo HYNIC-Bombesina-Sn. Mexico.
Rubio C, N I. 2008. "Validation of the production process of core-equipment HYNIC-Bombesin-Sn; Validacion del proceso de produccion del nucleo-equipo HYNIC-Bombesina-Sn." Mexico.
@misc{etde_21217641,
title = {Validation of the production process of core-equipment HYNIC-Bombesin-Sn; Validacion del proceso de produccion del nucleo-equipo HYNIC-Bombesina-Sn}
author = {Rubio C, N I}
abstractNote = {The validation process is establishing documented evidence that provides a high degree of assurance that a specific process consistently will produce a product that will meet specifications and quality attributes preset and, therefore, ensures the efficiency and effectiveness of a product. The radiopharmaceutical {sup 99m}Tc-HYNlC-Bombesin is part of the gastrin-releasing peptide (GRP) analogues of bombesin that are radiolabelled with technetium 99 metastable for molecular images obtention. Is obtained from freeze-dry formulations kits (core- equipment)) and has reported a very high stability in human serum, specific binding to receptors and rapid internalization. Biodistribution data in mice showed rapid blood clearance with predominant renal excretion and specific binding to tissues with positive response to GRP receptors. According to biokinetics studies performed on patients with breast cancer, breast show a marked asymmetry with increased uptake in neoplastic breast in healthy women and the uptake of radiopharmaceuticals is symmetrical in both breasts. No reported adverse reactions. In this paper, the prospective validation core-equipment HYNlC-Bombesin-Sn, which was shown consistently that the product meets the specifications and quality, attributes to preset from the obtained from the diagnostic radiopharmaceutical third generation: {sup 99m}Tc-HYNlC-Bombesin. The process was successfully validated and thereby ensuring the efficiency and effectiveness of this agent as a preliminary diagnostic for approval to be marketed. (Author)}
place = {Mexico}
year = {2008}
month = {Jul}
}