Categoría: Estudios de seguridad

Estudio Preclínico PK y Reducción del Estrés Oxidativo

noviembre 18, 2023
In a preclinical study completed in November of 2023 by Dr. José Trinidad Pérez Urizar, Ph.D. a professor in the Biomedical Sciences Department of the University of San Luis Potosí. The preclinical study’s objective was to characterize the systemic bioavailability of the metal ions - Magnesium (Mg+2), Zinc (Zn+2), and Copper (Cu+2) contained in the […]

Estudio de fase I para determinar la tolerabilidad tópica de Ion Gel ZCM-25®

abril 27, 2023
To evaluate the tolerability of the product Ion Gel ZCM-25®, measured as the degree of irritability: edema and/or erythema, during 14 days of administration in healthy subjects. Methods. Twenty research subjects of both sexes were recruited, a dose of 0.5 mL of the topical treatment was administered for 14 days and evaluated during 15 visits; […]

Estudio clínico de fase 1 del Ion Gel ZCM-25® en humanos

octubre 5, 2020
In the present study, the tolerability of the Class II Medical Device, Ion Gel ZCM-25 was evaluated after daily administration for 14 days, the dose of 0.5mL on the intact skin of the left arm of 20 healthy subjects of both sexes, according to the Authorized Research Protocol, NOM-177-SSA1-2013, NOM-012-SSA3-2012 for compliance with Good Clinical Practice and NOM-220-SSA1-2016 in compliance with Pharmacovigilance; as well as in compliance with current sanitary regulations in Mexico.

Tabla de comparación de la dosificación de Ion Gel ZCM-25®

julio 24, 2020
Tabla de comparación de la dosificación de Ion Gel ZCM-25® a través de varios estudios de dosificación en humanos y animales.

Estudio de irritabilidad dérmica de dosis única del Ion Gel ZCM-25® en conejos machos de Nueva Zelanda

agosto 13, 2019
Abstract Study Title: Dermal Irritability Single High Dose Study of Ion Gel ZCM-25® on New Zealand Male Rabbits Author: UNAM - Preclinical Research Unit - UNIPREC - Dr. Azucena Ibeth Carballo Villalobos (Principal Investigator) (2019). Methods: A dermal irritation study of the product Ion Gel ZCM-25® as a single dose 0.5 ml over an area […]

Estudio de irritabilidad dérmica de 3 días de dosificación del Ion Gel ZCM-25® en conejos machos de Nueva Zelanda.

julio 19, 2018
Abstract Study Title: Dermal Irritability 3 Day Dosing Study of Ion Gel ZCM-25® on New Zealand Male Rabbits. Author: Center of Investigation and Assistance in Technology and Design of the State of Jalisco A.C, - CIATEJ. Dr. en C. Eduardo Padilla Camberos (2018). Methods: A dermal irritation study of the product Ion Gel ZCM-25® as […]

Estudio de toxicidad In vitro de ION-ZCM1 en células humanas utilizando un método de ensayo de citotoxicidad MTT

junio 26, 2018
Abstract Study Title: In vitro Toxicity Study of ION-ZCM1 on Human Cells Using an MTT Cytotoxicity Test Method Author: INDEVION Biotechnology Research and Development Ltd. Principal Investigator Dr. Zsolt Keresztessy, Ph.D. (2018). Methods: The data generated from the in vitro cytotoxicity assays were used to predict toxicity under cell culture conditions, based on the HACAT […]
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